louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03055442: Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid
Official title: Altered Myo-inositol/D-chiro-inositol Ratio in Follicular Fluid of Women Undergoing in Vitro Fertilization Has Detrimental Effects on Oocyte and Embryo Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Women Infertility
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2017-02-16
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 8 egg donors participating in the donation program of IAKENTRO not for the first time, and 11 recipient couples undergoing in vitro fertilization (ICSI).

Follicular fluid (FF) specimens were analysed.

Brief summary: Considering the importance assumed by follicular microenvironment for a proper oocyte development, this study is a prospective observational clinical trial which aims to evaluate whether the embryo blastocyst quality may be affected by different Myo-inositol (MI) and D-chiro-inositol (DCI) levels in the follicular fluid (FF) of the aspired oocytes. The study includes egg donors and egg receiving couples participating in the oocyte donation program. MI/DCI is calculated in FF and related with blastocyst grade.


Eligibility criteria: Inclusion Criteria:

* clear follicular aspirate obtained during oocyte retrieval;
* each specimen of follicular fluid containing only one oocyte.

Exclusion Criteria:

* hyperglycaemic women;
* PCOS women also if euglycaemic;
* diabetic subjects having low concentrations of detectable MI in association with an anomalous MI transport.

Primary outcomes:
measure: Myo-inositol concentration (µmol/l) in follicular fluid
timeFrame: 5th day from pick up
measure: D-chiro-inositol concentration (µmol/l) in follicular fluid
timeFrame: 5th day from pick up
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Iakentro Advanced Medical Centre, IVF Unit
Study officials:
References:
citation: Chiu TT, Rogers MS, Law EL, Briton-Jones CM, Cheung LP, Haines CJ. Follicular fluid and serum concentrations of myo-inositol in patients undergoing IVF: relationship with oocyte quality. Hum Reprod. 2002 Jun;17(6):1591-6. doi: 10.1093/humrep/17.6.1591.
citation: Carlomagno G, Unfer V, Roseff S. The D-chiro-inositol paradox in the ovary. Fertil Steril. 2011 Jun 30;95(8):2515-6. doi: 10.1016/j.fertnstert.2011.05.027. Epub 2011 Jun 8.
citation: Gardner DK, Lane M, Stevens J, Schlenker T, Schoolcraft WB. Blastocyst score affects implantation and pregnancy outcome: towards a single blastocyst transfer. Fertil Steril. 2000 Jun;73(6):1155-8. doi: 10.1016/s0015-0282(00)00518-5.
citation: Ravanos K, Monastra G, Pavlidou T, Goudakou M, Prapas N. Can high levels of D-chiro-inositol in follicular fluid exert detrimental effects on blastocyst quality? Eur Rev Med Pharmacol Sci. 2017 Dec;21(23):5491-5498. doi: 10.26355/eurrev_201712_13940.
Clinical trial NCT03578042: Fixed-Free HTN Trial
Official title: Effect of Fixed Triple Combination With Losartan-Amlodipin-HCTZ vs. Free Triple Combination on Blood Pressure Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Hotel Dieu de France Hospital
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the effect of FIXED triple anti-hypertensive therapy with losartan-amlodipin-HCTZ vs any free triple combination therapy chosen by the treating physician for patients with uncontrolled hypertension

Detailed description: Patients who have uncontrolled hypertension and who require triple therapy will be randomized to receive:

1. Fixed combination containing 3 anti-hypertensive drugs: losartan 100 mg + amlodipin 5 mg + hydrocholorothiazide 12.5 mg one tab/day
2. Or any other therapy decided by the treating physician containing three anti-hypertensive agents but supplied as "free" therapy, meaning supplied as 2 or 3 separate tablets Patients will have a baseline ambulatory blood pressure recording. The same recording will be repeated at 2 months of therapy.

We expect fixed triple combination to be more effective because the drugs used work synergistically together and the compliance will be higher

Eligibility criteria: Inclusion Criteria:

* Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled\* Or patients on monotherapy and who have a BP \> 160/100 mm Hg

  * BP is defined as UNCONTROLLED if \> 135/85 at home or \> 140/90 in clinic on at least 2 occasions

Exclusion Criteria:

* Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction \< 3 months old Permanent atrial fibrillation Ejection fraction \< 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with \> 3 drugs

Primary outcomes:
measure: average 24 hour blood pressure measured by ambulatory recording
timeFrame: measured after 2 months of therapy
Secondary outcomes:
measure: central aortic blood pressure
timeFrame: measured after 2 months of therapy
measure: pulse wave velocity
timeFrame: measured after 2 months of therapy
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
Study officials:
affiliation: Hotel Dieu de France Hospital
name: Rabih R Azar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06600542: Inari VISION Registry
Official title: Inari VISION Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been treated with an Inari Medical device.

Brief summary: This registry is a global prospective, non-randomized, multicenter, observational, active post-market data collection of Inari Medical devices and products.


Eligibility criteria: Inclusion Criteria:

1. Willing and able to provide informed consent per institution and geographical requirements
2. Has received treatment with an eligible Inari Medical device. NOTE: If patients are consented prior to their procedure and the procedure does not take place, the patient will be considered a screen failure.
3. Currently within enrollment window relative to their procedure
4. Age ≥ 18 years

Exclusion Criteria:

1. Is or will be inaccessible for registry follow-up
2. Meets exclusion criteria required by local requirements
3. Current or planned participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this registry
4. Is pregnant or breastfeeding at the time of enrollment

Primary outcomes:
measure: Incidence of device-related, procedure-related, or fatal Adverse Events
timeFrame: Up to 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: UCLH University College London Hospital
Study officials:
References:
Clinical trial NCT00859742: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration (EBUS-TBNA) for Mediastinal Re-staging of Non-small Cell Lung Cancer(NSCLC)
Official title: Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-staging After Induction Therapy in Non-small Cell Lung Cancer. A Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2009-03-11
Enrollment: 0
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 aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer.

Primary objective:

1. To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment.

Secondary objectives:

1. To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
2. To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
3. To determine procedure related complications


Eligibility criteria: Inclusion Criteria:

* Histologically proven non-small cell lung cancer
* Patients who have initially histologically proven N2 disease (Stage IIIA)
* Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
* Written informed consent

Exclusion Criteria:

* Contraindications for bronchoscopy
* Medically inoperable patients
* Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment

Primary outcomes:
measure: The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
timeFrame: 1.5 years
Secondary outcomes:
measure: The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer
timeFrame: 1.5 years
measure: The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: NCCKorea
state: Gyeonggi-do
Study officials:
affiliation: Goyang, Gyeonggi-do, Korea, Republic of
name: Bin Hwangbo, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00996242: An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
Official title: An Exploratory Open Label Study of Adjunctive L-lysine Treatment in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia
L-lysine
PANSS
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2009-10-16
Enrollment: 10
Sex: ALL
Minimum age (years): 23
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the present study was to investigate the possibility of using L-lysine, an amino acid that occurs naturally in food and which interferes with nitric oxide (NO) production, for the treatment of schizophrenia. L-lysine, 6 g/day, was administered to ten patients with schizophrenia as an add-on treatment to conventional antipsychotic treatment. The study was designed as a single-blinded, cross-over study where patients were randomly assigned to initial treatment with either L-lysine or placebo and screened at baseline, after four weeks when treatment was crossed over, and after eight weeks when treatment was terminated. The four-week L-lysine treatment regimen caused a significant increased in blood concentration of the amino acid and was tolerated well. The analysis of outcome measures showed a significant decrease in symptom severity as measured by the Positive and Negative Syndrome Scale (PANSS). Furthermore, the patient's ability to solve the Wisconsin Card Sorting Task (WCST) was significantly improved indicating increased problem solving capacity and cognitive flexibility. Subjective reports from three of the patients also indicated decreased symptom severity and enhanced cognitive functioning. In summary, these findings suggest potential beneficial effects of L-lysine treatment on symptom severity and cognitive deficits in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* a stable phase of illness
* a stable dose of antipsychotic medication
* no other major medical conditions or other psychiatric diagnosis
* normal admission laboratory tests and vital signs

Exclusion Criteria:

* substance abuse, apart from smoking

Primary outcomes:
measure: Psychotic symptoms severity
timeFrame: Eight weeks
Secondary outcomes:
measure: Treatment safety assessment
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska Univeristy Hospital
Study officials:
References:
citation: Wass C, Klamer D, Katsarogiannis E, Palsson E, Svensson L, Fejgin K, Bogren IB, Engel JA, Rembeck B. L-lysine as adjunctive treatment in patients with schizophrenia: a single-blinded, randomized, cross-over pilot study. BMC Med. 2011 Apr 18;9:40. doi: 10.1186/1741-7015-9-40.
Clinical trial NCT06356142: The Effects of Palmar Cooling on Repeated Sprinting Ability
Official title: The Effects of Palmar Cooling on Repeated Sprinting Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Exercise Induced Fatigue
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Repeated sprinting ability is key for athletic performance in a variety of sport settings. Significant degradations in work output (i.e. fatigue) have been shown to develop after just one sprinting bout1. This pilot study aims to investigate the effects that noninvasive transient temperature manipulation has on an individual's ability to perform repeated sprints. The investigators aim to enroll 90 healthy individuals, 18-30 years of age. Participants will be randomized into two groups (Group A, and B). All groups will perform a ten-minute warm-up followed by two minutes of rest. Following the warm-up and rest period, all groups will participate in a series of five sprints, 60 meters in total length with two 180 degree changes in direction. Between sprints, participants will have 10 seconds rest. After the first series of five sprints participants will be given a 2-minute rest interval. Then participants will perform another series of five sprints followed by another 2-minute rest interval. During each rest interval, Group A will utilize a palmar cooling device. Group B will utilize a placebo version of the palmar cooling device. All sprints will be timed. Heart rate recovery will be measured during all rest breaks, and a rating of perceived exertion will be measured at the beginning and end of each resting interval. Delayed onset muscle soreness will be assessed 48 hours post sprinting, utilizing a visual analog scale.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals 18-30 years of age

Exclusion Criteria:

* Participant self-reporting injury or illness that will prevent them from exercising at maximal capacity
* If participant has been told by their healthcare provider that they should avoid exercising at maximal capacity
* Has previously used the palmar cooling device

Primary outcomes:
measure: Participants Sprinting times
timeFrame: 1 day
Secondary outcomes:
measure: Participants Heart Rate Recovery
timeFrame: 1 day
measure: Participants Rating of Perceived exertion
timeFrame: 1 day
measure: Participants Reported Delayed Onset Muscle Soreness
timeFrame: 2 days after the intervention
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
References:
Clinical trial NCT06688942: Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease
Official title: Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Graft-Versus-Host Disease
Quality of Life
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this interventional study is to learn if the Horizons mobile application is feasible for survivors of allogeneic hematopoietic stem cell transplant who have chronic graft-versus-host disease. Participants will be asked to complete surveys and use the Horizons mobile application.


Eligibility criteria: Inclusion Criteria:

* Underwent allogeneic hematopoietic stem cell transplant
* Have moderate to severe chronic graft-versus-host disease
* Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
* Able to use an Ipad to participate in the Horizons app intervention
* Able to participate in study procedures in English

Exclusion Criteria:

* comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
* Vulnerable patients, defined here as prisoners and pregnant women

Primary outcomes:
measure: Percentage of participant enrollment
timeFrame: Up to 8-week follow-up
measure: Percentage of participant retention
timeFrame: Up to 8-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Lara Traeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02192242: Investigating a Model for Acute Ischemic Pain in Humans
Official title: Investigating a Model for Acute Ischemic Pain in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Keywords: acute ischemic pain
model
S100
interleukine 6
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 11
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The pathophysiology of acute ischemic pain is not well established. The aim of the present study was to investigate acute ischemic pain in humans with a view to establish a scientific model to perform future studies. The investigators examined whether peripheral nerve damage and acute inflammation occur during short episodes of acute ischemia.


Eligibility criteria: Inclusion Criteria:

* patients over 40 years
* unilateral femoral-popliteal PAD, Fontaine grade II

Exclusion Criteria:

* patients with pain at rest or other pain origin
* diabetic polyneuropathy
* deep vein thrombosis

Primary outcomes:
measure: Induce acute ischemic pain
timeFrame: during treadmill exercise (less than 15 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: University Hospital Munich, Pettenkoferstr. 8a
Study officials:
affiliation: Department of Anesthesiology, Ludwig-Maximilians-University Munich
name: Philip M Lang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03176342: Drug Patch Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
Official title: Drug Patch Tests, Enzyme-linked Immunosorbent Spot Assay (Elispot) and Lymphocyte Transformation Tests in Patients With Severe Cutaneous Adverse Reaction to Drugs (SCARs)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug Reaction
Keywords: Drug patch tests
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is about drug patch tests in patients who have history of severe cutaneous drug reaction including Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), Drug-induced eosinophilia and systemic symptoms (DRESS), AGEP (Acute generalized exanthematous pustulosis) and generalized bullous fixed drug eruptions. This study also investigate in Enzyme-linked immunosorbent spot assay (ELIspot) and lymphocyte transformation test. We also trying to prove the correlation among result of drug patch tests, ELIspot and LTT.


Eligibility criteria: Inclusion Criteria:

* Patients with history of Steven Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug-induced eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), generalized bullous fixed drug eruption in the past 24 months.
* Age more than 18 years old

Exclusion Criteria:

* Receiving immunosuppressive drugs or more than 10 mg/day of prednisolone within 1 month.
* Pregnancy and lactation

Primary outcomes:
measure: Prevalence of positive drug patch test results.
timeFrame: 3 years
Secondary outcomes:
measure: correlation of drug patch test results, ELIspot and lymphocyte transformation test.
timeFrame: 3 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of Dermatology, Faculty of Medicine, Chulalongkorn University
Study officials:
References: