louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04539925: Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas
Official title: Impact of Short-term Air Pollution Exposure on Acute Coronary Syndrome in Two Cohorts of Industrial and Non-industrial Areas: A Time Series Regression With 6,000,000 Person-years of Follow-up (ACS - Air Pollution Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Air Pollution
Keywords: Acute Coronary Syndrome
Air pollution
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
Collaborators: name: Medical University of Bialystok
First posted: 2020-09-07
Enrollment: 9046
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study is performed in two big provincial cities in Poland, Europe, namely Bialystok and Katowice. In the last year of the analysis, the areas were inhabited by 294,925 and 296,262 residents, respectively.

Brief summary: Background: There is a lack of data on the effect of air pollution on acute coronary syndrome (ACS) in industrial and non-industrial areas.

Objectives: A comparison of association of air pollution exposure with ACS in two cohorts of industrially different areas.

Materials and methods: The study covered 6,000,000 person-years of follow-up and five types of air pollution between 2008 and 2017. A time series regression analysis with 7-lag was used to assess the effects air pollution on ACS.


Eligibility criteria: The study covered all residents from industrial (Katowice) and non-industrial (Białystok) areas.

Primary outcomes:
measure: Non-ST segment elevation myocardial infarction
timeFrame: 7 days
measure: ST-segment elevation myocardial infarction
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital
city: Katowice
country: Poland
facility: Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Study officials:
References:
Clinical trial NCT00411125: Pharmacokinetics and Pharmacodynamics Study of Oral Salmon Calcitonin in Healthy Postmenopausal Women
Official title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled Crossover Phase I Study Assessing Pharmacokinetics and Pharmacodynamics of Two Different SMC021 0.8 mg Variants and the Effect of Timing of Drug Intake in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis
Keywords: Postmenopausal
osteoporosis
Pharmacokinetics/dynamics
Calcitonin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-13
Enrollment: 86
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase I study to analyze bioavailability and pharmacodynamic of two different variants of oral salmon calcitonin (SMC021) in postmenopausal women


Eligibility criteria: Inclusion Criteria:

* Healthy postmenopausal women

Exclusion Criteria:

* Previous treatment with other osteoporosis medication

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pharmacokinetic profile of the new variant compared to the current variant on Day 1
measure: Effect on bone resorption biomarker on Day 1
Secondary outcomes:
measure: Effect on bone resorption biomarker 24 hours after the last dosing on Day 3
measure: Effect on bone resorption biomarker after drug intake at different timepoints
measure: Effect of dosing at different timepoints on the pharmacokinetic profile
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
Study officials:
affiliation: Novartis Basel +41 61 324 1111
name: Novartis Basel
role: STUDY_DIRECTOR
References:
citation: Karsdal MA, Byrjalsen I, Riis BJ, Christiansen C. Investigation of the diurnal variation in bone resorption for optimal drug delivery and efficacy in osteoporosis with oral calcitonin. BMC Clin Pharmacol. 2008 Dec 4;8:12. doi: 10.1186/1472-6904-8-12.
Clinical trial NCT00870025: Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients
Official title: hCG Priming Prior to COH in Poor Responder IVF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Response
Keywords: androgens
hCG
low response
IVF
Ovarian response in women with previous low response
Lead sponsor: IVI Madrid
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a decline in androgen concentration with ovarian aging. Also, ovarian response to COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian androgen concentration. A physiological way to induce androgen synthesis within the ovary is to stimulate theca cells androgen production by hCG stimulation. By doing this in the previous cycle we might expect a better response to COH.


Eligibility criteria: Inclusion Criteria:

* previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved

Exclusion Criteria:

* 42 years or older
* BMI \<18 or \>30

Primary outcomes:
measure: pregnancy rate
timeFrame: 2 weeks after intervention
Secondary outcomes:
measure: number of oocytes retrieved
timeFrame: 2 weeks after intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: IVI-Madrid
Study officials:
affiliation: IVI Madrid
name: Juan A Garcia-Velasco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
citation: Massin N, Cedrin-Durnerin I, Coussieu C, Galey-Fontaine J, Wolf JP, Hugues JN. Effects of transdermal testosterone application on the ovarian response to FSH in poor responders undergoing assisted reproduction technique--a prospective, randomized, double-blind study. Hum Reprod. 2006 May;21(5):1204-11. doi: 10.1093/humrep/dei481. Epub 2006 Feb 13.
Clinical trial NCT02043925: QT-prolongation in Psychiatric Hospitals
Official title: QT-prolongation in Psychiatric Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: QT-prolongation
Keywords: QT-prolongation
Torsade de Pointes
drug interactions
psychiatry
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
First posted: 2014-01-23
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug.

Brief summary: Observational study in 6 psychiatric hospitals in Flanders. Patients are included when a QT-prolonging drug is added to a medication profile that already contains a potential QT-prolonging drug. An ECG is taken before the administration of the new drug and a week after starting the new drug to investigate the change in duration of the QTc-interval. Risk factors for developing QT-prolongation and blood concentrations of potassium and creatinine are documented.


Eligibility criteria: Inclusion Criteria:

* inpatient in one of the 6 participating psychiatric hospitals
* QT-prolonging drug in the medication profile and the doctor prescribes another QT-prolonging drug

Exclusion Criteria:

* age \< 18 year

Primary outcomes:
measure: change in QTc-interval (corrected for heart rate)
timeFrame: before and one week after the start of a QT-prolonging drug
Secondary outcomes:
Other outcomes:
Locations:
city: Eeklo
country: Belgium
facility: Psychiatrisch Centrum Sint-Jan
Study officials:
affiliation: KU Leuven
name: Eline Vandael, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169325: Clinical, Neurophysiological and Radiological Evaluation of Patients With Basal Ganglia Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Ganglia Lesions
Keywords: basal ganglia
loss of psychic self-activation
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lesion of the basal ganglia structures

Brief summary: Basal ganglia are involved in the control of motor, cognitive and emotional behaviours. The aim of this study is to precisely evaluate patients with basal ganglia focal lesions both with or without loss of psychic-self activation.


Eligibility criteria: Inclusion Criteria:

* Basal ganglia lesions

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Dementia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'Investigation Clinique-Hôpital Pitié-Salpetriere
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Bruno Dubois, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581425: Intron-A/Aldara Combination Therapy for Basal Cell Carcinoma (BCC)
Official title: Intron-A/Aldara Combination Therapy for BCC Excluding the Face and Scalp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Basal Cell Carcinoma
Keywords: BCC
Basal Cell Carcinoma
Intron-A
Aldara
Basal Cell Carcinoma excluding scalp and face
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A trial to see if BCC excluding the scalp and face can be treated successfully with a combination therapy of Intron-A and Aldara.


Eligibility criteria: Inclusion Criteria:

* Nodular or superficial basal cell carcinoma on the skin excluding scalp or face

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: resolution of basal cell carcinoma
timeFrame: 2 years
Secondary outcomes:
measure: resolution of basal cell carcinoma at a lower cost and less inflammation.
timeFrame: 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center of Houston Dermatology Clinic
state: Texas
Study officials:
affiliation: University of Texas Health Science Center of Houston Dermatology Clinic
name: Stephen B Tucker, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01230125: Mapracorat Ophthalmic Suspension for the Treatment of Ocular Inflammation Following Cataract Surgery
Official title: Study to Assess the Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Keywords: Inflammation
Pain
Ocular surgery
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-28
Enrollment: 311
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 objective of this clinical study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Participants who are candidates for routine, uncomplicated cataract surgery
* Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
* Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.

Exclusion Criteria:

* Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
* Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
* Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
* Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
* Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Primary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
timeFrame: 8 days
measure: Percentage of Participants With Grade 0 Pain
timeFrame: 8 days
Secondary outcomes:
measure: Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.
timeFrame: 8 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rabia Ozden, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02313025: A Speech Sound and Phonemic Awareness Intervention in Flemish Early Childhood Education
Official title: Spreken Verfijnen in de Kleuterklas: De Ontwikkeling Van Een Spraakdidactiek Als Uitbreiding op de Gangbare Taaldidactiek in Het Kleuteronderwijs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Developmental Disorders of Speech and Language
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The language intervention 'Kaatje Klank' is designed for stimulating the speech production and speech perception skills of 4-year-olds in an early childhood educational setting, in order to stimulate early literacy skills. These skills are crucial skills for technical reading in later ages. Good reading skills are an important condition for academic success.

To measure the effect of the language intervention 'Kaatje Klank', the intervention will be applied in six Dutch preschool classes (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) during 12 weeks (daily). Teachers will be trained and observed using a coaching trajectory.To measure the effect on speech production and perception skills, a pre- and posttest and a comparison with a matched control group (n = 100 children, 50% native speakers of Dutch, 50% non-native speakers) will be used. The control group will receive a different language intervention which focuses on vocabulary development (World-project).


Eligibility criteria: Inclusion Criteria:

* In eary childhood education in Flanders (2de kleuterklas)

Exclusion Criteria:

* Language or speech disorder
* Less than 1 year acquiring Dutch

Primary outcomes:
measure: test battery: speech articulation test + phonemic awareness
timeFrame: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 16 minutes
Secondary outcomes:
measure: vocabulary test (Wereldwoorden project)
timeFrame: Participants will be tested after an intervention of 12 weeks. The expected average test duration is 4 minutes
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Odisee
state: Oost-Vlaanderen
Study officials:
affiliation: KU Leuven
name: Lieve Van Severen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06645925: Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible
Official title: Novel Soft Tissue Augmentation Technique Using Free Gingival Graft Simultaneous With Implant Placement in Posterior Mandible: A 1-year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Free Gingival Graft
Free Gingival Graft Volume Change
Keratinized Tissue
Keywords: FGG
Delayed implant placement
Keratinized mucosa
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Presence of keratinized tissue (KT) around dental implants, plays a crucial role in stability and health of peri-implant tissues. Several studies reported that, minimum of 2 mm keratinized tissue width is required to achieve long-term longevity. Insufficient keratinized mucosa leads to biofilm accumulation, soft tissue inflammation, eventually peri-implant mucositis and peri-implantitis. Hence, the aim of the present trial is to evaluate KTW gain, linear and volumetric changes in buccal soft tissue along with hard tissue alterations following implant restoration at sites treated either with delayed implant placement \&amp;amp; simultaneous FGG or the conventional FGG protocol prior to implant placement.


Eligibility criteria: Inclusion Criteria:

* Adults at or above the age of 18.
* Lower Posterior missing tooth/ teeth with minimal KT \&lt; 2mm
* Sufficient alveolar ridge length minimum 13-15 mm to IAN

  •. Sufficient alveolar ridge width minimum of 6 mm
* Patients able to tolerate surgical periodontal procedures.
* Patients who provided an informed consent and accepted the one-year follow-up period.

Exclusion Criteria

* Patients diagnosed with periodontal diseases (Caton et al., 2018).
* Current or previous smokers.
* Pregnant and lactating females.
* Patients with medical conditions that would compromise the surgical procedures; uncontrolled diabetes mellitus, taking intravenous Bisphosphonates for treatment of osteoporosis.
* Patients with active infection related to the site of implant.
* Patients with parafunctional habits.
* Patients with shallow vestibule

Primary outcomes:
measure: Keratinized tissue width
timeFrame: 0 - 3 - 6 - 12 months
Secondary outcomes:
measure: Linear changes in buccal soft tissue contour
timeFrame: 0-3, 0-6, 0-12 Months
measure: Interdental Papilla height changes
timeFrame: 12 months
measure: Midfacial margin changes
timeFrame: 12 Months
measure: Crestal bone level changes
timeFrame: 12 Months
measure: Bone labial to the implant
timeFrame: 12 Months
measure: Survival Rate
timeFrame: 12 Months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: IDCE
Study officials:
References:
Clinical trial NCT06172725: Improvements by a Protein-Rich Plant-Based Diet and Resistance Exercise Program for Active Ageing
Official title: Improvements by a Protein-Rich Plant-Based Diet and Resistance Exercise Program for Active Ageing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Protein Intake
Lead sponsor: Amsterdam University of Applied Sciences
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: High-protein intake and physical activity are important approaches to preserve muscle mass. Consuming high levels of high-quality proteins to preserve muscle mass is challenging with a plant-based diet. The healthy, older participants will follow a twelve-week high-protein vegetarian diet or high-protein omnivorous diet both in combination with a resistance training program. The change in protein intake and muscle mass will be assessed.


Eligibility criteria: Inclusion Criteria:

* Aged 55 years or older
* BMI 18.5-30 kg/m2
* Living independently
* Ability and willingness to comply with the protocol
* Written an informed consent
* Consent of the study physician

Exclusion Criteria:

* Alcohol abuse (more than 14 glasses per week (women) or more than 21 glasses per week (men)) or drug abuse in the opinion of the study physician (CBS et al., 2017)
* Inability to understand the Dutch language
* Cognitive impairment (MMSE more than 25)
* Diagnosed chronic disease that may interfere with protocol (e.g., cardiovascular, gastrointestinal, neurological, known renal diseases (eGFR more than 60 mL/min (Levey \&amp;amp; Coresh, 2012), and/or diabetes)
* Current enrolment in an exercise program or other intervention study
* Planned a holiday during the intervention period and is unable to attend training sessions for more than 1 week

Primary outcomes:
measure: Protein intake
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University of Applied Sciences
state: Noord-Holland
Study officials:
References:
Clinical trial NCT02709525: Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human
Official title: Use of Hyaluronic Acid as a Therapeutic Strategy for Bone Repair in Human: a Split-mouth Randomized Triple-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Alveolar Bone Loss
Keywords: hyaluronic acid
bone repair
dental socket
cone beam computed tomography
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 16
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of hyaluronic acid (HA) on bone healing in human dental sockets.


Eligibility criteria: Inclusion Criteria:

* Orthodontic need for bilateral extraction of lower first premolars

Exclusion Criteria:

* Alcoholism, smoking, drug use and abuse of drugs; Systemic diseases: uncontrolled diabetes, blood dyscrasias, kidney or heart failure and osteoporosis; clinical or radiographic signs of pathological processes in the bone;

Primary outcomes:
measure: Percentage of bone formation
timeFrame: 30 days after extraction and treatment application
measure: Fractal dimension
timeFrame: 30 days after extraction and treatment application
measure: Dimensional Alveolar changes
timeFrame: 30 to 90 days after extraction and treatment application
measure: Percentage of bone formation
timeFrame: 90 days after extraction and treatment application
measure: Fractal dimension
timeFrame: 90 days after extraction and treatment application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais
name: Anderson Ferreira, Professor
role: STUDY_DIRECTOR
References: