louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00449514: Tamoxifen Compared With Clomiphene Citrate for Women Who Had Thin Endometrium Women Under Clomiphene in a Previous Cycle
Official title: Prospective Randomized Study of Ovulation Induction Using Either Tamoxifen or Clomiphene Citrate for Women Who Had Thin Endometrium During Previous Treatment With Clomiphene Citrate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: infertility
ovulation dysfunction
endometrium
tamoxifen
clomiphene citrate
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: About 10-15% of all couples attempting to conceive will not become pregnant within one year. Among those, the majority will have ovulatory dysfunction, mild male infertility or unexplained infertility. The traditional first line therapy for those couples is ovulation induction or superovulation using clomiphene citrate. Probably due to anti-estrogenic effects of this agent will, some patients will have a thin endometrium as measured by sonography at the time of ovulation. This phenomenon may be associated with a lower chance to conceive. Tamoxifen is a similar molecule that has been used to clomiphene citrate that has been shown to be equally effective to clomiphene in ovulation induction. Preliminary observations showed that tamoxifen does not cause a negative effect on the endometrium as compared with clomiphene, and may increase the chance to conceive in those patients who have a thin endometrium under clomiphene.


Eligibility criteria: Inclusion Criteria:

* Primary or secondary infertility due to:
* Ovulatory dysfunction
* Mild male infertility
* Unexplained infertility
* Endometrium \< 6 mm at time of hCG during previous treatment with clomiphene citrate
* Age 18-35

Exclusion Criteria:

* Serious adverse effects under clomiphene citrate or known sensitivity to either tamoxifen or clomiphene citrate

Primary outcomes:
measure: Pregnancy rate
measure: delivery rate
Secondary outcomes:
measure: endometrium thickness
measure: percentage of ovulation
measure: number of follicles
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare-Zedek Medical Center
Study officials:
affiliation: Department of Obstetrics and Gynecology, Shaare-Zedek Medical Center, Jerusalem, Israel
name: Avi Tsafrir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steiner AZ, Terplan M, Paulson RJ. Comparison of tamoxifen and clomiphene citrate for ovulation induction: a meta-analysis. Hum Reprod. 2005 Jun;20(6):1511-5. doi: 10.1093/humrep/deh840. Epub 2005 Apr 21.
Clinical trial NCT02676414: Validation of a Hypertension Education Program
Official title: Validation of the Hypertension Education Program of the German Hypertension League (DHL©) "My Blood Pressure - OK!"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 134
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to assess the effect of participating in the interactive hypertension education program of the German Hypertension League (DHL©) "My blood pressure - OK!" on office systolic blood pressure.


Eligibility criteria: Inclusion Criteria:

* \> 21 years of age
* Primary arterial hypertension
* Office blood pressure between 140/90 mmHg and 160/100 mmHg

Exclusion Criteria:

* Participation in another clinical study
* Unstable clinical condition
* Secondary arterial hypertension
* Dementia
* Major disability (modified Rankin-Scale \> 4)
* Severe chronic kidney disease (serum creatinine \> 2.0 mg/dL or estimated glomerular filtration rate \< 40 ml/min/1.73m2)
* Liver disease including history of hepatic encephalopathy, esophageal varices or portacaval shunt
* History of gastrointestinal operation or disease with a potential influence on drug absorption
* Allergy or other contraindications against drugs given during the study
* History of non-compliance

Primary outcomes:
measure: Office systolic blood pressure (mmHg)
timeFrame: 6 months
Secondary outcomes:
measure: Office diastolic blood pressure (mmHg)
timeFrame: 6 months
measure: Self-measured systolic and diastolic blood pressure (mmHg)
timeFrame: 6 months
measure: 24-hour ambulatory blood pressure monitoring (mmHg)
timeFrame: 6 months
measure: Body Mass Index (kg per m2)
timeFrame: 6 months
measure: Physical activity (hours per week)
timeFrame: 6 months
measure: Alcohol consumption (drinks per week)
timeFrame: 6 months
measure: Quality of life based on the Quality of Life Questionnaire "The Short Form 36 Health Survey"
timeFrame: 6 months
measure: Knowledge regarding arterial hypertension based on the DHL© Questionnaire
timeFrame: 6 months
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Ruhr-Universität Bochum
state: Nordrhein-Westfalen
Study officials:
affiliation: Charite University, Berlin, Germany
name: Reinhold Kreutz, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00908895: Non-bridging Fixator Versus Percutaneous Pinning for Distal Radius Fractures
Official title: Non-bridging Radio-radial Fixator Compared to Percutaneous Pinning for Unstable Distal Radius Fracture. A Prospective Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radius Fractures
Keywords: Radius fractures
Radio-radial fixator
Percutaneous pinning
Grip strength
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2009-05-27
Enrollment: 120
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 treatment of extra-articular distal radius fractures is still controversial. In Canada, most patients with unstable fractures are treated with pinning and cast. Results are often associated with shortening and lack of function.

The purpose of the study is to compare stabilization with a radio-radial fixator to the usual method, suggesting that the radio-radial fixator will provide more strength at 6 months follow-up.


Eligibility criteria: Inclusion Criteria:

* Distal radius fracture Frykman I or II
* Unstable fracture according to Lafontaine's criteria
* Fracture line more than 1cm form the joint line
* Closed fracture
* Age \> 18 years
* Surgery performed between 72 hours from the trauma
* Monotrauma
* Patient signed the informed consent

Exclusion Criteria:

* Distal radius fracture Frykman III-VI (intra-articular fracture)
* Open fracture
* Polytraumatism
* Stable or non-displaced fracture

Primary outcomes:
measure: The Grip Strength
timeFrame: 6 months
Secondary outcomes:
measure: Range of Movement of Wrist
timeFrame: 6 months
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Département d'orthopédie, CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
References:
Clinical trial NCT06523595: Evaluation of the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adults
Official title: A Phase 1, Open-label Study Evaluating the Pharmacokinetic Drug-drug Interactions Between VX-993 and Metformin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2024-07-26
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetic drug-drug interactions, safety, and tolerability of co-administration of VX-993 and metformin in healthy participants.

Detailed description: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility criteria: Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 Kilogram per square meter (kg/m\^2)
* A total body weight of more than (\>) 50 Kg
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Metformin in Absence and Presence of VX-993
timeFrame: From Day 1 up to Day 14
measure: Area Under the Concentration Versus Time Curve for the Last Measurable Concentration (AUClast) of Metformin in Absence and Presence of VX-993
timeFrame: From Day 1 up to Day 14
measure: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of Metformin in Absence and Presence of VX-993
timeFrame: From Day 1 up to Day 14
Secondary outcomes:
measure: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to Day 29
measure: Renal Clearance (CLr) of Metformin in the Presence and Absence of VX-993
timeFrame: From Day 1 up to Day 14
measure: Metformin Fraction Excreted Unchanged (fe) in Urine in the Presence and Absence of VX-993
timeFrame: From Day 1 up to Day 14
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: ICON Salt Lake City
state: Utah
Study officials:
References:
Clinical trial NCT04642495: Objective Visual Acuity Measurement Using Suppression of the Optokinetic Nystagmus (OKN).
Official title: Clinical Application of Objective Visual Acuity Measurement Using Suppression Method to Inhibit Optokinetic Nystagmus (OKN).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 246
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers aged 4 and above

Brief summary: Suppression of the optokinetic nystagmus when a target is perceived can be applied to assess visual acuity objectively. Our aim is to establish prediction intervals for this optokinetic nystagmus suppression test (Speedwheel Test, SW) so that SW acuity may be used to estimate Snellen acuity (FrACT- C and -E) in the clinic in adults and children unable to cooperate in other acuity testing.

Detailed description: In this prospective single center study subjects aged at least 4 years underwent testing of visual acuity with SW, Landolt-C and Tumbling-E symbols (Freiburg acuity test: FrACT-C, FrACT-E). Prediction intervals are to be established for SW compared to FrACT-C or -E and for FrACT- E compared to FrACT-C.

Eligibility criteria: Inclusion Criteria:

* able and willing to perform the test

Exclusion Criteria:

* under 4 years of age
* unable or unwilling

Primary outcomes:
measure: Prediction intervals of Snellen acuity for the SW
timeFrame: 12 months
Secondary outcomes:
measure: Prediction intervals of Snellen acuity for Landolt C compared to E symbols
timeFrame: 12 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Basel, University Eye Hospital Basel
Study officials:
affiliation: University Basel, University Eye Hospital Basel
name: Anja M Palmowski-Wolfe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schwob N, Palmowski-Wolfe A. Objective measurement of visual acuity by optokinetic nystagmus suppression in children and adult patients. J AAPOS. 2019 Oct;23(5):272.e1-272.e6. doi: 10.1016/j.jaapos.2019.05.016. Epub 2019 Sep 14.
citation: Schwob N, Palmowski-Wolfe A. Establishing an Objective Measurement of Visual Acuity with a Computerised Optokinetic Nystagmus Suppression Test. Klin Monbl Augenheilkd. 2020 Apr;237(4):502-505. doi: 10.1055/a-1119-6123. Epub 2020 Apr 24.
citation: Luethy ML, Schotzau A, Palmowski-Wolfe A. Establishing Prediction Intervals for the SpeedWheel Acuity Test in Adults and Children. Klin Monbl Augenheilkd. 2021 Apr;238(4):488-492. doi: 10.1055/a-1403-2218. Epub 2021 Apr 14.
Clinical trial NCT06862895: Effect of Chest Physiotherapy on Clinical Outcome of Infants With Bronchiolitis
Official title: Effect of Chest Physiotherapy Educational Program on Mother's Knowledge, Practice and Clinical Outcomes of Infants With Bronchiolitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchiolitis
Infant, Newborn, Diseases
Chest Physiotherapy
Educational Program
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of clinical trial study is to evaluate effect of chest physiotherapy educational on mother's knowledge, practice and clinical outcomes of infants aged less than 12 months diagnosed with bronchiolitis by physician

The main questions aims to answer:

* Does chest physiotherapy improve clinical outcomes of infants with bronchiolitis?
* Does educational program improve mothers knowledge and practice regarding chest physiotherapy?

Researcher compare two groups one receive routine hospital care (control group) other receive chest physiotherapy applied by mothers in addition to routine hospital care and will be followed up for 3 days


Eligibility criteria: Inclusion Criteria:

* 1. Mothers of infants diagnosed with bronchiolitis. 2. Presence of crackle on auscultation.

Exclusion Criteria:

1. Children with contraindication of chest physiotherapy (ex. Fracture, recent surgery)
2. Children who intubated and admitted to Intensive Care Unit (ICU).

Primary outcomes:
measure: change in Clinical Outcomes of Infants with Bronchiolitis
timeFrame: baseline
measure: change in physiological outcomes of Infants with Bronchiolitis
timeFrame: baseline
Secondary outcomes:
measure: Improvement in Knowledge of Mother's
timeFrame: After 3 days
measure: Improvement in practices of Mother's
timeFrame: After 3 days
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical University
state: Kurdistan
Study officials:
References:
Clinical trial NCT05077995: Validity and Reliability of the Polar M200 Activity Monitor
Official title: Validity and Reliability of the Polar M200 Activity Monitor to Measure Sedentary and Active Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Persons
Fitness Trackers
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study will be to investigate the validity of a consumer available activity tracker (Polar M200) in free-living conditions to measure sedentary time.

Detailed description: The aim of the present study is to evaluate the validity from a commercially available wearable Polar device. Consumer-based activity trackers are generally cheaper, designed for long-term wear and are less intrusive. Potentially, consumer-based activity trackers can be used for research purposes, but high-quality validation studies are needed. The aims of this study will be to assess validity of sedentary outcome measures of a Polar device during free-living conditions in comparison with the ActivPAL3TM activity monitor (AP; PAL Technologies Ltd, Glasgow, UK), which is considered the gold standard to measure sedentary time in free-living conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* /

Primary outcomes:
measure: Sedentary time
timeFrame: 7 days
Secondary outcomes:
measure: Steps
timeFrame: 7 days
measure: Sleeping time
timeFrame: 7 days
measure: Standing time
timeFrame: 7 days
measure: Walking time
timeFrame: 7 days
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Bert Op 't Eijnde, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00563095: A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer
Official title: A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: Schering-Plough
First posted: 2007-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary: To compare the efficacy of TACE and TAIE.

Secondary: To compare the side effects of TACE and TAIE.

The outcome measurements include survival benefit and tumour regression induced by the two therapies.


Eligibility criteria: Inclusion Criteria:

* Confirmed hepatocellular carcinoma not suitable for surgery

Exclusion Criteria:

* Portal vein thrombosis
* Severe arteriovenous shunt
* Bilirubin level \> 50 umol/mL
* Prothrombin time \> 5 seconds

Primary outcomes:
measure: regression of tumour size
timeFrame: assessment every 6 months
Secondary outcomes:
measure: side effects
timeFrame: every treatment given every 8 - 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital/ The University of Hong Kong
name: Man Fung Yuen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02466295: The Comparison of the Effect of Pressure-controlled Ventilation and Volume-controlled Ventilation on the Gastric Insufflations in I-gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate whether the pressure controlled ventilation can reduce gastric insufflation compared to the volume controlled ventilation in patients who were mechanically ventilated with the i-gel.


Eligibility criteria: Inclusion Criteria:

* adult patients aged over 20 yrs who are scheduled for surgery under general anesthesia

Exclusion Criteria:

* upper gastrointestinal surgery,
* surgery of long duration more than 4 hours,
* anticipated difficult intubation,
* body mass index more than 35 kg/m2,
* pregnancy

Primary outcomes:
measure: gastric antral area
timeFrame: Within 5 minutes after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03144895: Arterial Catheterization by Ultrasound
Official title: Arterial Catheterization by Ultrasound: Impact on Success Rates and Complications in Patients Hospitalized in Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasound Therapy; Complications
Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended

Detailed description: Monitoring of invasive blood pressure and / or cardiac output of resuscitation patients is required and recommended. The installation of an arterial catheter in intensive care is very frequent and subject to many complications. These complications are now well recognized in the literature, they are mainly vascular, infectious and thrombotic. They are directly influenced by the number of attempts to puncture and the time taken to perform the gesture. Many measures are taken to reduce the impact such as the choice of the site of installation, the strict aseptic techniques during the installation and the type of catheter used. However, despite these measures, it appears that the incidence of these complications remains high. Compared to anatomical marking, only the technique of laying the ultrasound-guided catheter has shown its effectiveness in reducing these complications. The management in intensive care of increasingly complicated, severe, elderly patients with significant comorbidities increases from year to year. To the knowledge of the investigator, there is no study on the impact of ultrasound arterial catheterization in patients in resuscitation.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years;
* Hospitalization in resuscitation;
* Necessity of installation of an arterial catheter
* Signed informed consent.
* Affiliation to a social security scheme

Exclusion Criteria:

* Patient under tutorship or curatorship
* Minor Patient

Primary outcomes:
measure: Success rate of arterial or femoral catheter placement
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
affiliation: CHU AMIENS-PICARDIE
name: Elie ZOGHEIB, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002/14651858.CD013585.pub2.