louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03484208: Evaluation of a Fracture Liaison Service in the Osteoporosis Care
Official title: Evaluation of a Fracture Liaison Service in the Osteoporosis Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteoporotic Fractures
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 346
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted in emergency yard for low energy fracture

Brief summary: The St JOSEPH'S HOSPITAL set up a fracture liaison service for osteopotic fracture. A specific nurse screens eligible patient admitted in emergency yard and call them to propose a bone densitometry and a medical coverage..

The aim of the study is to evaluate this new organisation


Eligibility criteria: Inclusion Criteria:

* Age between 45 and 95 years old.
* Admitted in emergency yard for law energy trauma

Exclusion Criteria:

* feet fracture
* fracture on prothesis
* patient transferred elsewhere
* homeless people
* patient with lot of comorbidities

Primary outcomes:
measure: valuable osteoporosis care
timeFrame: Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT04404608: Etiology of Lymphopenia in Covid19 Infection
Official title: Study of the Etiology of Lymphopenia in Covid19 Viral Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphopenia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 172
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted with the diagnosis off Covid19 viral infection of all ages and all ethnic backgrounds and agree about the study

Brief summary: Study of the cause of lymphopenia in Covid19 viral infection will be done in 3 cohorts. First cohort will be patients asymptomatic or with mild symptoms. Second cohort will be patients with severe illness and admitted to ICU. Third cohort will be patients critically ill and on artificial ventilation.

Detailed description: Each cohort will include 30 patients. Complete blood count in all patients will be done daily in all patients. Bone marrow aspiration cytology will be done in some selected patients especially those with lymphopenia less than 1000 per cubic mm.

Correlation of the degree of lymphopenia with the status of the patients will be done. Also correlation will be done about the relation of recovery of lymphopenia and status of the patients.

Eligibility criteria: Inclusion Criteria:

* Any patient admitted with the diagnosis of Covid19 viral infection

Exclusion Criteria:

* Any patient who died within one day of admission

Primary outcomes:
measure: Death or recovery
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute Cairo University
Study officials:
References:
Clinical trial NCT03125408: Clinical Performance Evaluation of DxN HCV Assay
Official title: Clinical Utility of the DxN HCV Assay as an Aid in the Management of HCV-Infected Individuals Undergoing Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects 18 years of age or older with chronic HCV who will undergo antiviral therapy to treat genotype 1,2 or 3 infections.

Brief summary: The DxN Hepatitis C Virus (HCV) Assay is an in vitro diagnostic assay intended as an aid in the management of of HCV-infected individuals undergoing antiviral therapy. The purpose of the study is to establish the clinical performance of the DxN HCV Assay for plasma samples in the intended use population.

Detailed description: Same as brief

Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older
* Subject has measurable HCV-RNA at baseline (prior to treatment start)
* Subject is genotype 2 or 3 and plans to undergo treatment with Peginterferon (PEG) plus Ribavirin (RBV) or Sofosbuvir (SOF) plus RIB
* Subject is genotype 1 and plans to undergo treatment with Telaprevir (TEL) or SOF plus PEG+RBV or, SOF plus Ledipasivr (LED)
* Subject is able to under information given, and willing and able to voluntarily give their consent to participate in study including signing consent form.

Exclusion Criteria:

* Co-infection with HIV or Hepatitis B (HBV)
* Prior participation in study
* Current participation in an investigation drug or device study

Primary outcomes:
measure: Sustained Virologic Response (SVR)
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duluth
country: United States
facility: SC Liver Research Consortium
state: Georgia
Study officials:
References:
Clinical trial NCT01674023: MicroRNA Expression Profile in Human Vitreous of Patients With Various Vitreoretinal Diseases Requiring Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MicroRNA Expression Profile in Human Vitreous of Various Vitreoretinal Diseases
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pateints undergoing vitrectomy for various vitreoretinal disesases

Brief summary: MicroRNAs are important regulators of many cellular functions but their expression profile in human vitreous is still unclear. Aim of this study is to investigate microRNA expression profile by PCR in human vitreous of patients with various vitreoretinal disorders and compare with that of patients with macular holes which are suggested to be similar to that of healthy subjects.


Eligibility criteria: Inclusion Criteria:

* any patients undergoing vitrectomy for various vitreoretinal diseases

Exclusion Criteria:

* previously vitrectomized eyes

Primary outcomes:
measure: MicroRNA expression profile in human vitreous investigated by PCR
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Mitakasi Sinkawa6-20-2
country: Japan
facility: Kyorin University School Of Medicine
state: Tokyo
Study officials:
References:
Clinical trial NCT05501223: Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic
Official title: Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy
Keywords: Polypharmacy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.

Detailed description: Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.

Eligibility criteria: Inclusion Criteria:

1. DM2
2. 12 medications in the central prescription list

Exclusion Criteria:

1. inability to give written consent (e.g., inability to understand the intervention or language barriers);
2. active cancer or palliative treatment;
3. admitted to the hospital.

Primary outcomes:
measure: Number of medications used at baseline compared to number of medications used at follow-up. Resulting in a rate of medications used at baseline compared to follow-up i.e. no. medication at follow-up/no. at baseline.
timeFrame: 6 months
Secondary outcomes:
measure: EQ5D index score. (a Euro Quality of Life 5-dimension 5-level (EQ-5D-5L) scale). The score is retrieved by using the validated EQ5D questionnaire which translates to a corresponding EQ5D index score using country specific value sets.
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT04452123: Endometrioma Treatment and Ovarian Function
Official title: Endometrioma Treatment and Ovarian Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrioma
Keywords: Endometrioma
AMH
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ovarian endometriosis (endometrioma) can be a cause of subfertility. According to European Society of Human Reproduction and Embryology (ESHRE) guidelines, surgery for endometrioma is recommended when an endometrioma is more than 3 cm in diameter because this management is associated with better spontaneous conception rates. Nevertheless, surgery can also be potentially associated with a risk of destruction of functional ovarian tissue and reduction in ovarian reserve.

Anti-müllerian hormone (AMH) is a member of the Transforming Growth Factor beta family and is expressed by the small (\<8 mm) pre-antral and early antral follicles. The AMH level reflects the size of the primordial follicle pool, and may be the best biochemical marker of ovarian function across an array of clinical situations Its level in serum is almost stable between 20 and 35 years of the woman´s life, unless using hormonal contraception and / or they suffer with Polycystic ovarian syndrome (PCOS). The level of AMH is also a useful indicator for the prediction chances of success of spontaneous or assisted conceptions. However, there paucity of data regarding changes in serum levels of AMH following surgery for endometrioma.

An alternative way for estimating ovarian reserve is quantifying ovarian mass with using standard 3D transvaginal ultrasound calculation (OVM) and assessment of antral follicular count.

The gold standard of endometrioma surgery is laparoscopic excision with suture or gentle coagulation of the rest of ovary or by the use of laparoscopic treatment with argon plasma energy.


Eligibility criteria: Inclusion Criteria:

* women with endometrioma 3cm and more in diameter

Exclusion Criteria:

* using hormonal contraception or other hormonal treatment last 6 months
* suffer with polycystic ovarian syndrome

Primary outcomes:
measure: AMH
timeFrame: 3 days,3-5 week postop., 3 months postop., 1 year (optional)
measure: Antral follicle count (AFC)
timeFrame: 3 months, 1 year
measure: Both ovarian volume
timeFrame: 3 months, 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: Departement of gynecology and obstetrics, University hospital in Pilsen
Study officials:
affiliation: Charles university in Pilsen
name: Jan Humplik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03830723: Personalized Insemination Treatment Study
Official title: Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Intrauterine Insemination
Reproduction
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2019-02-05
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open-label, prospective, dose-finding, single centre pilot study.
Primary purpose: TREATMENT

Brief summary: This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.

Detailed description: Study medication dosage for the first insemination cycle will be based on the woman's age as well as her Anti-Mullerian Hormone (AMH) levels.

Study medication dosage for the second and third insemination will depend on ovarian response (number of follicles) during previous insemination cycle and woman's age

Eligibility criteria: Inclusion Criteria:

* Women having consented to the study
* Women followed at fertility center
* First IUI cycle
* Women between the ages of 18 to 42 inclusively at time of consent form signature
* AMH \< 35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
* At least one permeable Fallopian tube confirmed by laparoscopy, hysterosalpingography (HSG), hysterosalpingosonography (HSSG) or one pregnancy in the last 3 years
* Insemination with either partner or donor sperm
* Male partner semen analysis considered adequate for IUI in accordance to the centre's standard practice
* Menstrual cycles from 26 to 39 days
* Presence of both ovaries

Exclusion Criteria:

* Unable to consent
* Body weight \>100 kg
* AMH ≥35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months
* Severe malformation (unicornuate or bicornuate uterus) or uterine anomaly including fibroids ≥ 5 cm
* Uncontrolled thyroid or adrenal dysfunction
* Pituitary tumour
* Persistent ovarian cysts or enlargement not due to PCOS (Polycystic ovary syndrome) \> 3 cm
* Anovulatory women
* Use of contraceptives in the last 3 months prior to start of stimulation
* Diagnosis of hydrosalpinx
* Malignancies
* Breast pathology incompatible with gonadotropin stimulation
* Hypersensitivity to follitropin delta or to any ingredient in the formulation
* Addition of other infertility medication that can influence follicle stimulation and maturation such as growth hormone (GH)

Primary outcomes:
measure: Ovarian response
timeFrame: 1 year
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001223: Diagnosis and Treatment of Patients With Cystic Fibrosis
Official title: Diagnosis and Treatment of Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Liver Disease or Abnormalities
Diabetes
Pancreatic Insufficiency (Exocrine and Endocrine)
Keywords: Cystic Fibrosis
Pancreatic Insufficiency
Bronchiectasis
Liver Disease
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 9999
Sex: ALL
Minimum age (years): 4
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primarily local population but also any adult patient/relative that moves into the area, either through CF Foundation or relocating for personal reasons.

Brief summary: This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Detailed description: This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Eligibility criteria: * INCLUSION CRITERIA
* Patients with known or suspected CF and family members of patients with CF.
* \>=4 years of age

EXCLUSION CRITERIA

-Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.

Primary outcomes:
measure: To develop a database and collection of samples obtained from patients with CF during their clinical care to allow for future research
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Milica S Chernick, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01037023: Regulatory Hycamtin(Oral) PMS
Official title: An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of HYCAMTIN Administered in Korean Patients According to the Prescribing Information
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer, Small Cell
Keywords: PMS (post-marketing surveillance)
Topotecan
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-12-21
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: Patients administrated Topotecan at the site

Brief summary: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information

Detailed description: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Topotecan administered in Korean patients according to the prescribing information

Topotecan will be administered as described the prescribing information or by physician's decision.

Eligibility criteria: All subjects must satisfy the following criteria.

* Subject who is under the indication to the prescribing information of oral Hycamtin.
* Subject who is treated with oral Hycamtin according to the judgement of her or his investigator.

All subjects must not satisfy the following criteria.

• Subject who is under the contraindication to the prescribing information of oral Hycamtin.

As considering the characteristic of observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe oral Hycamtin according to prescribing information which approved in Korea.

Primary outcomes:
measure: Occurrence of adverse events after Topotecan administration
timeFrame: 9 months
Secondary outcomes:
measure: Occurrence of unexpected adverse event or adverse drug reaction
timeFrame: 9 months
measure: Occurrence of serious adverse event or adverse drug reation
timeFrame: 9 months
Other outcomes:
Locations:
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04194723: Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
Official title: Phase II Clinical Study on the Safety and Efficacy of Antireflux Mucosectomy (ARMS) for Treatment of Gastroesophageal Reflux
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastro Esophageal Reflux
Keywords: Antireflux Mucosectomy
GERD
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II clinical study to investigate the safety and efficacy of endoscopic antireflux mucosectomy (ARMS) for treatment of GERD.

Detailed description: The objective of the study is to establish the clinical efficacy and safety of ARMS for treatment of GERD.

Eligibility criteria: Inclusion Criteria:

1. Patients with typical symptoms of GERD with symptomatic response to PPI therapy for ≥ 3 months
2. Hill's grade II and III of the gastroesophageal junction
3. One of the following abnormalities in the objective assessment 3.1. Excessive acid exposure at the distal esophagus evidenced by 24 hour pH tests using % total time pH \< 4 and / or DeMeester score 3.2. Endoscopic evidence of LA classes A,B,C or D esophagitis 3.3. Defective LES assessed by HRM with resting pressure of \< 6mmHg or total length of less than 4cm or abdominal length of less than 2cm

Exclusion Criteria:

1. Age \> 70 yrs of \< 18 yrs
2. Pregnancy
3. Any type of Hiatus hernia
4. Patients with underlying malignancy
5. ASA above grade III

Primary outcomes:
measure: Improvement in Gastro Esophageal Reflux symptoms
timeFrame: 3 months
Secondary outcomes:
measure: Technical Success
timeFrame: 1 day
measure: 24 hour pH study post ARMS
timeFrame: 3 and 12 months
measure: High resolution Manometry
timeFrame: 3 and 12 months
measure: Gastroesophageal junction classified by Hill's classification
timeFrame: 3 and 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Combined Endoscopy Center, Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT03770923: Effect of Some Drugs on Rheumatoid Arithritis Activity
Official title: Clinical Study Evaluating the Effect of Histamine 1 Receptor Antagonist and Leukotreine Receptor Antagonist on Patients With Rheumatoid Arithritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 75
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: Effect of Some Drugs on Rheumatoid Arithritis Activity.

Detailed description: The study aims at evaluating the effect of Some Drugs on Rheumatoid Arithritis Activity.

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis

Exclusion Criteria:

* liver or renal disease

Primary outcomes:
measure: se level of IL-17
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Head of Clinical Pharmacy Department
name: Sahar k Hegazy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical pharmacy Department- Tanta University
name: Tarek M Mostafa, Prof
role: STUDY_DIRECTOR
affiliation: Rheumatology Dept. - Tanta University
name: Salwa E Abd El-Ghany, Prof
role: STUDY_CHAIR
affiliation: Clinical pharmacy Department-Tanta University
name: Fedaa AK Kotkata, Msc
role: STUDY_CHAIR
References:
citation: Mostafa TM, Hegazy SK, El-Ghany SEA, Kotkata FAE. Comparative study evaluating antihistamine versus leukotriene receptor antagonist as adjuvant therapy for rheumatoid arthritis. Eur J Clin Pharmacol. 2021 Dec;77(12):1825-1834. doi: 10.1007/s00228-021-03181-2. Epub 2021 Jul 4.