louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04607252: Metformin Plus Megestrol Acetate As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
Official title: Comparing Metformin Plus Megestrol Acetate with Megestrol Acetate Alone As a Fertility-sparing Treatment in Patients with Atypical Endometrial Hyperplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Atypical Endometrial Hyperplasia
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH).

Detailed description: Whether metformin could improve the effect of progestin as fertility-sparing treatment in patients with atypical endometrial hyperplasia(AEH) is still not clear. Our previous finding from subgroup analysis in a phase II randomized controlled trial showed that 39.6% of AEH patients in metformin plus megestrol acetate group achieved complete response, compared with 20.4% in group of megestrol acetate alone. This trial aim to fully testify the effect of metformin in fertility-sparing treatment for AEH patients with adequate sample size.

Eligibility criteria: Inclusion Criteria:

1. 18-45 years old;
2. pathologically diagnosed with AEH for the first time;
3. desire to preserve their fertility;
4. no signs of suspicious myometrial invasion or extrauterine metastasis by enhanced magnetic resonance imaging (MRI), enhanced computed tomography (CT) or transvaginal ultrasonography (TVUS);
5. no contraindication for metformin, megestrol acetate or pregnancy;
6. no hormone or metformin treatment within 6 months before entering the trial;
7. not pregnant when participating in the trial;
8. willing to follow the trial arrangement after being fully informed of all the risks and inconveniences caused by the trial.

Exclusion Criteria:

Patients who had one or more of the following conditions:

1. allergy history or contraindications for megestrol acetate or metformin;
2. pregnant when initiating the study;
3. alcoholism, severe infection, severe chronical diseases (dysfunction of heart, liver, lung or kidney);
4. high risk of thrombosis;
5. recurrent AEH;
6. endometrial cancer;
7. other malignancy history.

Primary outcomes:
measure: Complete response within 16 weeks of treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Complete response within 32 weeks of treatment
timeFrame: 32 weeks
measure: Adverse events
timeFrame: 32 weeks
measure: 2-year recurrence rate
timeFrame: 2 years
measure: 2-year pregnancy rate
timeFrame: 2 years
measure: 2-year live-birth rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Obstetrics & Gynecology Hospital of Fudan University
name: Xiaojun Chen, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00803452: Lipids of the Human Tear Film and Their Effect on Tear Stability
Official title: Lipids of the Human Tear Film and Their Effect on Tear Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Keywords: Meibomian gland dysfunction
Lid margin disease
doxycycline
azithromycin
essential fatty acid
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, comparative clinical trial evaluates the effect of either oral doxycycline, oral essential fatty acid, or topical azithromycin to modify the secretions of the meibomian gland in subjects with meibomian gland dysfunction and/or dry eye disease.

Detailed description: Subjects with meibomian gland dysfunction undergo expression of the meibomian gland secretion prior to beginning treatment with either oral doxycycline or topical azithromycin solution. Doxycycline is dosed at 100 mg bid; topical azithromycin is delivered once per day as a 1% solution. Treatment with doxycycline is for two months; treatment with topical azithromycin is for one month. Following treatment, meibomian glands are again expressed and the lipids measured by spectroscopy (FTIR, MALDI-TOF, NMR)for characterization of structure and function. Analysis for presence of doxcycline or azithromycin is also performed. Changes in lipid parameters are correlated with clinical signs and symptoms of disease.

Eligibility criteria: Inclusion Criteria:

* Meibomian gland dysfunction

Exclusion Criteria:

* Lid margin scarring; herpetic blepharitis

Primary outcomes:
measure: Global Response to Therapy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentucky Lions Eye Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Gary N Foulks, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foulks GN, Borchman D, Yappert M, Kakar S. Topical azithromycin and oral doxycycline therapy of meibomian gland dysfunction: a comparative clinical and spectroscopic pilot study. Cornea. 2013 Jan;32(1):44-53. doi: 10.1097/ICO.0b013e318254205f.
citation: Foulks GN, Borchman D, Yappert M, Kim SH, McKay JW. Topical azithromycin therapy for meibomian gland dysfunction: clinical response and lipid alterations. Cornea. 2010 Jul;29(7):781-8. doi: 10.1097/ICO.0b013e3181cda38f.
citation: Borchman D, Foulks GN, Yappert MC, Bell J, Wells E, Neravetla S, Greenstone V. Human meibum lipid conformation and thermodynamic changes with meibomian-gland dysfunction. Invest Ophthalmol Vis Sci. 2011 Jun 1;52(6):3805-17. doi: 10.1167/iovs.10-6514.
Clinical trial NCT05783752: Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses
Official title: Effects of Stair Stepping on Late Day Postprandial Glycemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postprandial Glycemic Response
Postprandial Hyperglycemia
Postprandial Insulin
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test whether one minute of stair stepping at a comfortable pace can reduce blood sugar after meals. The main objectives of the study are:

Compare continuously measured post-meal glucose after stair-stepping to control condition Compare continuously measured post-meal glucose after stair-stepping between meals Assess interaction between condition and meal to determine if the effect of stair-stepping on post-meal glucose depends on meal

Participants will be in the study for 10 days and will be asked to:

Wear a continuous glucose monitor over the course of the study Perform either one minute of comfortable pace stair stepping 15 min after each meal OR no exercise 1 hour after eating a meal on alternating days Perform a dietary recall every two days Perform no exercise within one hour after each meal on any day during the study Consume no calories within one hour after each meal during the study

Detailed description: After being informed about the study and potential risks, all participants giving written informed consent will undergo a screening to determine eligibility for study entry. At day 1, patients who meet the eligibility requirements will be randomly assigned to Arm 1(stair stepping day followed by no exercise day sequence) or Arm 2(no exercise day followed by stair stepping day sequence). At this time participants will also be familiarized with the continuous glucose (i.e., blood sugar) monitor they will wear for ten days, be instructed how to fill out a food log every day and determine a comfortable stair stepping pace. On day 10 participants will return to the lab for sensor removal and transmitter return.

Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years
* able to climb and descend stairs
* access to stairs

Exclusion Criteria:

* glycemic medications that vary in dosage
* dosage from meal to meal or day to day (eg insulin titrated to meal size or carbohydrate content)

Primary outcomes:
measure: Postprandial Blood Glucose
timeFrame: continuous measure from meal consumption up to 1 hour post meal
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT01162252: Improving Psoriasis Through Health and Well-Being
Official title: Improving Psoriasis Through Health and Well-Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psoriasis
Keywords: psoriasis
mindfulness
MBSR
stress
living well
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2010-07-14
Enrollment: 130
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 the study is to examine and compare the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well (LW) program on adults with psoriasis in terms of how these programs may affect their psoriasis, immune function, physical and emotional health, and well-being.

Detailed description: The study examines the effects of two eight-week programs (MBSR vs. LW) for disease processes in patients with psoriasis severity reporting moderate or higher perceived stress. The research will focus both on clinical measures of the disease state and overall well-being.

The Aims of our proposed intervention study are the following:

1. To examine the effects of MBSR, versus the Living Well (LW) program, on (a) disease severity, immunological markers of inflammation, and keratinocyte proliferation, (b) psoriasis-related stress and perceived stress in general, and (c) anxiety and depression.
2. To examine whether treatment effects of either program are moderated by personality traits, mindfulness, and age.
3. To examine the effects of behavioral and psychological mediators on immune outcomes.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* English speaking
* Clinical diagnosis of psoriasis (active at initial visit)

Exclusion Criteria:

* currently receiving immunosuppressive therapy for cancer or for diseases unrelated to psoriasis (or \< 6 months post-chemo or radiation)
* major, uncorrected sensory impairments
* cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
* severe cardiovascular disease
* current alcohol abuse or non-alcohol psychoactive substance use disorders, psychotic disorders (current and lifetime), and current mood disorder with psychotic features.

Primary outcomes:
measure: Psoriasis disease severity measured from biopsied tissue samples of psoriatic and nonpsoriatic skin.
timeFrame: 8 weeks
Secondary outcomes:
measure: Immunological markers of inflammation measured from blood samples.
timeFrame: 16 weeks
measure: Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983))
timeFrame: 16 weeks
measure: State-Trait Anxiety Inventory (Spielberger C.D., Gorsuch R.L., & Lushene R.E. (1970))
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester; University Dermatology Associates
state: New York
Study officials:
affiliation: University of Rochester
name: Jan A Moynihan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02497352: Effects of Flaxseed Supplementation in Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2015-07-14
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of flaxseed supplementation on fasting blood sugar, lipid profile and anthropocentric measurements in subjects with metabolic syndrome, in a randomized, open-labeled, controlled pilot study, 44 subjects with metabolic syndrome will be received 30g/d flaxseed with lifestyle modification or lifestyle modification alone for 12 weeks. Both groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome will be measured at the baseline and at the end of the study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report

Exclusion Criteria:

* history of allergy or high consumption of nuts, flaxseed, or sesame seeds
* clinically diagnosed renal, liver, heart, pituitary, thyroid, or psychiatric disorders impairing the patient's ability to provide written informed consent
* history of cardiovascular diseases, cancers, alimentary tract disorders affecting absorption
* pregnancy, lactation, and lack of effective birth control in women of child-bearing potential

Primary outcomes:
measure: Insulin resistance index (HOMA-IR)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01121952: The Effect of Manipulation on Dysfunction of the Talo-crural Joint
Official title: The Effect of Manipulation on Dysfunction of the Talo-crural Joint- a Clinical Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Biomechanical Lesions
Talo-crural Joint Dysfunction
Keywords: Ankle joint
Talo-crural joint
Vertical jump
Chiropractic manipulation (HVLA)
ROM
Proprioception
Pain
Lead sponsor: Scandinavian College of Chiropractic
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 19
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial was to explore the effects of chiropractic manipulation in patients with talo-crural joint dysfunction.

Detailed description: Ankle sprains is one of the most common problems in clinical practice, mostly due to loss of mobility. Factors affecting the mobility of the joints may be due to muscle tension, ligamentous or anatomical anomalies.

Research over the last years have reported a scarce of trials investigating chiropractic treatment of the ankle joint. Previous studies have focused on investigating ROM and proprioception. This study aimed to determine whether a single high-velocity, low-amplitude (HVLA) thrust manipulation to the talo-crural joint altered ankle function in subjects with dysfunction of the talo-crural joint.

Eligibility criteria: Inclusion Criteria:

* First league handball player
* Talo-crural joint dysfunction
* Age \>16 yrs

Exclusion Criteria:

* Patients with a history of recent trauma or previous operations with remaining fixation material in the foot or ankle

Primary outcomes:
measure: Counter movement jump; IVAR test system
timeFrame: Day 1
Secondary outcomes:
measure: Counter movement jump; IVAR test system
timeFrame: Week one
measure: Counter movement jump; IVAR test system
timeFrame: Week two
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Scandinavian College of Chiropractic
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Håkan A Westerblad, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00221052: Effect of Reduction of Inflammatory Status on Glucose Metabolism in Overweight Men
Official title: Relation Between Reduction of the Inflammatory Status and Glucose Metabolism in Healthy Overweight Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Inflammation
Lead sponsor: TNO
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Overweight increases the risk to develop chronic diseases including type-2 diabetes and cardiovascular disease. The low-grade inflammatory status often seen in overweight subjects is thought to play an important role in disease development.

The purpose of this study is to determine the role of inflammation on glucose metabolism and insulin resistance. In this study the effect of the anti-inflammatory treatment diclofenac on markers of inflammation and on parameters of glucose metabolism will be studied.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI): 25.1 - 32.0 kg/m2
* Normal Dutch eating habits

Exclusion Criteria:

* diabetes, cardiovascular disease or hypertension
* Not suitable to receive diclofenac treatment
* Smoking
* Extreme physical activity (more than 6 hours/week)
* Reported slimming or medically prescribed diet

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zeist
country: Netherlands
facility: TNO Quality of Life
Study officials:
affiliation: TNO Quality of Life, Location Zeist
name: Trinette van Vliet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Erk MJ, Wopereis S, Rubingh C, van Vliet T, Verheij E, Cnubben NH, Pedersen TL, Newman JW, Smilde AK, van der Greef J, Hendriks HF, van Ommen B. Insight in modulation of inflammation in response to diclofenac intervention: a human intervention study. BMC Med Genomics. 2010 Feb 23;3:5. doi: 10.1186/1755-8794-3-5.
Clinical trial NCT00959452: Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007
Official title: Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypochondriasis
Keywords: Hypochondria
Cognitive behavioural therapy
Long term follow-up
Psychosomatics
Psychotherapy
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2009-08-14
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). In another part of the study (Part II) the investigators compare the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The investigators hypothesis is that the initial 1 year improvement will be sustained and that 5 sessions will yield the same results as 16 sessions.

Detailed description: The follow-up includes a telephone interview by independent researcher and the patients fill in the following questionnaires:

Whiteley Index (measures health anxiety), VAS-scales for health anxiety, worrying about symptoms and body checking, SF-36 (health related quality of life), Giessen Subjective Complaints List, Spielberger Trait and State Anxiety Scale Beck Depression Inventory, Eysenck Personality Questionnaire, General Health Questionnaire (GHQ 28), Somatic Amplification Scale,

Eligibility criteria: Inclusion Criteria:

* Fulfilling ICD-10 criteria for hypochondriacal disorder

Exclusion Criteria:

* Unwillingness to participate
* Substance abuse
* Serious psychological (f.inst. psychosis, major depression) or somatic (f.inst. cancer) disease

Primary outcomes:
measure: Level of health anxiety
timeFrame: 10 years follow up
Secondary outcomes:
measure: Health related quality of life
timeFrame: 10 years follow-up
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haraldsplass Deaconal Hospital
Study officials:
affiliation: University of Bergen
name: Ingvard Wilhelmsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veddegjaerde KE, Sivertsen B, Wilhelmsen I, Skogen JC. Confirmatory factor analysis and item response theory analysis of the Whiteley Index. Results from a large population based study in Norway. The Hordaland Health Study (HUSK). J Psychosom Res. 2014 Sep;77(3):213-8. doi: 10.1016/j.jpsychores.2014.06.011. Epub 2014 Jun 28.
citation: Veddegjaerde KF, Sivertsen B, Skogen JC, Smith ORF, Wilhelmsen I. Long-term effect of cognitive-behavioural therapy in patients with Hypochondriacal Disorder. BJPsych Open. 2020 Apr 29;6(3):e42. doi: 10.1192/bjo.2020.22.
Clinical trial NCT01214252: A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Defects
Keywords: Repair of patients' abdominal wall defects
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-10-05
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone surgical repair of their abdominal wall defects with Permacol Surgical Implants with at least 12 months(-30days)follow-up

Brief summary: To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.


Eligibility criteria: Inclusion Criteria:

* Equal or over 18 years of age
* Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
* At least 12 months of follow-up post date of surgery (-30 days)
* Undergone open or laparoscopic repairs

Exclusion Criteria:

* Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
* Any prior use of Permacol in abdominal wall repair

Primary outcomes:
measure: Confirmed Hernia Recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Total Unconfirmed Hernia or Hernia Recurrence
timeFrame: 12 Months
measure: Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed
timeFrame: Year 2 to Year 8
Other outcomes:
Locations:
city: Bedford
country: United States
facility: Annie Choi
state: Massachusetts
Study officials:
References:
citation: Chand B, Indeck M, Needleman B, Finnegan M, Van Sickle KR, Ystgaard B, Gossetti F, Pullan RD, Giordano P, McKinley A. A retrospective study evaluating the use of Permacol surgical implant in incisional and ventral hernia repair. Int J Surg. 2014;12(4):296-303. doi: 10.1016/j.ijsu.2014.01.025. Epub 2014 Feb 5.