louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02199067: Measurement of Exhaled Propofol
Official title: Measurement of Exhaled Propofol During a Total Intravenous Anesthesia With Propofol and Remifentanil
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anaesthesia With Propofol
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2014-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * patients undergoing elective surgery
* total intravenous anaesthesia

Brief summary: Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG \& Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).


Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anaesthesiologists) classification I \& II
* Body-Mass-Index \< 35
* elective surgery with the necessity of an arterial catheter

Exclusion Criteria:

* chronic obstructive lung disease
* bronchial asthma
* smokers with more than 5 packyears
* peripheral artery occlusive disease
* diabetes mellitus

Primary outcomes:
measure: exhaled propofol levels in breathing gas
timeFrame: continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
Secondary outcomes:
measure: propofol concentration in arterial blood serum
timeFrame: samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours
measure: Bispectral Index (BIS)
timeFrame: continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University Hospital
state: Bavaria
Study officials:
References:
Clinical trial NCT05971667: Effect of Tadalafil, Sildenafil and Pentoxyfylline on Frozen Embryo Transfer Outcomes
Official title: "Effect of Tadalafil, Sildenafil and Pentoxyfylline on Endometrial Thickness and Frozen Embryo Transfer Outcomes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: IVF
Keywords: Tadalafil
Sildenafil
pentoxyfylline
frozen embryo transfer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the Effect of different vasodilators as Tadalafil, Sildenafil and pentoxyfylline in In vitro Fertilization. In addition, the thickness of endometrium and pregnancies rates of these women will also be examined. All adverse effects of all drugs will be estimated

Detailed description: A prospective randomized clinical study will be conducted in the IVF clinic of the gynecology department of Beni Suef University Hospital, Beni-Suef, Egypt. The study will These patients will be randomized into four groups.

The participants will take drugs starting from the end of menstruation cycle till endometrium reach optimal and then will start progesterone 800 mg daily.

Eligibility criteria: Inclusion Criteria:

* women having thawed embryos

Exclusion Criteria:

* hypotension
* cardiovascular, hepatic, and renal diseases;
* uncontrolled diabetes mellitus;
* ovarian cysts;
* hyperprolactinemia;
* abnormal thyroid functions;
* uterine fibroids;
* patients taking nitrates;
* endometriosis and adenomyosis

Primary outcomes:
measure: endometrial thickness
timeFrame: within 16 day of menstruation
Secondary outcomes:
measure: pregnancy rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
References:
Clinical trial NCT02829567: Motivational Interviewing in Orthodontic Patients
Official title: Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 130
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.


Eligibility criteria: Inclusion Criteria:

* Orthodontic patients wearing fixed appliances, within the first six months of treatment
* Eruption completed (except for the third molars) or late mixed dentition.
* Caucasian

Exclusion Criteria:

* Pregnancy
* Periodontal disease
* Systemic illness
* Medical treatment

Primary outcomes:
measure: Assess change in oral hygiene using plaque index Löe & Silness
timeFrame: Baseline, 1 month and 6 months
Secondary outcomes:
measure: Assess change in oral hygiene using gingival index Löe & Silness
timeFrame: Baseline, 1 month and 6 months
Other outcomes:
Locations:
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Odontològic Universitat de Barcelona
state: Barcelona
Study officials:
affiliation: University of Barcelona
name: Maria Montserrat Rigau Gay, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin Psychol Rev. 2009 Jun;29(4):283-93. doi: 10.1016/j.cpr.2009.02.001. Epub 2009 Feb 23.
citation: Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.
Clinical trial NCT02052167: Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis
Official title: Human Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Juvenile Idiopathic Arthritis
Lead sponsor: medac GmbH
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2014-01-31
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).


Eligibility criteria: Main Inclusion Criteria:

* patient of either gender aged ≥2 to \<21 years of age
* is a suitable candidate for treatment with injectable methotrexate for JIA per the patient's primary rheumatologist, with the previous or current diagnosis of active polyarticular course JIA

Main Exclusion Criteria:

* Is a female patient who is pregnant, trying to become pregnant, or breastfeeding, or of childbearing potential, sexually active but not practicing a highly reliable method of birth control during the study and at least 6 months thereafter
* Has contraindications for methotrexate
* Has a history of or current inflammatory arthritis or rheumatic autoimmune disease other than JIA
* Is unable, or does not have a caregiver able to comprehend written labeling and training materials

Primary outcomes:
measure: Evaluation of test case scenarios with observation and performance measures
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital & Clinics
state: Missouri
Study officials:
References:
Clinical trial NCT04190667: Homologous Recombination Deficiency Status in Epithelial Ovarian Cancer
Official title: A Study on the Homologous Recombination Deficiency Status in Chinese Population With Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epithelial Ovarian Cancer
Chinese
Homologous Recombination Deficiency
BRCA1 Mutation
BRCA2 Mutation
Prognosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 1300
Sex: FEMALE
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: Chinese population with confirmed diagnosis of epithelial ovarian cancer

Brief summary: The homologous recombination deficiency (HRD) status in Chinese population with epithelial ovarian cancer (EOC) is little known. This study would recruit 1300 Chinese EOC patients. A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status. The HRD model is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST). The mutated genes, HRD score model and their relationship with the prognosis, would provide a full description of for the Chinese EOC patients.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Pathological confirmation of epithelial ovarian cancer
* With available tumor tissues
* Given consents to participate the study

Exclusion Criteria:

* Not meeting all of the inclusion criteria

Primary outcomes:
measure: Frequency of targeted genetic mutations
timeFrame: Two years
measure: Homologous recombination deficiency (HRD) score
timeFrame: Two years
Secondary outcomes:
measure: Progression-free survival
timeFrame: Two years
measure: Overall survival
timeFrame: Two years
measure: Rate of sensitivity to platinum-based chemotherapy
timeFrame: Two years
measure: Rate of sensitivity to poly-(ADP-ribose) polymerase inhibitors
timeFrame: Two years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956367: Efficacy of Fractional Carbon Dioxide Laser Combined With Platelet-rich Plasma
Official title: Efficacy of Ablative Fractional Carbon Dioxide Laser Combined With Autologous Platelet-rich Plasma Versus Ablative Fractional Carbon Dioxide Laser and Placebo in the Treatment of Striae Gravidarum: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Striae Gravidarum
Keywords: Striae Gravidarum
carbon dioxide laser
platelet-rich plasma
Lead sponsor: Jose R. Reyes Memorial Medical Center
Sponsor class: OTHER_GOV
First posted: 2021-07-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study determined the efficacy of ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma versus ablative fractional carbon dioxide laser with placebo in the treatment of striae gravidarum of postpartum Filipino women.


Eligibility criteria: Inclusion Criteria:

* Postpartum patients with ages 18 to 45 years
* Fitzpatrick skin type III-V
* having bilateral symmetrical SG of red, white or a combination of both types.

Exclusion Criteria:

* pregnancy
* breastfeeding
* heavy consumption of alcoholic beverages
* dermatological conditions such as psoriasis, systemic lupus erythematosus and atopic dermatitis
* uncontrolled hypertension, diabetes mellitus, heart disease, acute and chronic liver/kidney impairment/disease;
* elevated liver function tests (SGPT, SGOT), and serum creatinine;
* intake of any medications that may influence the outcome of the study;
* intake of any vitamins/minerals or any supplements in the past 6 months; and
* application of any topical agents (e.g., whitening, anti-aging) in the past 6 months

Primary outcomes:
measure: Clinical improvement
timeFrame: 16 weeks
Secondary outcomes:
measure: Patient satisfaction rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Jose R Reyes Memorial Medical Center
state: NCR
Study officials:
affiliation: Jose R. Reyes Memorial Medical Center
name: Ivan Arni C Preclaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Faghihi G, Keyvan S, Asilian A, Nouraei S, Behfar S, Nilforoushzadeh MA. Efficacy of autologous platelet-rich plasma combined with fractional ablative carbon dioxide resurfacing laser in treatment of facial atrophic acne scars: A split-face randomized clinical trial. Indian J Dermatol Venereol Leprol. 2016 Mar-Apr;82(2):162-8. doi: 10.4103/0378-6323.174378.
Clinical trial NCT01723267: Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
Official title: Automated 3D (SonoAVC) vs 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF
3D ultrasound
SonoAVC
patients in IVF treatment
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte maturation and subsequent egg collection is largely based on follicle size. An accurate assessment of follicle size and appropriate timing of HCG result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2D technology on the timing of oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.

Detailed description: Not desired

Eligibility criteria: Inclusion Criteria:

* Age:18-39, cycle number 1-4

Exclusion Criteria:

* PCOS
* Endometriosis
* Poor ovarian response
* TESA sperm

Primary outcomes:
measure: percentage of matured oocytes
timeFrame: one IVF cycle (within two weeks)
Secondary outcomes:
measure: Fertilization rate in ICSI
timeFrame: one IVF cycle/ patient (within two weeks)
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: IVF Unit, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Avi Ben-Haroush, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01658267: Compliance With Dietary Recommendations in Children at Risk for Undernutrition
Official title: Compliance With Dietary Recommendations in Meeting Nutritional Requirements in Children at Risk of Undernutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Children
Under-nutrition
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 36
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess compliance with dietary recommendations, in conjunction with a nutritional supplement to meet the nutritional requirements in children and the effects of the compliance on promoting growth in children who are at risk of under-nutrition.

Detailed description: This study will assess compliance with dietary recommendations, in conjunction with an oral nutritional supplement to meet the nutritional requirements in children older than 36 (\>36) to less than or equal 48 (≤48) months of age, and the effects of the compliance on promoting catch-up growth and normal healthy growth in children who are at risk of under-nutrition.

Eligibility criteria: Inclusion Criteria:

* Child is between 36 and 48 months of age.
* Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile.
* Child is capable of oral feeding.
* Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period.

Exclusion Criteria:

* Child whose either parent has BMI greater than or equal to 27.5 kg/m2.
* Child allergic or intolerant to any ingredient found in the study product.
* Child who was delivered pre-term.
* Child was born small for gestational
* Child had birth weight \< 2500 g or \> 4000 g.
* Child has current acute or chronic infections.
* Child demonstrates presence of severe gastrointestinal disorders.
* Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases.
* Child has a diagnosis of hormonal or metabolic disorders.
* Child has a congenital disease or genetic disorder.
* Child is diagnosed with infantile anorexia nervosa.
* Child has a developmental disability or physical disorder.
* Child has disorders of hemoglobin structure, function or synthesis.
* Child is participating in another study that has not been approved as a concomitant study.

Primary outcomes:
measure: Compliance with recommendation of a nutritional supplement consumption
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manilla
country: Philippines
facility: Asian Hospital and Medical Center
city: Manilla
country: Philippines
facility: The Medical City
Study officials:
affiliation: Abbott Nutrition, Singapore
name: Dieu Huynh, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00480467: Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 in Healthy Japanese Males
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-315 Administered Orally to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-31
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of ascending single oral doses of SAM-315, an investigational drug, in healthy Japanese male subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-315 in healthy Japanese male subjects.


Eligibility criteria: Inclusion criteria:

* Men aged 20 to 45 years (inclusive) at the time of getting informed consent.
* Body mass index (BMI) in the range of 18.5 to 25.0 kg/m2 and body weight≥50 kg (BMI = \[weight (kg)\]/\[height (m)\]2).
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ECG). Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and creatinine levels must be within the upper limit of normal for eligibility.

Exclusion criteria

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
* Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or cola) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing products is prohibited from 72 hours before study day 1.

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Pharmacokinetics and pharmacodynamics
Other outcomes:
Locations:
city: Ibaraki Pref
country: Japan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References: