louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01979341: The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes
Official title: Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy
Ovarian Hyperstimulation Syndrome
Keywords: dual trigger
hCG
GnRH agonist
ICSI
pregnancy
OHSS
Lead sponsor: Antalya IVF
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.

In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.


Eligibility criteria: Inclusion Criteria:

* Age; \< 40 years
* Cycle number; cycles 1 or 2
* Antral follicle count; \>10 and \<25
* BMI; \>18 and \<30
* Normogonadotrophic cycle length; 24 to 25 days
* Male; ejaculated semen only

Exclusion Criteria:

* Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
* Previous major uterine surgery (that would affect endometrial receptivity)

Secondary exclusion criteria

* \<5 follicles at the time of trigger
* \<2 full formed blastocyst on day 5 of embryo culture

Primary outcomes:
measure: embryo implantation rate
timeFrame: 12 months
Secondary outcomes:
measure: oocyte maturation
timeFrame: 12 months
measure: Ovarian hyperstimulation syndrome
timeFrame: 12 months
Other outcomes:
measure: clinical pregnancy
timeFrame: 12 months
Locations:
city: Antalya
country: Turkey
facility: Antalya IVF
Study officials:
affiliation: Antalya IVF
name: Hasan Bulut, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya IVF
name: Kemal Ozgur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05334641: The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
Official title: The Effect of Music on Pain and Anxiety in Patients Receiving Chemotherapy During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapy
Keywords: Anxiety
COVID-19
Music
Pain
Patients receiving chemotherapy
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Introduction: This study has been conducted to determine the effect of music on pain and anxiety levels in patients receiving chemotherapy during COVID-19.

Methods: The research has been carried out in a real trial model with adult patients receiving chemotherapy. The sample of the study is consisted of 92 patients (45 in the experimental group and 47 for the control group). The data have been collected by the researcher with Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala) between March 2020 and July 2020, through the links sent to the phones of participants on the day they received chemotherapy.

Results: The mean scores obtained from the post-test STAI (53.11±4.77) and VAS (3.44±2.53) scales in the experimental group have been determined to statistically significantly decrease when compared to the pre-test measurement data (STAI:54.26±4.26; VAS:4.22±2.41) (p\<0.05). No statistically significant difference has been determined between pre-test and post-test mean scores of the patients in the control group.

Conclusion: It has been observed that music applications reduce the pain and anxiety levels of patients receiving chemotherapy during the COVID-19 process. It can be recommended to use music applications in the management of pain and anxiety symptoms.


Eligibility criteria: Inclusion Criteria:

* Over the age 18,
* Being able to communicate,
* Being literate,
* Having no diagnosis of psychiatric,
* Have the necessary technological equipment (phone, internet, etc.)

Exclusion Criteria:

* Existing infection
* Receiving palliative chemotherapy

Primary outcomes:
measure: Google Forms (using State and Transient Anxiety Inventory and Visual Analog Skala)
timeFrame: The posttest was administered 1 hour after the pretest.
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Vocational School of Health Services
Study officials:
affiliation: Inonu University
name: Rukuye AYLAZ
role: STUDY_DIRECTOR
References:
Clinical trial NCT03566719: Effect of an Exercise Program on Risk of Fall in a Community Dwelling Older Adults
Official title: Effectiveness of an Exercise Program for Prevention of Risk of Fall in a Community Dwelling Adults Over 55 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Fall Risk
Fall
Keywords: Prevention
Active Ageing
Fall
Fall Risk
Exercise Programs
Lead sponsor: Escola Superior de Tecnologia da Saúde de Coimbra
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 80
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Background: Falls are a problem among the elderly population, it is known that currently about 30% of people over 65 years falls every year. The European Union estimates a cost of € 281 per inhabitant per year and a cost of € 25 billion per year for health care1 which translates into a significant economic impact. The World Health Organization2 argues that it is possible to reduce these costs through prevention and health promotion strategies. For this, it is important to raise awareness, evaluate risk factors and identify and implement intervention programs. Objective: To test the effect of an exercise program on the prevention of risk of fall. Methods: This study, which lasted 4 months, was experimental, prospective. The experimental group (EG) performed an exercise program and the control group (CG) maintained their usual routine. For the measurement and evaluation of the variables under study, were used: sociodemographic data questionnaire, self-efficacy for exercise scale, Portuguese version of the falls efficacy scale (FES), 10m walking speed (WS), Timed Up \& Go test (TUG), step test and Hercules® Force Platform (static balance). A significance level of 5% (p ≤ 0.05) was considered for all comparisons.


Eligibility criteria: Inclusion Criteria:

* age equal or superior to 55
* community dwelling individuals

Exclusion Criteria:

* comprehension deficit
* significative heart disease
* restrictive breath disease

Primary outcomes:
measure: Change from baseline Force Platform at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline Timed Up&Go at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline Step test at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline 10-meters walking test at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline FES at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline Self efficacy for exercise at 4 months
timeFrame: 0 and 4 months
measure: Change from baseline Exercise program adherence at 4 months
timeFrame: 0 and 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IPC ESTeSC Coimbra Health School
name: Anabela C Martins, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04102319: Serum Hepcidin, Haemoglobin Level and Iron Status in Chronic Kidney Disease Patients (CKD) With Anaemia
Official title: Association Between Hepcidin, Haemoglobin Level and Iron Status in Stage 4 Chronic Kidney Disease Patients With Anaemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CKD Stage 4
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with chronic kidney disease stage 4 who have anemia with hemoglobin level below 11 gm/dl

Brief summary: The current study is planned to assess possible relationships of serum hepcidin levels with haemoglobin levels, inflammation and iron statuses in stage 4 CKD patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients (\>18 years) with anaemia who had CKD stage 4 with glomerular filtration rate (GFR) 15-29 ml/min/1.73 m2

Exclusion Criteria:

* Subjects with blood transfusion within the preceding 3 months. myocardial infarction (MI) history within the preceding 3 months, surgical history within the preceding 3 months, malignancy. Advanced liver cirrhosis. uncontrolled diabetes

Primary outcomes:
measure: relation between serum hepcidin level and ESR ckd stage 4
timeFrame: at study entry and then again after 3 months
measure: relation between serum hepcidin and serum ferritin levels
timeFrame: at study entry and then again after 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed Hamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03616119: Gastroesophageal Reflux Disease in Azerbaijan
Official title: The Prevalence of Gastroesophageal Reflux Disease in Azerbaijan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: gastoesophageal reflux disease
prevalence
Azerbaijan
Lead sponsor: Azerbaijan Gastroenterology and Hepatology Association
Sponsor class: OTHER
Collaborators: name: Azerbaijan Medical University
First posted: 2018-08-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Azerbaijan is divided by clusters with a definite numbers of individuals to take survey on reflux disease in the given age range and calculated by proportion of males and females.

Brief summary: To evaluate the prevalence of Gastroesophageal reflux disease in Azerbaijan. It is intended to evaluate the prevalence of the disease in the regions as well as the capital by cluster sampling ,ethitology and to compare the outcomes depending on the geographical location.

Detailed description: It is an observational, nationwide study. The GERD questionnaire (1994) requested from Mayo clinic, was received and validated. The questionnaire was translated by 3 individuals from english to azeri and back trasnlated by 3 native english speakers.

Power analysis was performed. The research was presented for the approval to Ethical Committee of Azerbaijan Medical University.

Prior to the actual study, a pilot study with smaller number of participants was performed and the results were evaluated.

Cluster sampling methodology was provided by the statistical department of Azerbaijan Medical University.

110 employees were hired for using a survey in different regions of Azerbaijan. Written consent was obtained from every person evaluated. Statistical ananlysis was performed.

Eligibility criteria: Inclusion Criteria:

* Age: 18-80
* Both genders
* Hearburn
* Belching
* Regurgitation

Exclusion Criteria:

* protom pomp inhibitor use
* antibiotic use in the last 4 weeks
* upper GI surgery

Primary outcomes:
measure: The prevalence of GERD in Azerbaijan
timeFrame: 1 year
measure: GERD questionnaire (GERD) of Mayo case 1998- 019
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: Azerbaijan Gastroenterology and hepatology Association
state: Nasimi
Study officials:
affiliation: Azerbaijan Gastroenterology and Hepatology Association
name: Sevda Aghayeva, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05737719: Utilization of Rehabilitation Prior to Surgery Among Patients With Anterior-cruciate Ligament Knee Injury
Official title: Utilization of Rehabilitation Prior to Surgery Among Patients With Anterior-cruciate Ligament Knee Injury: a Retrospective Review of the French National Health Database (Prehab-ACL)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior-cruciate Ligament Knee Injury
Keywords: Rehabilitation
Surgery
Health consumption
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 864000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preparing the patient for a surgical procedure had been well known in physiotherapy.

Presurgical exercise aiming to improve functional capacity before a surgical procedure leads to more rapid postoperative recovery compared with patients who remain physically inactive through the preoperative period

Brief summary: This research aims to assess physiotherapy utilization in the treatment of patients with an anterior-cruciate ligament knee injury, when delivered before their surgery (prehab), and its potential effects on absence from work, and patients global health consumptions (before and after the surgery).

Detailed description: Based on the codes generated from French National health database, patients with prehab (+post-surgery rehabilitation) will be compared to patients receiving only post-surgery rehabilitation

Eligibility criteria: Inclusion Criteria:

- First episod of ACL-surgery

Exclusion Criteria:

* No history or previous ACL-surgery
* No rehabilitation after surgery

Primary outcomes:
measure: Consumption of physiotherapy services
timeFrame: - 3 months up to surgery
measure: Consumption of physiotherapy services
timeFrame: from surgery up to 18 months later
measure: Absence from work
timeFrame: - 3 months up to surgery
measure: Absence from work
timeFrame: from surgery up to 18 months later
Secondary outcomes:
measure: Health consumption 1
timeFrame: - 3 months up to surgery
measure: Health consumption 1
timeFrame: from surgery up to 18 months later
measure: Health consumption 2
timeFrame: - 3 months up to surgery
measure: Health consumption 2
timeFrame: from surgery up to 18 months later
measure: Health consumption 3
timeFrame: from surgery up to 18 months later
measure: Health consumption 4
timeFrame: from surgery up to 18 months later
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03922919: Effect of Administration of 3rd Generation Cephalosporin on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (CEF-IMPACT)
Official title: Effect of Administration of 3rd Generation Cephalosporin (Ceftriaxone Versus Cefotaxime) on the Digestive Carrying of 3rd Generation Cephalosporin-resistant Enterobacteriaceae (EB C3G-R)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infectious Disease - Resistant Enterobacteriaceae (Diagnosis)
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: stepped-wedge design
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare the frequency of occurrence of digestive carrying of 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R), acquired during hospitalization in one of the participating departments, between patients treated with ceftriaxone and patients treated with cefotaxime


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Indication for antibiotic treatment with a 3rd generation injectable cephalosporin (cefotaxime or ceftriaxone)
* Signed Informed Consent

Exclusion Criteria:

* Hypersensitivity to ceftriaxone or cefotaxime, to another cephalosporin or to any of the excipients of the specialities concerned.
* History of severe hypersensitivity (e.g., anaphylactic reaction) to another class of antibacterial agent of the beta-lactam family (penicillins, monobactams and carbapenes)
* Subcutaneous administration of ceftriaxone
* Pregnant and breastfeeding woman
* Suspicion of Pseudomonas infection or documented Pseudomonas infection requiring ceftazidime treatment
* Suspicion of group III enterobacteriaceae infection or group III enterobacteriaceae infection requiring cefepime treatment

Primary outcomes:
measure: Frequency of occurrence of digestive carrying of EB C3G-R
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: incidence rate of EB C3G-R infections
timeFrame: 2 years
measure: number of patients with occurrence of positive rectal swab with 3rd generation cephalosporin-resistant enterobacteriaceae (EB C3G-R)
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
References:
Clinical trial NCT02034019: Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post Ocular Surgical Inflammation and Pain
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-13
Enrollment: 247
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: To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility criteria: Inclusion Criteria:

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination

Primary outcomes:
measure: Absence of Cells in Anterior Chamber of the Study Eye
timeFrame: Day 14
measure: Absence of Pain in Study Eye
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texan Eye / Keystone Research, Ltd.
state: Texas
Study officials:
affiliation: Ocular Therapeutix
name: Clinical Project Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT05850819: Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial
Official title: Effectiveness of Gelatamp in Wound Healing After Extraction of Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

Detailed description: In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.

In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

Eligibility criteria: Inclusion Criteria:

* Patients requiring extraction of mandibular teeth
* Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
* Patients not allergic to the drugs or anesthetics used in the study.

Exclusion Criteria:

* Patients taking medications that influences wound healing
* smokers
* Uncooperative patients
* Patients requiring extraction of grade II or III mobile teeth
* Patients requiring surgical extraction of teeth.

Primary outcomes:
measure: Postoperative wound healing
timeFrame: 7th postoperative day
measure: Postoperative pain
timeFrame: 1st postoperative day
measure: Postoperative pain
timeFrame: 2nd postoperative day
measure: postoperative pain
timeFrame: 3rd postoperative day
measure: postoperative pain
timeFrame: 4th postoperative day
measure: postoperative pain
timeFrame: 5th postoperative day
Secondary outcomes:
measure: Presence of dry socket
timeFrame: 3rd postoperative day
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka Manipal Medical College
Study officials:
affiliation: Melaka Manipal Medical College
name: Abdul K Azad
role: PRINCIPAL_INVESTIGATOR
References: