louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00712595: Mifepristone for Treatment of Uterine Fibroids
Official title: Mifepristone 5 mg Versus 10 mg for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine fibroids
mifepristone
antiprogestins
Lead sponsor: Mediterranea Medica S. L.
Sponsor class: OTHER
First posted: 2008-07-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this study are to estimate the efficacy and safety of the daily administration of mifepristone 5 mg versus 10 mg for three months for the treatment of uterine fibroids.

The hypothesis of the study is that both mifepristone doses reduce the volume of the myoma in about 40% after 3 months of treatment.

Detailed description: Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone.

The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.

Eligibility criteria: Inclusion Criteria:

* Symptomatic uterine leiomyomata
* Reproductive age or premenopausal
* Accepting the use of non hormonal contraception
* Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
* Agreeing to have ultrasound examinations in every follow-up or evaluation visit
* Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination.

Exclusion Criteria:

* Pregnancy or desire to become pregnant
* Breastfeeding
* Hormonal contraception or any hormonal therapy received in the last three months
* Signs or symptoms of pelvic inflammatory disease
* Adnexal masses
* Abnormal or unexplained vaginal bleeding
* Suspected or diagnosed malignant neoplastic disease
* Signs or symptoms of mental illness
* Adrenal disease
* Sickle cell anemia
* Hepatic disease
* Renal disease
* Coagulopathy
* Any other severe or important disease
* Any contraindication to receiving antiprogestins

Primary outcomes:
measure: Volume of the uterine leiomyomata with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
timeFrame: 3 months
Secondary outcomes:
measure: Volume of the uterus with 5 mg versus 10 mg daily of mifepristone after 3 months of treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Havana
country: Cuba
facility: Hospital Eusebio Hernández
state: Ciudad Habana
Study officials:
affiliation: Mediterranea Medica
name: Josep LL. Carbonell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382495: The Impact of COVID-19 Pandemic on Cancer Care
Official title: Impact of COVID-19 Pandemic on Cancer Care Provision: a Cross-sectional Study of Egyptian Patients' Perspectives and Concerns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Cancer Care
COVID-19
Lead sponsor: El Zaitoun Specialized Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Ain Shams University
First posted: 2020-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study survey will be distributed through social media to cancer patients and survivors in Egypt. We plan to enroll as many participants as possible without limitation of the number although we hope to achieve at least 400 participants.

Brief summary: The situation of COVID-19 pandemic creates many challenges for cancer patients and caregivers. Some modifications in cancer management have been evolved from cancer societies and organizations to support oncology professionals as much as possible to deliver optimal care to their cancer patients in such exceptional circumstances, and to protect patients from infection with COVID-19 as much as possible.

Detailed description: In oncology practice during this pandemic, many cancer patients still feeling uncertainty about their cancer management and treatment outcome . The study is aiming to better understand the impact of the COVID-19 pandemic on cancer care from patients' and survivors' perspective.

Eligibility criteria: Inclusion Criteria:

* cancer patients or survivors in Egypt.

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: patients' and survivors' perspective of their cancer care during COVID-19 pandemic
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: EgyBrit Medical Centre
Study officials:
affiliation: Ain Shams University
name: Ahmed Abdelaziz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04253795: Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery
Official title: Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Intubation
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).

Detailed description: Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective minor VATS procedures will be enrolled the study

Exclusion Criteria:

* patients \<18 years old,
* body mass index (BMI)\>30 kg/m2,
* American Society Association (ASA) Class\>3,
* heart failure (New York Heart Association class \> II),
* a history of arrhythmia or treatment with antiarrhythmic drugs,
* bradycardia (heart rate (HR) \<45 beats min1)
* atrioventricular block,
* hepatic or renal dysfunction,
* coagulopathy,
* asthma
* sleep apnea syndrome

Primary outcomes:
measure: difference in PaO2/FiO2 ratio at the end of the surgery
timeFrame: 1 hour
Secondary outcomes:
measure: Anesthesia time
timeFrame: 20 minutes
measure: Operating room time
timeFrame: 1 hour
measure: Post anesthetic care unit (PACU) time
timeFrame: 30 minutes
measure: Surgeon satisfaction
timeFrame: 10 minutes
measure: Patient satisfaction
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Training and Reseach Hospital Department of Anesthesiology and Reanimation
Study officials:
affiliation: Antalya Training and Research Hospital
name: Ali Sait Kavakli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya Training and Research Hospital
name: Tayfun Sugur, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01001195: Safety and Efficacy of Three Formulations of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-10-26
Enrollment: 165
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: This study will evaluate the safety, efficacy and dose-response of AGN-210669. This study will also compare AGN-210669 with bimatoprost ophthalmic solution (LUMIGAN®).


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Patient requires IOP lowering medication in each eye

Exclusion Criteria:

* Ocular hyperemia or other ocular surface findings in either eye
* Active ocular disease
* Current or anticipated use of any topical ocular medication (including artificial tears) during the study
* Intraocular surgery within past six months or unilateral cataract surgery.
* Functionally significant visual field loss
* Anticipated wearing of contact lenses during study
* Use of other medications that affect IOP such as glaucoma treating medications, within 2 months of screening visit

Primary outcomes:
measure: Change From Baseline in Average Eye Intraocular Pressure (IOP)
timeFrame: Baseline, Day 29 Hour 0
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
state: New York
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00230295: Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
Official title: Indirect Magnetic Resonance Lymphangiography of the Head and Neck Region Using Conventional Gadolinium-based Contrast
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2005-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H\&N cancers


Eligibility criteria: Inclusion Criteria:Patients with newly diagnosed squamous cell carcinomas of the H\&N with primary tumor sites that are accessible to direct contrast injections

Primary outcomes:
measure: To determined the ability of magnetic resonance lymphangiography using conventional gadolinium injected directly into the tumor site and PET scan in detecting microscopic nodal metastasis in patients with newly diagnosed H&N cancers
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Quynh-Thu Le
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099795: Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
Official title: Evaluation of Concordance Between an Innovative Test on Exhaled Air (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 in Symptomatic Patients or Closed Contacts
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SARS-CoV-2 Infection
COVID-19
Coronavirus
Keywords: Diagnostic Test Kits
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University of Nimes
name: brains' laboratory sas, FRANCE
First posted: 2023-10-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: During the COVID-19 pandemic, testing primarily relied on the use of nasopharyngeal swabs to detect the SARS-CoV-2 virus, responsible for the disease. However, this technique has several limitations, including the variable quality of swabs, its invasive nature, and arbitrariness in the choice of the number of cycles. Furthermore, it does not allow for the detection of viral proteins.

To overcome these limitations, researchers developed the eBAM-CoV test, patented for the detection of viral proteins in the exhaled air of COVID-19 patients. This portable device provides an immediate assessment of the "viral load" with both quantitative and qualitative results, showing promise for early virus detection.

The researchers hypothesize that the eBAM-CoV test is likely to exhibit a satisfactory concordance with the reference RT-PCR test in the detection of COVID-19, especially among symptomatic patients or closed contacts.


Eligibility criteria: Inclusion Criteria:

* Adult male or female patients over 18 years of age (≥)
* Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening.

Exclusion Criteria:

* Inability to understand the procedures to use the device
* Patient participating in an another interventional study
* Patient in exclusion period determined by another study
* Patient under court protection or guardianship
* Patient/trusted person/legal representative/family member for whom it is impossible to give informed information.
* Pregnant, parturient or breast-feeding patient

Primary outcomes:
measure: Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection
timeFrame: Day 0
Secondary outcomes:
measure: diagnostic performance of the eBAM-CoV test
timeFrame: Day 0
measure: concentration of SARS-CoV-2 viral proteins
timeFrame: Day 0
measure: Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR
timeFrame: Day 4
measure: Concordance between eBAM-CoV test and antigenic test
timeFrame: Day 0
Other outcomes:
Locations:
city: Marseille
country: France
facility: Laboratoire Alphabio, Hôpital Européen Marseille
city: Nîmes
country: France
facility: CHU de NIMES
Study officials:
References:
Clinical trial NCT04164095: A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus
Official title: A Multicenter Randomized Controlled Study of the Effect of Laparoscopic Preservation of the Pylorus and Vagus Nerve on the Postoperative Quality of Life in Patients With Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Quality of Life
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Dalian Medical University
name: Affiliated Hospital of Qinghai University
name: Zhejiang Cancer Hospital
name: Second Affiliated Hospital of Suzhou University
First posted: 2019-11-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For the patients with early gastric cancer (T1), preoperative evaluation (gastroscope, ultrasound gastroscope and abdominal enhanced CT) showed that the tumor was located in the body of the stomach, and the margin was enough to retain the pylorus and non lymph node metastasis (N0). Lappg (D1 + lymph node dissection) and traditional laparoscopic distal gastrectomy (BII type anastomosis, D1 + lymph node dissection) were included A control study was conducted to evaluate the influence of two surgical methods on the long-term quality of life of patients after operation


Eligibility criteria: Inclusion Criteria:

1. 18 years old \< age \< 75 years old;
2. primary gastric lesions were diagnosed as gastric adenocarcinoma by biopsy;
3. the preoperative clinical stage was T1N0M0 according to ajcc-7thtnm;
4. it is predicted that R0 can be obtained by pylorogastric gastrectomy and D1 + lymph node dissection;
5. preoperative ECoG physical state score 0 / 1;
6. preoperative ASA score I-III;
7. informed consent of patients.

Exclusion Criteria:

1. pregnant or lactating women; suffering from serious mental illness;
2. the history of upper abdominal surgery (except laparoscopic cholecystectomy);
3. history of gastric surgery (including ESD / EMR for gastric cancer);
4. preoperative imaging examination showed regional enlarged lymph nodes;
5. having other malignant diseases within 5 years;
6. patients with gastric cancer who have received new adjuvant therapy or recommended new adjuvant therapy;
7. there was a history of unstable angina or myocardial infarction within 6 months;
8. have a history of cerebral infarction or cerebral hemorrhage within 6 months;
9. there was a history of continuous systemic corticosteroid therapy within 1 month;
10. simultaneous surgical treatment of other diseases is needed;
11. gastric cancer with complications (hemorrhage, perforation, obstruction) requires emergency surgery;
12. FEV1 of pulmonary function examination was less than 50% of the predicted value.

Primary outcomes:
measure: EORTC-QLQ-C30
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05244395: Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy
Official title: Development of a New Instrument to Evaluate Gait Characteristics of Individuals With Duchenne Muscular Dystrophy: Gait Assessment Scale for Duchenne Muscular Dystrophy, and Its Validity and Reliability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duchenne Muscular Dystrophy
Gait Disorders in Children
Gait Disorders, Neurologic
Keywords: Duchenne Muscular Dystrophy
gait pattern
scale development
reliability and validity
gait analysis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 56
Sex: MALE
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study was to develop a gait assessment instrument for Duchenne Muscular Dystrophy patients (DMD-GAS), and investigate its validity and reliability.The scale was developed considering the expert opinions which included 10 physiotherapists who had experience in the management of patients with DMD over the 2-round Delphi method, and the Content Validity Index (CVI) was calculated. The final version of the DMD-GAS that was agreed upon the experts consisted of 10 items, and each item scored between 0 and 2. The intra-rater reliability was established by the video analysis of children with a 1-month interval and inter-rater reliability was determined by the scores of 3 physiotherapists. The criterion validity was determined by investigating the relationship between the total score of the DMD-GAS and Motor Function Measure (MFM), 6 Minute Walk Test (6MWT), and the data obtained from GAITRite system.


Eligibility criteria: Inclusion Criteria:

1. Being diagnosed with DMD
2. Be between Levels I-V according to Brooke Lower Limb Extremity Functional Classification
3. Being between the ages of 5-18
4. Agreeing to participate in the research voluntarily

Exclusion Criteria:

1. Insufficient cooperation with the physiotherapist,
2. Have had any injury and/or surgery of the lower extremities in the last 6 months,
3. Having neurological problems in addition to DMD. -

Primary outcomes:
measure: Duchenne Muscular Dystrophy Gait Assessment Scale (DMD-GAS)
timeFrame: 15-20 minutes
measure: Motor Function Measure (MFM)
timeFrame: 20-30 minutes
Secondary outcomes:
measure: 6 meter walking test (6MWT)
timeFrame: 6 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Sıhhiye
Study officials:
affiliation: Hacettepe University
name: Güllü Aydın Yağcıoğlu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289795: Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
Official title: Endothelial Function and Progenitor Cells in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with first-ever ischemic stroke transferred to our stroke unit

Brief summary: The purpose of this study is to determine whether levels of circulating endothelial progenitor cells (cEPC) are increased in the acute phase of ischemic stroke.

Detailed description: Endothelial dysfunction is a key component of atherosclerosis which contributes to the development of cardio- and cerebrovascular diseases. However, endothelial dysfunction (ED) is not established as a risk factor for ischemic stroke.

As a novelty the proposed trial investigates the following variety of indirect markers of endothelial function in acute ischemic stroke:

circulating endothelial progenitor cells (EPC), endothelial microparticles (EMP), ENDOPAT (RH- PAT ratio) in two regards:

1. time after ischemic events (\< 48h, Days 4-5, day 7 or at discharge)
2. etiological stroke subtypes

It is not known whether these parameters are changed after acute cerebral ischemia and could possibly serve as specific target for treatment.

Eligibility criteria: Inclusion Criteria:

* Patients with first ever ischemic stroke
* TIA, or transient symptoms with infarction (TSI)
* Age \> or = 18 years old within 24 hours after onset
* Written informed consent to participate
* No evidence for dysphagia

Exclusion Criteria:

* Malignant hematopoietic disease (e.g. leukemia), severe systemic infections, severe immunological disease, renal or hepatic failure
* Pancreatitis, cholecystolithiasis, intestinal malabsorption
* Lactose intolerance
* Increased risk of aspiration
* Pregnancy
* Life expectancy less than 12 months
* Inability to give written informed consent
* Psychosis
* Alcohol dependency
* Abuse of illegal drugs

Primary outcomes:
measure: Levels of cEPC
timeFrame: <48h, day 4-5, discharge or day 7
Secondary outcomes:
measure: Levels of EMP
timeFrame: <48h, day 4-5, day 7 or discharge
measure: ENDOPAT
timeFrame: <48h, day 4-5,day 7
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Stroke Research Berlin
Study officials:
affiliation: Center for Stroke Research Berlin
name: Matthias Endres, MD
role: PRINCIPAL_INVESTIGATOR
References: