louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02352597: Phytoestrogens as an Alternative to Estradiol in Ovulation Induction in PCOS
Official title: Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovaries
Keywords: PCOS
Phytoestrogens
ovulation induction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-02-02
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective study conducted on 150 women with polycystic ovarian syndrome (PCOS) were randomly divided into 3 groups: group I (50 women) received clomiphene citrate (CC) only 50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Detailed description: Prospective study conducted on 150 women with PCOS were randomly divided into 3 groups: group I (50 women) received CC only50 mg orally every 8 hours started from cycle day 3 for 5 days, group II (50 women) received 2mg estradiol valerate daily from cycle day 7 - 11 in addition to CC and group III (50 women) received phytoestrogen (20mg of cimifuga racemosa from day 1- 12) in addition to CC.

Eligibility criteria: Inclusion Criteria:

Women with both 1ry and 2ry infertility were included. All women were between 20 and 37 years old.

Exclusion Criteria:

women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels, those with hypothalamic or pituitary dysfunctions evaluated by low gonadotropin level, other causes of infertility as tubal factor evaluated by HSG or laparoscopy, abnormal uterine cavity evaluated by sonohystrography or hysteroscopy and male factor evaluated by semen analysis. Women with ovarian cysts were also excluded from the study

Primary outcomes:
measure: endometrial thickness
timeFrame: day 14 of menstrual cycle
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00176397: Percutaneous Coronary Intervention (PCI) With Drug-Eluting Stents (DES) Versus Coronary Artery Bypass Graft (CABG) for Patients With Significant Left Main Stenosis
Official title: PCI With DES Versus CABG for Patients With Significant Left Main Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Coronary Stenosis
Coronary Artery Disease
Keywords: left main coronary artery
coronary artery disease
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

Detailed description: Recent technical advances in percutaneous coronary interventions have made it possible to approach patients with coronary lesions formerly considered to be classical candidates for bypass surgery, e.g. patients with left main coronary stenosis. However, it is still unclear whether the good long-term results achieved with the surgical therapy can be reproduced by an interventional strategy using drug-eluting stents (DES).

The aim of the current trial is, therefore, to compare the clinical and angiographic results of PCI and CABG in patients with left main coronary stenosis.

The study was planned as a "non-inferiority" trial based on the hypothesis that PCI may be able to reach similar long-term results as compared to CABG.

Eligibility criteria: Inclusion Criteria:

* Significant left main coronary stenosis \>= 50%

Exclusion Criteria:

* Acute myocardial infarction (STEMI \< 48h)

Primary outcomes:
measure: Major adverse coronary events (cardiac death, myocardial infarction, need for repeat revascularisation)
Secondary outcomes:
measure: Functional status (CCS-class)
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center
state: Saxony
Study officials:
affiliation: University of Leipzig
name: Gerhard Schuler, MD
role: STUDY_DIRECTOR
affiliation: University of Leipzig
name: Friedrich Mohr, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01763697: Taste Acuity and Caloric Intake After Acute Morphine Administration
Official title: Taste Acuity and Caloric Intake After Acute Morphine Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Taste Sweet
Taste Salty
Feeding Behavior
Keywords: Taste acuity
Feeding behavior
opioid
Quantitative assessment
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-01-09
Enrollment: 36
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: BASIC_SCIENCE

Brief summary: This study will investigate the effects of acute morphine administration on taste acuity and how much a person eats. It is hypothesized that there will be a dose dependent decrease in taste acuity and dose dependent increase in food intake associated with acute morphine administration. Knowledge from this study will impact the future of feeding behavior and obesity research in the general population. Results will also promote exploration of the long-term effect of opioid abuse on taste acuity and feeding behavior in substance abusing populations.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male and female volunteers
* Ages of 18 to 65

Exclusion Criteria:

* History of drug dependence (including opioid use disorders)
* History of taste dysfunction
* Significant medical or Axis I psychiatric disorder
* Any trauma or surgical procedures to the head or neck region
* Medication or illicit drug more than 4 out of the last 30 days.
* Pregnancy
* Abnormal electrocardiogram findings
* Negative rating of greater than 40% of the foods available for consumption

Primary outcomes:
measure: Taste
timeFrame: 3 hours after dose administration
Secondary outcomes:
measure: Calories
timeFrame: 6 hours after dose administration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Denis G Antoine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03679897: Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block
Official title: 0.25% Levobupivacaine Versus 0.375% Ropivacaine: a Comparative Study in Ultrasound-Guided Infraclavicular Brachial Plexus Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Regional Anesthesia
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 46
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infraclavicular brachial plexus block has been used more frequently with the development of high-resolution ultrasound. Compared with peripheral nerve block using landmark technique or nerve stimulator technique, ultrasound-guided peripheral nerve block decreases the required dose of local anesthetics. As the dose of the drug used decreases, the systemic toxic effects of local anesthetics are reduced. However, the decreased dose of the drugs might have influence on the onset time of local anesthetics. Thus, the investigator aimed to evaluated the onset time of the two equipotent local anesthetics, 0.375% ropivacaine and 0.25% levobupivacaine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status 1-3
* Patients undergoing upper extremity surgery with infraclavicular brachial plexus block

Exclusion Criteria:

* Patients who do not agree to participate in clinical trial
* Patients presenting with neurological deficits of the upper arm, severe coagulopathy, chronic renal failure, cardiopulmonary compromise, cerebral vascular disease, hypersensitivity to hyaluronidase or local anesthetics or local infection at the site of the infraclavicular block, pregnancy

Primary outcomes:
measure: onset time of sensory block
timeFrame: up to 40 minutes
Secondary outcomes:
measure: onset time of motor block
timeFrame: up to 40 minutes
measure: duration of analgesia
timeFrame: 24 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: University of Ulsan, College of Medicine, Asan Medical Center
name: Won Uk Koh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Lee S, Chin KJ, Kim JS, Kim H, Ro YJ, Koh WU. Comparison of the onset time between 0.375% ropivacaine and 0.25% levobupivacaine for ultrasound-guided infraclavicular brachial plexus block: a randomized-controlled trial. Sci Rep. 2021 Feb 25;11(1):4703. doi: 10.1038/s41598-021-84172-2.
Clinical trial NCT02447497: In Vivo Patient Preoperative Skin Prep Persistence
Official title: Assessment of Antimicrobial Persistence of 3M CHG/IPA Preoperative Skin Preparation Against Resident Flora on the Abdominal and Inguinal Regions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bacterial Recovery of Skin Flora Post-Product Application
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2015-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

Detailed description: The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

Eligibility criteria: Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Primary outcomes:
measure: Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
timeFrame: Baseline, 48 hours and 72 hours post-prep application
Secondary outcomes:
measure: Safety as Assessed by Skin Irritation Scores Coded by Study Staff
timeFrame: 48 hours and 72 hours post-product application
measure: Safety as Assessed by Adverse Events
timeFrame: To 72 hours post treatment
Other outcomes:
Locations:
city: Sterling
country: United States
facility: MicroBioTest
state: Virginia
Study officials:
affiliation: MicroBioTest Inc.
name: Muhammad H Bashir, MD, CCRP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03215797: Phenylephrine or Norepinephrine for a Better Hemodynamic Stability
Official title: Comparison of the Effects of Norepinephrine and Phenylephrine on Tissue Oxygenation and Hemodynamic Stability During an SVV Fluid Guided Therapy in Elderly Undergoing Radical Resection of Colon Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypotension
Fluid Therapy
Keywords: svv
norepinephrine
phenylephrine
elderly
Lead sponsor: The Second Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2017-07-12
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, double-blinded study. The present study consisted in applying Stroke volume variation fluid guided therapy to old patients (65 years old) undergoing radical resection of colon surgery. The aim of this study is to compare the effects of norepinephrine and phenylephrine in treating perioperative hypotension, and to find the safest and most effective vasopressor for elderly.

Detailed description: Fluid management has a great influence on patient's morbidity, mortality and on the overall outcome.Goal directed therapy was proved by multiple studies to be a goal therapy in maintaining a stable hemodynamic state. Nevertheless, as the population worldwide is aging, elderly presenting for surgery are also increasing. This population is known for the multiple comorbidities and physiological changes which makes them prone to dehydration and hypotension. That's when we are going to use either Norepinephrine in one group or Phenylephrine in the other and compare the effects of both vasopressors.

Parameters we are going to use are: Hemodynamic (HR, MAP, CO, CI, SVV, SV); Tissue Oxygenation and perfusion (DO2, VO2, ERO2, CRT, Lactate, blood gas); Urine output.

Eligibility criteria: Inclusion Criteria:

* Operation time should be equal or greater than 2h,
* Patients older than 65 years old,
* ASA Ⅱ or Ⅲ.

Exclusion Criteria:

* Clear arrhythmia,
* Need to apply PEEP,
* Peripheral vascular disease and arterial catheter contraindications.

Primary outcomes:
measure: the tissue oxygenation
timeFrame: from the beginning of surgery to the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02355197: Antioxidants in Gestational Diabetes
Official title: Physiological Effects of Gestational Diabetes on the Placenta and Neonatal Outcome; Role of Antioxidant Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gestational Diabetes Mellitus
Keywords: antioxidants
Gestational diabetes mellitus
oxidative stress
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2015-02-04
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fasting and two hours postprandial blood sugar were done to all cases between 28 and 32 weeks and high blood sugar levels were found so Cases were controlled by both diet and insulin.

The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes

Detailed description: The 200 pregnant women with Gestational diabetes mellitus were randomized using automated web based randomization system into 2 groups, Group1 received 1 gram L-ascorbic acid oral once daily (vitamin C )per day from the time of diagnosis until the time of delivery in addition to routine treatment of diabetes (diet \& insulin). Group2 received only the treatment of diabetes (diet and insulin

Eligibility criteria: Inclusion Criteria:

* Women with the diagnosis of GDM

Exclusion Criteria:

* Women with multiple pregnancies
* Chronic medical disorders e.g. anemia
* Hypertension
* Liver disease or renal disease
* Those with obstetric problems other than GDM (e.g. pre-eclampsia \& antepartum hemorrhage) or smokers and women with preexisting type I or II diabetes mellitus were excluded from our study

Primary outcomes:
measure: neonatal outcome assessed by neonatal ICU admission
timeFrame: 1 week after delivery
Secondary outcomes:
measure: oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in placental tissue homogenates in women with GDM named glutathione ,malondialdahyde,superoxide dismutase ,catalase and glutathione peroxidase
timeFrame: 9 months of pregnancy
measure: oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in maternal blood plasma/lysate in women with GDM named glutathione,superoxide dismutase ,catalase and glutathione peroxidase
timeFrame: 9 months of pregnancy
measure: oxidative stress parameters: non enzymatic and enzymatic oxidative stress parameters in neonatal blood in women with GDM named malondialdahyde and superoxide dismutase
timeFrame: 9 months of pregnancy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02329197: Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Invitro Fertilization
Keywords: Infertility
Invitro fertilization
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 380
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

Detailed description: Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle. Following controlled ovarian hyperstimulation, ovum pick up and at the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.

Eligibility criteria: Inclusion Criteria:

- women with previous IVF failure undergoing fresh IVF cycle

Exclusion Criteria:

* women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps

Primary outcomes:
measure: Live Birth
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Teaching Hospital
Study officials:
affiliation: Mansoura University
name: Ahmed Gibreel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03055897: Tear Film Innovations iLux Safety Study
Official title: Tear Film Innovations iLux Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Evaporative Dry Eye
Lead sponsor: Tear Film Innovations, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to measure the temperature of the cornea and surrounding eye tissue temperature immediately after heating the eyelids with the iLux device using the protocol treatment profile. Eligible participants attended one treatment visit, with follow-up one day following the procedure.

Detailed description: Alcon Research, LLC, acquired TearFilm Innovations, Inc., in December 2018. This study was designed and conducted by TearFilm Innovations, Inc. The study results were collected, analyzed, and provided by TearFilm Innovations, Inc., to Alcon Research, LLC.

Eligibility criteria: Key Inclusion Criteria:

- Sign written informed consent prior to study participation

Key Exclusion Criteria:

* History of ocular surgery within 1 year
* Active ocular infection
* Ocular surface abnormality; lid surface abnormalities
* Pregnant, nursing or not utilizing adequate birth control measures
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Mean Overall Maximum Temperature of the Cornea and Surrounding Eye Tissue Immediately Post-treatment
timeFrame: Day 0 immediately post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: TearFilm Innovations Investigative Site
state: California
Study officials:
affiliation: Alcon Research, LLC
name: Sr. CDMA Project Lead, CDMA Ocular Health
role: STUDY_DIRECTOR
References:
Clinical trial NCT01371097: Progressive Resistance Strength Training (PRT) in Hospitalised Elderly Patients
Official title: The Effect of Progressive Resistance Strength Training in Hospitalised Elderly Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Diseases
Neurological Diseases
Chronical Obstructive Lung Diseases
Keywords: Barthel Index
elderly hospitalised patients
progressive resistance training
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2011-06-10
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effect of progressive resistance strength training (PRT) in elderly hospitalised patients. The hypothesis is that PRT given as an additional training would improve the rehabilitation and increase the level of activity of daily living.

Detailed description: Elderly inpatients included in the study were randomised into a control group or a training group. All included patients received the regular in-physiotherapy, but the training group received progressive resistance training in groups in addition.

Eligibility criteria: Inclusion Criteria:

1. Hospitalised elderly patients referred for physiotherapy.
2. Ability to perform standing position independently with/without walking aids (rollator, crutch) or bed/bench support.

Exclusion Criteria:

1. Expected length of stay \< 7 days.
2. Dementia.
3. Unable to communicate relevant.
4. Unable to be active

Primary outcomes:
measure: Timed "Up & Go" Test
timeFrame: Before randomisation and 3 days before discharge from the department
Secondary outcomes:
measure: Barthel Index
timeFrame: before randomisation and 3 days before discharge from the department
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Copenhagen University Hospital, Glostrup
Study officials:
affiliation: Copenhagen University Hospital, Glostrup
name: Sigrid Tibaek, Dr Med Sci, PT
role: PRINCIPAL_INVESTIGATOR
References: