louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04308343: The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Official title: The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ectopic Pregnancy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to :

1. Use of the aromatase inhibitor( letrozole) for the treatment of ectopic pregnancy compared to methotrexate.
2. Use of the Gnrh antagonist for the treatment of ectopic pregnancy compared to methotrexate.


Eligibility criteria: Inclusion Criteria:

* Patients who have undisturbed ectopic pregnancy .Who are:

  1. have no significant pain
  2. have an unruptured tubal ectopic pregnancy with an adnexal mass smaller than 35mm with no visible heartbeat
  3. have a serum human chorionic gonadotropins level less than 1,500 IU/litre
  4. do not have an intrauterine pregnancy (as confirmed on an ultrasound scan) .

Exclusion Criteria:

1. An undisturbed ectopic pregnancy and significant pain
2. An undisturbed ectopic pregnancy with an adnexal mass of 35 mm or larger
3. An undisturbed ectopic pregnancy with a fetal heartbeat visible on an ultrasound scan
4. An undisturbed ectopic pregnancy and a serum human chorionic gonadotropins level of 5,000 IU/litre or more
5. intrauterine pregnancy

Primary outcomes:
measure: determine efficacy of the aromatase inhibitor and Gnrh antagonist to achievement of resolution of ectopic pregnancy determined by serum hCG levels below laboratory immunoassay detection <15 IU/l.Results will be statistically analyzed,then evaluated .
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05152043: Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects
Official title: Effects of Romadan Fasting on Variability in Blood Pressure in Healthy and Hypertensive Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Ramadan fasting
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.

Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patient clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Brief summary: Included participants who have a stable HT who intend to practice RJ

Detailed description: Stable patients with or without diagnosed hypertension that intend to fast ramadan. Each participant is examined during three planned visits. The first takes place during the month preceding Ramadan. The second during the last week of Ramadan and the third thirty days after the end of Ramadan.

Participants that miss one appointement or more are exluded from the study. Patient recrutement is conducted in primary care centers of the state of Monastir, out-patients clinic (Cardiology, Endocrinology) at the emergency department of Fattouma Bourguiba university hospital after a clarified written consent.

Eligibility criteria: Inclusion Criteria:

* Adult patient with or without diagnosed hypertension intending to fast Ramadan.

Exclusion Criteria :

* Age \< 30 years old
* Adult patient with or without diagnosed hypertension not intending to fast Ramadan.

Primary outcomes:
measure: Blood Pressure Variability
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04768543: Stimulation Therapy for Apnea: Reporting Thoughts
Official title: Stimulation Therapy for Apnea: Reporting Thoughts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
upper airway stimulation therapy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Inspire Medical Systems, Inc.
First posted: 2021-02-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe OSA treated with UAS (Inspire Medical Systems, Maple Grove, Minnesota) who are part of the ADHERE registry.

Brief summary: Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* ADHERE registry patient
* Received UAS implant from June 2017 to present

Exclusion Criteria:

* Patients without up to date contact information

Primary outcomes:
measure: Experiences with UAS therapy
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Faith Luyster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luyster FS, Ni Q, Lee K, Harrison C, Ramprasad VH, Soose RJ, Strollo PJ. Factors affecting obstructive sleep apnea patients' use of upper airway stimulation treatment. J Clin Sleep Med. 2022 Sep 1;18(9):2207-2215. doi: 10.5664/jcsm.10086.
Clinical trial NCT05300243: The Predictive Role of HPV Integration in HSIL and Cervical Cancer
Official title: The Predictive Role of HPV Integration in HSIL and Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Integration
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It is expected to be included in 2000 female in this study.

Brief summary: The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.


Eligibility criteria: Inclusion Criteria:

* HPV-positive patients； Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy； Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors； Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.

Exclusion Criteria:

* Patients who are not suitable for the trial； Patients existing other subtype malignancy tumors are still in treatment.

Primary outcomes:
measure: Tissue pathological diagnosis
timeFrame: 1year since HPV integrated test
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
name: Shuang Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03142243: Morphological Asymmetry in Elite Female Tennis Players
Official title: Morphological Asymmetry in Elite Female Tennis Players Competing in an International Tournament in Belgium: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Development; Unilateral
Keywords: Tennis
Asymmetry
Morphological
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Professional, or elite, female tennis players

Brief summary: Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in morphological adaptations to the dominant side of the body. The corresponding morphological asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (elite) female players. Furthermore, existing studies only examine the degree of morphological asymmetry of the upper extremity. Therefore, the aim of this study is to explore the morphological differences between the dominant and the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in elite female tennis players.


Eligibility criteria: Inclusion Criteria:

* Participants will have to be professional, or elite, female tennis players.
* The players will have to participate in international tournaments in Belgium.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Demographics
timeFrame: 01/07/2017 - 31/12/2018
measure: Anthropometry
timeFrame: 01/07/2017 - 31/12/2018
measure: Body Composition
timeFrame: 01/07/2017 - 31/12/2018
measure: Morphological asymmetry
timeFrame: 01/07/2017 - 31/12/2018
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Eva D'Hondt, PhD
role: STUDY_DIRECTOR
affiliation: Vrije Universiteit Brussel
name: Peter Clarys, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04424043: Neo-TACE-HAIC for BCLC B Stage HCC
Official title: Neoadjuvant Transartery Chemoembolization Plus Artery Infusion Chemotherapy With Surgery Versus Surgery Alone for Hepatocellular Carcinoma Patients With Barcelona Clinic Liver Cancer (BCLC) B Stage: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 280
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: Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment.

Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC.

Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate.

Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.


Eligibility criteria: Inclusion Criteria:

* • Age 18-75 years;

  * BCLC B stage and tumor number \<=4;
  * Patients with resectable primary hepatocellular carcinoma;
  * Child-Pugh A or B (7 score) liver function;
  * The volume of residual liver more than 30%

Exclusion Criteria:

* • With unresectable HCC

  * Pregnant woman or sucking period;
  * With other malignant cancer;
  * Received anti-HCC therapy before this study

Primary outcomes:
measure: Progression-free survival, PFS
timeFrame: 36 months
Secondary outcomes:
measure: Overall survival, OS
timeFrame: 60 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan, MD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04741243: Effect of Extracorporeal Shock Therapy for Dysmenorrhea
Official title: Effect of Extracorporeal Shock Therapy for Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Shaimaa Mohamed Hamed
First posted: 2021-02-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was carried out upon forty women diagnosed as primary dysmenorrhea. They were selected from outpatient clinics of gynecology of Ain Shams University Hospital, Cairo University. Their age ranged from 25-35 years, BMI\<30kg/ m².

Detailed description: Patients with primary dysmenorrhea diagnosed by a physician, spondylolisthesis and chronic low back pain were excluded from the study. They were randomly assigned into two equal groups (A\& B). Group (A) consisted of twenty subjects, with an average age 29.2±1.9Yrs, and BMI 27.28±2.1kg/m2 who received Extracorporeal shock waves. Group (B) consisted of twenty patients, with an average age 28.58±2.2Yrs, and BMI 28.92±0.7kg/m2 who received sham technique. A hot pack was used for 15 minutes for both groups (A\&B) before the treatment.

Eligibility criteria: Criteria:

Inclusion Criteria:

* forty virgin females.
* their age ranged between 25 to 35 years old.
* Body mass index (BMI) \<30kg/ m².

Exclusion Criteria:

* females with pelvic pathology as endometriosis.
* females have irregular menstrual cycles.
* females have secondary dysmenorrhea.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: three months
Secondary outcomes:
measure: analysis of circulating β-endorphin
timeFrame: three months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ghada Elrefaye
state: Cairo
Study officials:
affiliation: Cairo University
name: ghada eb elrefaye, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01947543: Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study
Official title: Calmodulin Gene Mutations in Patients With Ventricular Arrhythmia of Unknown Origin - A Screening Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ventricular Tachycardia
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ventricular tachycardia of unknown origin and treated with an ICD

Brief summary: The aim of this study is to screen a well characterized patient population with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) for mutations in the calmodulin genes.

Detailed description: Patients with ventricular tachycardia of unknown origin and treated with an implantable cardioverter-defibrillator (ICD) will be asked to participate in the study. For patients with results showing mutations in the calmodulin genes, family members (parents, siblings and children) will also be asked to participate in the study. For under age patients and relatives who agree to participate, informed consent will also be taken from their custodian.

Eligibility criteria: Inclusion Criteria:

* Patients with ventricular tachycardia of unknown origin that have been treated with an ICD
* Signed and dated informed consent

Exclusion Criteria:

- Inability to provide informed consent

Primary outcomes:
measure: Mutations in the calmodulin genes
timeFrame: 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Cardiology, Örebro University Hospital
Study officials:
affiliation: Department of Cardiology, Örebro University Hospital, Örebro, Sweden
name: Ole Fröbert, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04375943: Clinical and Echocardiographic Management of Patients With Heart Failure and Diabetes: SCODIAC Follow up Study
Official title: Clinical and Echocardiographic Management of Patients With Chronic Heart Failure and Type 2 Diabetes Mellitus: the SCODIAC Follow up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Heart Failure
Keywords: diabetes
heart failure
ejection fraction
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 406
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 406 patient with HF and T2DM, referred to ARCA Cardiologists from 17 healthcare districts in Campania and to AMD Physicians from 8 Antidiabetic Centers and followed for at least one year between 2018 and 2019, were enrolled.

Brief summary: The study has been carried out to determine diagnostic and therapeutic pathways in a group of HF diabetic patients and to verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy.

Detailed description: 406 patients affected with heart failure and Type 2 Diabetes Mellitus, referred to Cardiologists and Diabetologists of pertaining healthcare districts in Campania, and followed for at least one year between 2018 and 2019, were enrolled in this retrospective study and divided in Group A, composed of 136 HF diabetic patients with preserved Ejection Fraction (HF-pEF) (\>45%) and Group B, formed of 270 HF diabetic patients with reduced EF (HF-rEF) (≤45%). All patients had performed periodic clinical evaluations and an echocardiographic exam every 12 months. Anthropometric parameters, HF etiology, co-morbidities, complications and ongoing therapies were collected.

Eligibility criteria: Inclusion Criteria:

* age at least 65 years
* presence of chronic HF, defined as a stable clinical syndrome with typical symptoms and signs and echocardiographic evidence of cardiac involvement
* New York Heart Association (NYHA) class II-III
* diagnosis of T2DM from at least 2 years

Exclusion Criteria:

* cardiac surgery performed during the last year
* age less than 65 years
* significant valvulopathies
* malignant neoplasms
* advanced chronic kidney disease

Primary outcomes:
measure: Total Cholesterol, LDL, HDL Triglycerides, Creatinine
timeFrame: 12 months
measure: B-type natriuretic peptide (BNP)
timeFrame: 12 months
measure: HbA1c
timeFrame: 12 months
measure: Ejection Fraction
timeFrame: 12 months
measure: Left Ventricular End-Diastolic Volume Index (LV-EDVi), Left Ventricular End-Systolic Volume Index (LV-ESVi), Left Atrial Volume Index (LAVi)
timeFrame: 12 months
measure: E velocity, A velocity,E' velocity
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University
Study officials:
affiliation: Federico II University
name: Ugo Oliviero
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02167243: A Reinforcement Approach to Improve Diabetes Management
Official title: A Reinforcement Approach to Improve Diabetes Management - Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-06-19
Enrollment: 62
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to evaluate the efficacy of a behavioral economic intervention to improve self monitoring of blood glucose (SMBG) in adolescents and young adults with T1D. The intervention will reinforce patients for conducting SMBG, with escalating reinforcers provided when patients achieved sustained periods of testing at least 4 times/day at appropriate intervals. A 6-month trial will be conducted in which 60 patients will be randomized to: (1) standard care or (2) standard care plus the reinforcement intervention.


Eligibility criteria: Inclusion Criteria:

1. age 12-21 years old;
2. diagnosis of type 1 diabetes (T1D) \>12 months via ADA guidelines
3. receiving diabetes treatment at Yale Pediatric Diabetes Clinic and not meeting clinical care guidelines
4. SMBG user with clinical recommendations to test \>4 times/day and using a device that allows for remote uploading (e.g., Aviva, Contour, Freestyle, Lifescan, etc.; equipment for uploading will be provided);
5. access to a computer with internet for uploading and sending SMBG data;
6. access to a cell phone with text messaging capabilities and willing to text after SMBG testing and receive messages about reinforcement;
7. English speaking, able to read at \>5th grade level, and pass an informed consent quiz; and adequate knowledge of insulin dosing and dietary recommendations for managing T1D.

Exclusion Criteria:

1. have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) that would inhibit participation;
2. have a major visual impairment;
3. have a significant other medical condition that impacts diabetes management (e.g., asthma, rheumatoid arthritis, or other condition that requires steroid treatment);
4. plan to switch insulin delivery mode (injection to pump or vice versa) in the next 12 months, or have recently switched;
5. are participating in another clinical trial.

Primary outcomes:
measure: To determine if the reinforcement intervention increases SMBG testing.
timeFrame: 6 Months
measure: To assess if the intervention reduces A1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: William Tamborlane, MD
role: PRINCIPAL_INVESTIGATOR
References: