louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00620581: Luteal Phase Administration of Paroxetine for the Treatment of PMDD
Official title: Luteal Phase Administration of Paroxetine for the Treatment of PMDD: A Randomized, Double-Blind, Placebo-Controlled Trial in Canadian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Premenstrual Dysphoric Disorder
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-02-21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: The efficacy of SSRI use to relieve the symptoms associated with premenstrual dysphoric disorder has been established. We proposed to test the hypothesis that intermittent treatment with paroxetine administered during the luteal phase of the menstrual cycle only is more effective than placebo in improving symptoms of PMDD. This was a double-blind, placebo-controlled, three-arm parallel group study of patients with PMDD. Menstruating women 18 years of age or older who met criteria for inclusion in the study were randomized to one of three arms: paroxetine 10mg/day during the luteal phase of the menstrual cycle; paroxetine 20mg/day during the luteal phase of the menstrual cycle; placebo daily during the luteal phase of the menstrual cycle. The objective was to evaluate the efficacy and safety of intermittent treatment of paroxetine in women with PMDD.


Eligibility criteria: Inclusion Criteria:

* PMDD according to DSM-IV criteria

Exclusion Criteria:

* Women were excluded if they were taking oral contraception, breast-feeding, pregnant, or planning to become pregnant during the study period.
* Women were also excluded if they met DSM-IV criteria for any Axis I disorder, were deemed a suicidal risk, had a history of SSRI use for premenstrual symptoms, were taking ongoing medication that could affect PMDD symptoms, had a clinically significant abnormality on screening blood tests, or had a baseline Montgomery-Asberg Depression Rating Scale score of equal to or greater than 10 during the follicular phase of the menstrual cycle.

Primary outcomes:
measure: Visual Analogue Scales
Secondary outcomes:
measure: PMTS-O; CGI-S; Sheehan Disability Scale
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Women's Health Concerns Clinic
state: Ontario
Study officials:
References:
citation: Steiner M, Ravindran AV, LeMelledo JM, Carter D, Huang JO, Anonychuk AM, Simpson SD. Luteal phase administration of paroxetine for the treatment of premenstrual dysphoric disorder: a randomized, double-blind, placebo-controlled trial in Canadian women. J Clin Psychiatry. 2008 Jun;69(6):991-8. doi: 10.4088/jcp.v69n0616.
Clinical trial NCT06191081: Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis
Official title: Intraoperative Identification of the Optimal Functional Lymphatic Vessel for Lymphaticovenous Anastomosis in Upper Limb Extremity Lymphedema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged 18-80 years; Lymphedema and swelling of the limbs for more than 3 months

Brief summary: The aim of this study is to further explore the optimal screening factors for functional lymphatic vessels in lymphaticovenous anastomosis in patients with lymphedema.

Detailed description: By analyzing the size of lymphatic vessels (0.3-0.6mm), ICG imaging, contraction characteristics of lymphatic vessels and lymphatic flow in patients with lymphedema, the effect of functional lymphatic vessel selection on lymphatic drainage in patients with lymphedema was judged during operation, so as to provide a more scientific basis for the selection of functional lymphatic vessels in clinical surgery.

Eligibility criteria: Inclusion Criteria:

* lymphedema Paitent

Exclusion Criteria:

* myoedema Paitent；lipedema Paitent

Primary outcomes:
measure: Rate of size(0.3-0.6mm)
timeFrame: through study completion, an average of 2.5 year
measure: Rate of lymphatic vessels contractility
timeFrame: through study completion, an average of 2.5 year
measure: Rate of flow
timeFrame: through study completion, an average of 2.5 year
measure: Rate of ICG
timeFrame: through study completion, an average of 2.5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
facility: Chong Liu
Study officials:
affiliation: employee
name: youmao liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT05933681: Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Official title: Neurophysiology Biomarkers of Cognitive Impairment Associated With Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Parkinson Disease
Cognitive impairment
Movement Disorders
Brain Diseases
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-07-06
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to investigate cognitive impairment associated with Deep Brain Stimulation (DBS) in Parkinson's Disease patients, with a focus on identifying neurophysiology biomarkers of DBS associated cognitive changes. Using neurophysiology data recorded during DBS surgeries and post-implantation, the research intends to identify biomarkers in order to optimize electrode placement, enhance programming, and ultimately minimize DBS-related cognitive side effects.


Eligibility criteria: Inclusion Criteria:

• Scheduled to undergo deep brain stimulation surgery under local anesthesia at Vanderbilt University Medical Center (Arm 1)

* Active deep brain stimulation system with implantable pulse generator capable of recording local field potentials (Arm 2)
* Diagnosis of Parkinson's disease as determined by a movement disorders specialist neurologist
* Age at least 18
* Able to participate in intraoperative testing
* English speaking

Exclusion Criteria:

* Age less than 18
* Not able to participate in intraoperative testing (ex unable to comprehend instructions or follow directions)

Primary outcomes:
measure: Determination of DLPFC beta power a biomarker of DBS associated cognitive impairment in the acute stimulation setting
timeFrame: Baseline to end of Deep Brain Stimulation (DBS), approximately 3-4 hours
measure: Determination of STN local field potential biomarkers of DBS mediated cognitive impairment following chronic stimulation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sarah K Bick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922181: Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer
Official title: Single-probe Microwave Ablation of Metastatic Liver Cancer is Highly Variable and Irreproducible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Neoplasms
Keywords: malignancy
liver
microwave
surgery
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Microwave ablation (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate the variability and reproducibility of single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller than 3 cm in patients without underlying liver disease.


Eligibility criteria: Inclusion Criteria:

* Unresectable metastatic liver cancer
* No invasion of major biliary structures
* No invasion of major vascular structures
* ASA score \< 4
* WHO score 0-1
* Pre-operative chemotherapy is allowed

Exclusion Criteria:

* Resectable liver metastases
* Life expectancy less than 3 months
* Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials
* Coagulopathy with platelet count less than 50000
* Active infectious disease
* Age below 18 years
* Pregnancy of breastfeeding

Primary outcomes:
measure: Variability of ablation diameters
timeFrame: within the first 7 days and 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
state: Vlaams-Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Baki Topal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hompes R, Fieuws S, Aerts R, Thijs M, Penninckx F, Topal B. Results of single-probe microwave ablation of metastatic liver cancer. Eur J Surg Oncol. 2010 Aug;36(8):725-30. doi: 10.1016/j.ejso.2010.05.013. Epub 2010 Jun 3.
Clinical trial NCT02557581: cAMP Signaling and Muscle Adaptations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Hypertrophy in Healthy Young Men
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 72
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The role of cAMP signaling mediated by beta2-adrenergic stimulation with agonists has been well-studied in skeletal muscles of animals. Studies in humans are scant and the scope of the present study is thus to investigate the role of cAMP signaling by beta2-adrenergic stimulation for muscle adaptations in humans.


Eligibility criteria: Inclusion Criteria:

* healthy young men
* 18-35 years of age
* Informed consent
* Active 2-5 hours of training pr. week
* Maximal oxygen uptake (ml/min/kg) of 40-60
* Lean body mass of 55-65 kg / Lean mass index 14-22 kg/m2

Exclusion Criteria:

* Smoker
* Allergy towards study drugs
* Chronic disease

Primary outcomes:
measure: Muscle hypertrophy (lean body mass in Kilograms)
timeFrame: 2 days
Secondary outcomes:
measure: Energy turnover (ml/min or mmol/kg dry weight muscle)
timeFrame: 1 day
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
Study officials:
References:
Clinical trial NCT06783881: Single-ascending Dose Study of Kylo-12 in Healthy Subjects
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Kylo-12 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hypertriglyceridemia
Lead sponsor: Kylonova (Xiamen) Biopharma co., LTD.
Sponsor class: INDUSTRY
First posted: 2025-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study in healthy volunteers. Kylo-12 will be evaluated in approximately 50 subjects to assess safety, tolerability, pharmacokinetics and pharmacodynamic effects.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 55 years old, inclusive;
* Body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive;
* Protocol-defined elevated serum TG level;
* Female subjects must not be able to get pregnant and male subjects must agree to adhere to contraception restrictions;
* Willing to comply with protocol required visits and assessments, and provide written informed consent.

Exclusion Criteria:

* History or evidence of a clinically significant disorder, condition or disease;
* Received an investigational drug, vaccine or device within 3 months before dosing;
* History of evidence of malignant tumor or Gilbert syndrome;
* Positive screen of Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection;
* History of alcohol abuse within 12 months before dosing;
* History of drug abuse within 3 months before screening;
* History of blood donations or blood loss of 400 ml and more within 3 months before dosing;
* History of stroke or myocardial infarction within 6 months before sceening;
* Pregnant or breast-feeding women;
* Other exclusion criteria applied per protocol.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: up to Week 24
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: up to week 48
measure: Pharmacokinetics (PK) parameter of maximum observed concentration (Cmax)
timeFrame: up to Week 48
measure: PK parameter of time of maximum observed concentration (Tmax)
timeFrame: up to Week 48
measure: PK parameter of area under the concentration time curve (AUC)
timeFrame: up to Week 48
measure: Change in serum ApoC3 and TG over time
timeFrame: up to Week 48
measure: Percent change in serum ApoC3 and TG over time
timeFrame: up to Week 48
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Xinhua Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT01832181: MiTy Kids (Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial)
Official title: Metformin in Women With Type 2 Diabetes in Pregnancy Kids Trial (MiTy Kids)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Diabetes
MiTy
Metformin in Women
Type 2 Diabetes Pregnancy
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-04-15
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Offspring of women with type 2 diabetes who participated in the MiTy trial during pregnancy.

Brief summary: The prevalence of diabetes in pregnancy is rising in all maternal age groups. There is increasing evidence that in-utero exposure to maternal diabetes is associated with an increased risk of obesity and type 2 diabetes in children and adults. There is an urgent need to reduce these increasing rates of obesity and diabetes in subsequent generations.

The MiTy Trial (Metformin in Women with Type 2 Diabetes in Pregnancy Trial) is a CIHR-funded multi-centre, randomized controlled trial of women with type 2 diabetes in pregnancy (sample size n=500). The MiTy Trial is looking to determine the effect of the addition of metformin to a standard regimen of insulin in women with diabetes, on perinatal morbidity and mortality.

The MiTy Kids Trial is a follow-up to the MiTy Trial which will determine whether treatment with metformin during pregnancy in women with type 2 diabetes will lead to a reduction in adiposity and improvement in insulin resistance in the offspring of women with diabetes at 2 years of age.


Eligibility criteria: Inclusion Criteria:

* Offspring of women with type 2 diabetes who participated (or are participating) in the MiTy trial.

Exclusion Criteria:

* Offspring with major congenital anomalies.

Primary outcomes:
measure: Adiposity in the offspring
timeFrame: 24 months
Secondary outcomes:
measure: Sum of skinfolds in the offspring
timeFrame: 6, 12 and 24 months
measure: Central to peripheral adiposity in the offspring
timeFrame: 6, 12 and 24 months
measure: Weight gain, BMI and weight-for-length percentile change over time in critical early periods and overall in the offspring.
timeFrame: 3, 6, 12, 18 and 24 months
measure: Overweight and obesity in the offspring
timeFrame: 3, 6, 12, 18 and 24 months
measure: Insulin resistance in the offspring
timeFrame: 24 months
measure: adipocytokine profile in the offspring
timeFrame: 24 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Dr. Denice Feig
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Toronto, Ontario, Canada
name: Denice Feig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338481: "Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Lung Cancer
Official title: "Red Morphine Drops" for Symptomatic Treatment of Dyspnoea in Terminal Patients With Primary Lung Cancer or Lung metastases-a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dyspnea
Lung Neoplasms
Lead sponsor: Sankt Lukas Hospice
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 20
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: The purpose of this study is to test whether "red morphine drops" applied in the mouth are superior to an equivalent amount of morphine applied as subcutaneous injection for the relief of breathlessness in terminal patients suffering from primary lung cancer or lung metastases.

Detailed description: Breathlessness or dyspnea in terminal cancer patients with lung cancer is common and opioids such as morphine is the mainstay of symptomatic treatment. Subcutaneous administration of morphine provides fast symptomatic relief, but it has been the impression in our institution that "red morphine drops" applied orally may have equal or better efficacy and faster onset time.

Comparison: Patients with lung cancer or lung metastases with moderate to severe dyspnea at rest are treated with either orally applied "red morphine drops" or an equivalent amount of morphine applied subcutaneously.

Eligibility criteria: Inclusion Criteria:

* Primary lung cancer or lung metastases and
* Moderate to severe dyspnea at rest (VAS equal to or more than 30)

Exclusion Criteria:

* Causal treatment of dyspnea possible and indicated
* Not receiving opioids on a regular basis
* Methadone treatment
* Intolerance to morphine
* Without understanding of patient information
* Depressed consciousness
* Oxygen treatment, if changed with-in 20 min before start
* Short-acting opioids with-in 4 h before start
* Inhalation therapy for bronchodilation with-in 20 min before start

Primary outcomes:
measure: Dyspnea on a VAS scale
timeFrame: 1 hour
Secondary outcomes:
measure: Respiratory rate, pulse rate, oxygen saturation
timeFrame: 1 hour
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Sankt Lukas Hospice
state: Hellerup
Study officials:
affiliation: Sankt Lukas Hospice
name: Torben Krantz, Physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04952181: Comparison Between Different Investigations Used in Intraocular Lens Calculation in High Myopic Cataractous Patients
Official title: Optical Biometry Versus Ultrasonic Biometry in Intraocular Lens Calculation in High Myopic Cataractous Patients: A Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calculation of Intraocular Lens in High Myopic Cataractous Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: the purpose of the study is to compare the accuracy of optical and ultrasonic biometry in intraocular lens (IOL) calculation in high myopic cataractous patients

Detailed description: * Prospective interventional (QUASI experimental) comparative study
* This study will be conducted on high myopic cataractous patients scheduled for phacoemulsification and IOL implantation in department of ophthalmology, Sohag university
* patients will be divided into 2 groups one will be subjected to intraocular lens (IOL) calculation by optical biometry the second one will be subjected to intraocular lens (IOL) calculation by ultrasonic biometry
* postoperative auto refraction after I month

Eligibility criteria: Inclusion Criteria:

* patients with simple cataract not associated with other pathologies suitable for phacoemulsification and 1ry IOL implantation With axial length (AXL) equal to or greater than 26.5mm

Exclusion Criteria:

1. History of trauma
2. Associated pathologies such as optic neuropathy, age related macular degeneration, macular edema, retinal detachment, , ocular inflammation, retinitis pigmentosa, proliferative diabetic retinopathy
3. corneal opacities or irregularities, scars, dystrophy or ectasia
4. Patients who underwent previous corneal surgery (including refractive surgery)
5. Patients having intraoperative complications as inability to achieve secure 'in the bag' placement of the IOL (i.e. due to posterior capsule rupture, vitreous loss, weak zonules, or zonular rupture)

Primary outcomes:
measure: desired post operative refraction
timeFrame: postoperative refraction 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tappeiner C, Rohrer K, Frueh BE, Waelti R, Goldblum D. Clinical comparison of biometry using the non-contact optical low coherence reflectometer (Lenstar LS 900) and contact ultrasound biometer (Tomey AL-3000) in cataract eyes. Br J Ophthalmol. 2010 May;94(5):666-7. doi: 10.1136/bjo.2009.167700. No abstract available.
citation: Wang L, Shirayama M, Ma XJ, Kohnen T, Koch DD. Optimizing intraocular lens power calculations in eyes with axial lengths above 25.0 mm. J Cataract Refract Surg. 2011 Nov;37(11):2018-27. doi: 10.1016/j.jcrs.2011.05.042.
citation: Olsen T. Improved accuracy of intraocular lens power calculation with the Zeiss IOLMaster. Acta Ophthalmol Scand. 2007 Feb;85(1):84-7. doi: 10.1111/j.1600-0420.2006.00774.x.