louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00387517: Safety/Efficacy of Combo Therapy With Aliskiren & Hydrochlorothiazide vs Therapy With Hydrochlorothiazide Alone in Patients With Hypertension
Official title: An Eight-week Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren / HCTZ (150/25 mg and 300/25 mg) in Comparison With HCTZ 25 mg in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Diastolic
systolic
hypertension
aliskiren
blood pressure
hydrochlorothiazide
HCTZ
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-10-13
Enrollment: 726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the safety and efficacy of combination therapy of aliskiren/hydrochlorothiazide (HCTZ) 150/25 mg and 300/25 mg compared with HCTZ 25 mg in patients with hypertension who do not show response to HCTZ 25 mg over a 4-week period.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18 years old or older.
* Patients with a diagnosis of hypertension defined as follows:

  * Newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= mmHg and \< 110 mmHg at Visit 1.
  * All patients who have been treated for hypertension within the 4 weeks prior to Visit 1 must have a msDBP \>= 85 mmHg and \< 110 mmHg at Visit 2.
  * All patients must have a msDBP \>= 90 mmHg and \< 110 mmHg at Visit 5.
* Patients who are eligible and consent to participate in the study

Exclusion Criteria:

* Severe hypertension (msDBP \>= 110 mmHg and/or MSSBP \>=180 mmHg).
* Previous or current diagnosis of heart failure.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack, myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention.
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Mean sitting diastolic blood pressure lowering effect at baseline, and week 8.
Secondary outcomes:
measure: Mean sitting systolic blood pressure (msDBP) lowering from baseline to week 8
measure: Safety and tolerability
measure: Proportion of patients achieving a blood pressure control target at week 8
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Blumenstein M, Romaszko J, Calderon A, Andersen K, Ibram G, Liu Z, Zhang J. Antihypertensive efficacy and tolerability of aliskiren/hydrochlorothiazide (HCT) single-pill combinations in patients who are non-responsive to HCT 25 mg alone. Curr Med Res Opin. 2009 Apr;25(4):903-10. doi: 10.1185/03007990902804158.
Clinical trial NCT00092417: Evaluation of the Safety and Tolerability of a Higher Potency Dose of an Investigational Vaccine Among Adults 50 Years of Age and Older (V211-009)
Official title: Evaluation of the Safety and Tolerability of a Higher Potency Dose of Varicella Zoster Virus Vaccine Live (Oka/Merck)Among Adults 50 Years of Age or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-09-27
Enrollment: 695
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster

Exclusion Criteria :

* Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response

Primary outcomes:
measure: Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
timeFrame: Day 1-42 post vaccination
measure: Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
timeFrame: Day 1-5 postvaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions
timeFrame: Day 1-42 postvaccination
measure: Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes
timeFrame: Day 1-42 postvaccination
measure: Number of Participants With Fevers ≥101.0°F [≥38.3°C]
timeFrame: Day 1-21 postvaccination
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, Bundick ND, Li J, Chan IS, Stek JE, Annunziato PW; Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine. 2007 Feb 26;25(10):1877-83. doi: 10.1016/j.vaccine.2006.10.027. Epub 2006 Oct 30.
Clinical trial NCT05924217: Gynecology Beyond Gender: Cervical Cancer Screening in Transgender Men in France
Official title: Gynecology Beyond Gender: Exploration and Identification of Potential Obstacles and Levers in France for Cervical Cancer Screening in Transgender Men, by Conducting an Opinion Survey in a Specific Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Transgender Persons
Health Services for Transgender Persons
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Transgender men, i.e. individuals assigned the female gender at birth but identifying with the male gender, who retained the cervix

Brief summary: In France, cervical cancer screening is the subject of a national screening programme organized for all asymptomatic individuals aged 25 to 65 years with a cervix. The latter contributes greatly to the prevention and early treatment of this disease, whose public health challenge is recognized worldwide.

One of the objectives of this programme is to reduce inequalities in access. Transgender men, i.e. individuals assigned to the female gender at birth but identifying with the male gender, are concerned by this screening as long as they still have a cervix, according to the same modalities as for cisgender women.

However, they are often excluded from health care, including organized screening programs. Gender change in civil status is one of the obstacles.

The provision of gynaecological care is sometimes inadequate. The lack of knowledge of health professionals and the problems of discrimination that transgender people may face reduce the chances of having equitable access.

This survey aims to explore the perception that transgender men have of cervical cancer screening and to identify the challenges they face, the obstacles and the levers to access this prevention program.


Eligibility criteria: Inclusion Criteria:

* transgender male (assigned female at birth but identifying as male)
* aged 25 to 65 years
* Having retained her cervix
* Having had sex before.

Exclusion Criteria:

* Under 25 and over 65
* Not having retained his cervix
* History of cancerous lesion of the cervix

Primary outcomes:
measure: prevalence of transgender men who have ever been screened for cervical cancer in their lifetime
timeFrame: At study entry, basline (no follow-up)
Secondary outcomes:
measure: prevalence of transgender men who feel concerned about cervical cancer screening
timeFrame: At study entry, basline (no follow-up)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: ingrid JULIER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030817: 99mTc-CNDG Injection in the Diagnosis of Malignant Tumors
Official title: A Prospective Study to Explore the Performance and Efficacy of 99mTc-CNDG Injection in Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 100
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: DIAGNOSTIC

Brief summary: Currently, 18F-fluorodeoxyglucose (18F-FDG) is the most widely used tumor imaging agent in clinical practice. However, the production of 18F requires accelerators and is associated with relatively high diagnostic costs, which to some extent limits its widespread clinical application. In comparison to Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) devices are more abundant and offer lower diagnostic expenses. With the utilization of Cadmium Zinc Telluride (CZT) crystals in SPECT and advancements in image reconstruction techniques, the resolution and sensitivity of SPECT is continually improving. Therefore, the development of a simplified and cost-effective novel SPECT tumor imaging agent holds significant practical significance. This study involved the design and synthesis of a glucose-derived ligand with a linker containing seven methylene units and an isonitrile group (CN7DG). The CN7DG ligand was labeled with 99mTc to prepare a more lipophilic 99mTc-CN7DG complex, aiming to investigate a novel SPECT imaging agent for tumor imaging.


Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* Patients diagnosed with malignant glioma, colorectal cancer, pancreatic cancer, lung cancer, breast cancer, or other malignant tumors through imaging techniques such as MRI, CT, and ultrasound, and who are scheduled for surgical resection or biopsy
* Solid tumor sizes greater than 2cm
* Voluntarily agree to participate and sign an informed consent form
* Can provide complete surgical records, pathological results, control data, and clinical follow-up results

Exclusion Criteria:

* Pre-treatment such as chemotherapy and targeted therapy has been administered
* Pregnancy and breastfeeding
* Claustrophobia
* The condition is severe and difficult to cooperate with
* Unable to obtain relevant control imaging data and clinical information

Primary outcomes:
measure: Uptake value of 99mTc-CNDG in malignant tumors
timeFrame: through study completion, an average of 1 year
measure: Lesions detected by 99mTc-CNDG SPECT/CT
timeFrame: through study completion, an average of 1 year
measure: Compared with 18F-FDG PET/CT or CECT
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongli Jing
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06117917: Esketamine Combined With Pregabalin on CPSP in Spinal Patients.
Official title: Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients Undergoing Primary Spinal Tumor Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Esketamine
Pregabaline
Chronic Post Operative Pain
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic postsurgical pain has become one of the most common complications of surgery. The quality of life will be impacted once the postsurgical patients are combined with persistent pain. What's more, the postsurgical pain may increase other adverse outcomes. It's important to find a better way to keep the postsurgical patients away from postoperative pain. Esketamine and pregabalin have become potentially effective drugs on CPSP.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing elective primary spinal tumor surgery;
* Ages between 18 and 65 years old;
* American Society of Anaesthesiology (ASA) status I-III;
* Signed informed consent.

Exclusion Criteria:

* Previous adverse reaction to ketamine, s-ketamine or pregabalin;
* Patients with a diagnosed history of severe chronic pain;
* Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
* Patients with aphasia or inability to cooperate with the pain assessments;
* Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
* Patients with a diagnosed history of psychiatric disorder;
* Patients treated with gabapentin/pregabalin in the last three months;
* Drug abuse;
* Body mass index (BMI) \> 35 kg/m2 ;
* Pregnancy or lactation.

Primary outcomes:
measure: the proportion of patients with chronic postsurgical pain during 3 months after operation
timeFrame: 3 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D
role: STUDY_CHAIR
References:
Clinical trial NCT06788717: MDR - Comprehensive Primary Revision Stems PMCF
Official title: Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Shoulder Disease
Shoulder Arthritis
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2025-01-23
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive series of subjects implanted with the Comprehensive Primary Revision Stems according to the approved indications will be identified and invited to participate in the study.

Brief summary: The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.

Detailed description: The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified.

The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.

Eligibility criteria: Inclusion Criteria

* Patient must be 18 years of age or older.
* Patient must be willing and able to follow directions.
* Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem

Exclusion Criteria

* Off-label use.
* Patient is a prisoner.
* Patient is a current alcohol or drug abuser.
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent.
* Patient is unwilling to sign informed consent.
* Uncooperative patient or patient with neurologic disorders who are incapable of following directions.

Primary outcomes:
measure: Implant Survivorship at 10 years follow-up (Kaplan Meier)
timeFrame: 10 years
measure: Frequency and Incidence of Adverse Events (Safety)
timeFrame: 10 years
Secondary outcomes:
measure: Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.
timeFrame: 10 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Zimmer Biomet
name: Ryan Boylan, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05029817: Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters
Official title: Ovarian Reserve in Women With Cystic Fibrosis and the Correlation With Demographic and Clinical Parameters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Infertility, Female
Keywords: Antral follicular count
Anti-Mullerian hormone
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female CF patients seen regularly in the Hadassah Mt. Scopus CF Center, aged 18-45 years old, who regularly attended the clinic, and from whom demographic and clinical parameters are available.

Brief summary: The main objective of this study is to assess the ovarian reserve of CF patients via measurement of AMH and AFC. Secondly, we aim to correlate between the ovarian reserve and demographic and clinical characteristics of these patients.

Outcomes measured will be levels of AMH and AFC, as compared to standard means in the general population. There is no need for a control group in this study since the standardized means of AMH and AFC in the general population are a more accurate comparable measure, which is based on data collected from large-scale populations, and thus accounts for confounding age factor in a more complete manner than can be obtained via a control group (Almog et al., 2011, La Marca et al., 2012, Penzias et al., 2020).


Eligibility criteria: Inclusion Criteria:

* Female patients diagnosed with CF according to genetic testing.
* Age 18-45 years old.
* Routinely attended the CF Center at Hadassah Medical Center.

Exclusion Criteria:

* Refusal to participate in the study.
* Age under 18 or above 45.
* Use of hormonal contraceptives (for the purpose of AFC).

Primary outcomes:
measure: AMH levels
timeFrame: 24 hours
measure: Antral follicular count
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Organization
name: Anat Hershko Klement, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04899817: Granisteron Versus Metoclopramide in Laparoscopic Cholecystectomy
Official title: Efficacy and Safety of Granisteron Versus Metoclopramide as Prophylaxis Antiemetic in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nausea and Vomiting, Postoperative
Keywords: Laparoscopic cholecystectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study aims at comparing the effect of granisteron with that of metoclopramide in patients undergoing lab cholecystectomy

Detailed description: Post operative nausea and vomitting is Avery common complication of laparoscopic surgery in that study we will compare between granisteron and metoclopramide as aprophlaxis against post operative nausea and vomitting

Eligibility criteria: Inclusion Criteria:

* both sexes Age between 18 and 60 years ASA1 2 3 Lap cholecystectomy under general anesthesia

Exclusion Criteria:

* patients refusal Pregnancy and breastfeeding Hepatic or renal disease ASA4 5 Allergy to the drug

Primary outcomes:
measure: Postoperative nausea and vomitting
timeFrame: Every 2 hours for 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital
Study officials:
affiliation: Assiut University
name: Eman M Esmail
role: STUDY_DIRECTOR
References:
Clinical trial NCT00318617: Effect Of GW501516X On How The Heart Obtains And Uses Energy
Official title: A Two Part Study to Separately Evaluate the Effect of 4-week Treatment With GW501516X Relative to Placebo on Cardiac Energetics in a Randomized, Single-blind, Repeat Dose, Parallel Group Design in Healthy Male Subjects
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dyslipidaemias
Heart Failure
Keywords: peroxisome proliferator activated receptors,
PPARs,
Heart Failure,
cardiac energetics,
MRI,
GW501516X
fatty acid metabolism,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-27
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes

Brief summary: The purpose of this study is to determine the effect of a 4-week treatment period with GW501516X on how the heart obtains and uses energy. The energy of the heart will be measured by Magnetic Resonance Imaging (MRI). This study will also measure a number of other potential markers of drug activity, including levels of certain lipids (fats) and proteins in your blood. The data from this study may help researchers better understand the actions of this drug in the body and if this drug may be useful to treat patients with heart disease.


Eligibility criteria: Inclusion criteria:

* Non-smoking.
* Body Mass Index of greater than 27 and less than 32 and who weigh 120 kg (264 lbs) or less and have a waist circumference of greater than 95 cm (37.5 inches).

Exclusion criteria:

* History of muscle disease, coagulation disorders, heart disease or abnormal heart rhythm (or a family history of early coronary artery disease).
* Documented diabetes, hypoglycemia, thyroid disfunction or adrenal disorder.

Primary outcomes:
measure: Energy-related chemicals and heart contraction, determined by MRI measurement of the heart.
Secondary outcomes:
measure: Additional energy-related chemicals, determined by MRI measurement of the heart. Blood proteins. Safety of GW501516X.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: