louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05751252: Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS.
Official title: Short-term GnRH- Antagonist Treatment to Lower LH Pulsatility in Women With PCOS Aiming to Improve Hormonal Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
GnRH antagonist
LH
androgen
testosterone
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The clinical study using a sub-therapeutic dose of a GnRH antagonist to reduce overactive LH pulsatility in women with PCOS. With the intervention and lowered LH action we anticipate to decrease androgen levels in women with PCOS. The aim to show for the first time that low-dose GnRH-antagonists can lower LH pulsatility by 20-30% and decrease androgen levels without blunting the hypothalamic-pituitary-gonadal axis and thereby the reproductive functions.


Eligibility criteria: Inclusion Criteria:

* Minimum weight of 51 kg
* BMI between 20 and 25
* women with PCOS with AMH\> 28 pmol / L, LH\> 8 IU / mL and testosteronemia \> 0.39 ng/mL
* no hormonal treatment or contraception for 2 months
* women covered by the Social Security system

Exclusion Criteria:

* hormonal treatment or hormonal contraception
* Metformin treatment
* pregnant woman
* inability to understand the newsletter

Primary outcomes:
measure: Serum LH level
timeFrame: every 10 minutes for 8 hours
Secondary outcomes:
measure: Variation in LH secretion amplitude before and after Ganirelix* injection (area under the curve)
timeFrame: at the beginning and at the end of the 8 hours
measure: Variation in androgen production
timeFrame: at 4 hours after injection
measure: change in FSH levels
timeFrame: at 4 hours post-injection
measure: change in estradiol levels
timeFrame: at 4 hours post-injection
measure: change in AMH levels
timeFrame: at 4 hours post-injection
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandre
Study officials:
affiliation: University Hospital, Lille
name: Sophie Catteau-Jonard, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06338852: Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse
Official title: Awareness of Gynaecologists About Role of Physical Therapy in Genital Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Prolapse
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-04-01
Enrollment: 370
Sex: ALL
Minimum age (years): 29
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: They will be selected from outpatient clinic of (Cairo gynaecological Hospitals).

Brief summary: The aim of this study will be to detect if there is awareness of gynecologists about the role of physical therapy in genital prolapse.

Physical therapy plays an important role in assessment, prevention and treatment of pelvic floor dysfunction and genital prolapse, it helps to stimulate and strength pelvic floor muscle.

Physical therapy treatments for the pelvic floor may include bladder training, pelvic floor muscles training with or without biofeedback, vaginal cones, electro stimulation or other adjuncts to training.


Eligibility criteria: Inclusion Criteria:

-

Gynaecologists in private and government hospitals in Egypt

Exclusion Criteria:

* Gynaecologists with less than 5years experience.

Primary outcomes:
measure: Socio demographic and evaluation questionnaires
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy cairo university
Study officials:
References:
Clinical trial NCT01607632: Loving-kindness Meditation for Posttraumatic Stress Disorder (PTSD)
Official title: An Open Pilot Study of Loving-Kindness Meditation for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress
depression
Lead sponsor: Seattle Institute for Biomedical and Clinical Research
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 42
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: A before and after study of veterans who took part in a 12-week loving-kindness meditation course as an adjunct to their usual care for posttraumatic stress disorder.


Eligibility criteria: Inclusion Criteria:

* posttraumatic stress disorder

Exclusion Criteria:

* psychosis
* borderline personality disorder

Primary outcomes:
measure: change in PTSD symptoms
timeFrame: baseline, post-intervention, 3-month follow-up
measure: change in depressive symptoms
timeFrame: baseline, post-intervention, 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound
state: Washington
Study officials:
affiliation: VA Puget Sound
name: David Kearney, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01424852: Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
Official title: Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dental Caries
Keywords: Probiotics
Caries
Oral flora
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2011-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.

Hypothesis: the administration of probiotics during infancy has no effect on future dental health.


Eligibility criteria: Inclusion Criteria:

* Child participated in the probiotic milk intervention study in early 2000
* Child lives now within 100 km from Turku

Exclusion Criteria:

* Child has a chronic illness affecting dental health
* Child lives now outside 100 km from Turku

Primary outcomes:
measure: Caries occurence
timeFrame: 10 years
Secondary outcomes:
measure: Oral microbial colonization
timeFrame: 10 years
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku
name: Erika M Isolauri, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01840332: Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
Official title: Method of Endogenous TSH Stimulation in the Follow-up of Differentiated Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Cancer
Keywords: thyroid cancer
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation to test for cancer recurrence. One of the options is to stop L-thyroxin replacement for several weeks. Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients.

Detailed description: The treatment of differentiated thyroid cancer (DCT) includes surgery followed by radioiodine treatment. In the follow-up of patients it is necessary to induce TSH elevation for the measurement of thyreoglobulin and/or total body scanning. There are two principal methods to obtain TSH elevation: 1) injection of recombinant human TSH , and 2) to stop L-thyroxin replacement for several (3-4) weeks. As use of recombinant TSH is rather expensive, this method is not feasible in many countries. The problem with stopping L-thyroxin is development of severe hypothyroidism for several weeks with concomitant symptoms and signs.

Current pilot study aims to induce the necessary TSH elevation by decreasing the L-thyroxin dose. The main hypothesis is that necessary TSH stimulation will be achieved during 4-6 weeks in majority of patients with fixed dose of L-thyroxin. Concomitantly, blood tests and symptoms and signs of hypothyroidism will be obtained to get information about possible deviations during treatment with low dose of thyroxin.

Eligibility criteria: Inclusion Criteria:

* Differentiated thyroid cancer
* treated by thyroidectomy and at least 1 ablation with 131-I \> 5 months ago
* TSH \< 4 imU/L

Exclusion Criteria:

* Pregnancy
* Known metastasis

Primary outcomes:
measure: TSH level at the end of study
timeFrame: 4-6 weeks
Secondary outcomes:
measure: change in Billewitz index during the study
timeFrame: 4-6 weeks
Other outcomes:
measure: change in biochemical parameters during the study
timeFrame: 4-6 weeks
Locations:
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: Tartu University
name: Vallo Volke, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01714232: Evaluation of Blood Glucose Meter Systems
Official title: Evaluation of Blood Glucose Meter Systems - Contour® PLUS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Detailed description: The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems were evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy

Primary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
timeFrame: 8 hours
Secondary outcomes:
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
timeFrame: 8 hours
measure: MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Mishawaka
country: United States
facility: Bayer HealthCare LLC, Diabetes Care
state: Indiana
Study officials:
affiliation: Ascensia Diabetes Care
name: David Simmons, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pardo S, Dunne N, Simmons DA. A comparison of bolus insulin dose errors based on results of a clinical trial of five blood glucose monitoring systems. Ther Deliv. 2019 Dec;10(12):793-799. doi: 10.4155/tde-2019-0047. Epub 2019 Dec 2.
citation: Dunne N, Viggiani MT, Pardo S, Robinson C, Parkes JL. Accuracy Evaluation of CONTOUR((R))PLUS Compared With Four Blood Glucose Monitoring Systems. Diabetes Ther. 2015 Sep;6(3):377-88. doi: 10.1007/s13300-015-0121-3. Epub 2015 Jul 14.
Clinical trial NCT01489852: Estrogen Pretreatment Prior to GnRH Antagonist Protocol
Official title: Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: Assisted reproductive treatment
GnRH antagonist
Estrogen pre-treatment
Ovarian stimulation
Lead sponsor: Gemer
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 472
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether estrogen pre-treatment can allow retrieval of 2 additional oocytes in GnRH antagonist protocol.


Eligibility criteria: Inclusion Criteria:

* regular normo-ovulatory cycles (28 to 35 days)
* age \< 38 years,
* body mass index (BMI) between 18 and 30
* first or second IVF/ICSI attempt

Exclusion Criteria:

* high basal levels of serum FSH or E2,
* less than 5 follicles at the antral follicular count performed on day 3 of a spontaneous cycle,
* history of high (\>20 oocytes) or low (\< 5 oocytes) ovarian response in a previous IVF attempt

Primary outcomes:
measure: number of retrieved oocytes
timeFrame: at the ovarian puncture, 36 hours post HCG administration
Secondary outcomes:
measure: pregnancy rate
timeFrame: at pregnancy test and at 6 Week US examination
measure: delivery rate
timeFrame: 9 months later
measure: number of obtained embryos
timeFrame: 2 days after in vitro fertilization
measure: duration of FSH administration
timeFrame: at the end of ovarian stimulation usually after a mean of 12 days of administration
measure: Total FSH dose
timeFrame: at the end of ovarian stimulation usually after a mean of 12 days of administration
Other outcomes:
Locations:
city: Bondy
country: France
facility: Service de Medecine de la Reproduction, Hôpital Jean Verdier
state: Ile de France
Study officials:
affiliation: Hôpital Jean Verdier
name: Jean Noel Hugues, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Jean Verdier
name: Isabelle cedrin-durnerin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cedrin-Durnerin I, Guivarc'h-Leveque A, Hugues JN; Groupe d'Etude en Medecine et Endocrinologie de la Reproduction. Pretreatment with estrogen does not affect IVF-ICSI cycle outcome compared with no pretreatment in GnRH antagonist protocol: a prospective randomized trial. Fertil Steril. 2012 Jun;97(6):1359-64.e1. doi: 10.1016/j.fertnstert.2012.02.028. Epub 2012 Mar 28.
Clinical trial NCT01653652: Effect of a Probiotic on Seasonal Allergic Rhinitis Symptoms
Official title: Mitigation of Seasonal Allergic Rhinitis Symptoms in Adults by Probiotic Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Allergic Rhinitis
Keywords: grass pollen
allergic rhinitis
TNSS
miniRQLQ
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2012-07-31
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study is to evaluate the efficacy of administering a probiotic in adult human subjects suffering from allergic rhinitis during seasonal grass pollen exposure.

Detailed description: Adult subjects with documented seasonal allergic rhinitis (SAR) to grass pollen will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 8 weeks during the grass pollen allergy season. Total nasal symptom score (TNSS) will be compared over 8 weeks between the two treatment groups.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65 years of age at the time of enrolment.
* Established seasonal allergic rhinitis (clinical history of rhinorrhea, congestion, sneezing, pruritis \>2 years)
* Positive Skin Prick Test (SPT)to Grass Pollen (GP).
* Presence of specific IgE to Grass Pollen (GP)
* Have a Body Mass Index in the range 19-32 kg/m2
* Have signed the consent form
* Have been instructed during screening and agreed to not take any probiotic containing products outside the study for the study period

Exclusion Criteria:

* Subjects currently under treatment with antibiotics or undergoing allergen immunotherapy at the time of enrolment
* Pregnancy
* Vasomotor rhinitis, nasal cavity disorders (nasal polyps), ear infections otitis media).
* Other chronic diseases (e.g. gastrointestinal, cardiovascular, infections)
* Subjects diagnosed with asthma
* Subjects currently participating in another interventional clinical trial or having participated in another clinical trial in the last 2 months
* Subjects on chronic use of systemic corticosteroids prior to randomization

Primary outcomes:
measure: Total nasal symptom score (TNSS)
timeFrame: every day over 8 weeks
Secondary outcomes:
measure: Total ocular symptom score (TOSS)
timeFrame: every day over 8 weeks
measure: miniRQLQ
timeFrame: every week for 8 weeks
measure: Individual nasal and ocular symptoms scores
timeFrame: every day over 8 weeks
measure: Well being index
timeFrame: every week over 8 weeks
measure: Medication Score
timeFrame: every week over 8 weeks
measure: Specific IgE
timeFrame: Baseline and end of study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References:
Clinical trial NCT03165032: Right Ventricular Function During Exercise in Highlanders/Lowlanders
Official title: Right Ventricular Function During Exercise in Highlanders With Pulmonary Hypertension Compared to Highlanders Without Pulmonary Hypertension and Lowlanders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Altitude Pulmonary Hypertension
Keywords: exercise
echocardiography
right ventricular function
pulmonary hypertension
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-05-24
Enrollment: 173
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \<1000 m.

Brief summary: The purpose of the current study is to evaluate the right ventricular function during graded cycling on an ergometer by transthoracic echocardiography in Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a cross-sectional case-control study.


Eligibility criteria: Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion Criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* Excessive erythrocytosis
* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* Regular use of medication that affects control of breathing
* Heavy smoking

Primary outcomes:
measure: pulmonary artery pressure (PAP) during exercise
timeFrame: Day 2
Secondary outcomes:
measure: cardiac output (CO) during exercise
timeFrame: Day 2
measure: PAP/CO slope during exercise
timeFrame: Day 2
measure: Oxygen saturation
timeFrame: Day 2
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
References: