louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00931710: Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension
Official title: A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stage 2 Systolic Hypertension
Keywords: Hypertension
combination therapy
valsartan
cardiovascular diseases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 488
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 compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).


Eligibility criteria: Inclusion Criteria:

* Male or female outpatient of 18 years of age or greater
* Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and \< 200 mmHg at randomization
* Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria:

* Office systolic blood pressure \>200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
* Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
* Refractory hypertension, defined as blood pressure \>140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
* Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks
timeFrame: Baseline to Week 6
measure: Cumulative Percentage of Patients Achieving Blood Pressure Control
timeFrame: 3 and 6 weeks
measure: Cumulative Percentage of Treatment Responders
timeFrame: 3 and 6 weeks
measure: Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks
timeFrame: Baseline to week 12
measure: Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit
timeFrame: 3, 6, 9 and 12 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: sites in USA
state: New Jersey
Study officials:
affiliation: 862-778-8300
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06334081: Different Surgical Drilling Protocols in Posterior Maxilla
Official title: Clinical Outcomes of Two Different Surgical Drilling Protocols of Immediate Loaded Dental Implant in Posterior Maxilla
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Missing Teeth
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixteen dental implants inserted in sixteen patients who were selected from the outpatient clinic of the Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Mansoura University, for the rehabilitation of missed single maxillary posterior tooth by an immediately loaded dental implants

Detailed description: 16 dental implants were inserted in 16 patients were divided into two groups: Group A: 8 dental implants were inserted using undersized drilling technique and Group B: 8 dental implants were inserted using single drilling technique. then the dental implants were assessed for 6 months regarding

Clinical Evalution: regarding these parameters after immediately dental implants loading,3 months and 6 months.

implant stability, implant probing depth, bleeding index.

Radiographic evaluation: immediately after implant loading and 6 months after loading regarding bone density and marginal bone loss.

Eligibility criteria: Inclusion Criteria:

* Patients with missed one or more posterior maxillary tooth.
* Be older than 18 years and of residual bone height more than10 mm.
* Patients with good oral hygiene and willing to participate in the follow-up sessions.
* Patients with adequate mesio-distal width and inter-arch space.
* Patients without any para-functional habits such as clenching and bruxism.

Exclusion Criteria:

* Patients whose proposed surgical site had any pathological lesion or root tips.
* Drug or alcohol abuse.
* Patients with uncontrolled systemic diseases.
* Pregnant patients.
* Tobacco use more than fourteen cigarettes daily.

Primary outcomes:
measure: bone density measurement
timeFrame: 6 month
measure: marginal bone loss
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Heba Elsheikh
Study officials:
References:
Clinical trial NCT06673381: High Sensitive C-reactive Protein to Albumin Ratio in Acute Coronary Syndrome
Official title: Prediction of Acute Coronary Syndrome In-hospital Major Adverse Cardiovascular Events by High Sensitivity C- Reactive Protein to Albumin Ratio
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Coronary Syndrome
Keywords: high sensitive c-reactive protein to albumin ratio
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It included patients with ACS diagnosed according to AHA/ACCF guidelines according to symptoms, ECG findings and serum troponin levels), who had admitted to the CCU.

Brief summary: assess the use of hs- C-reactive protein to albumin ratio (hs-CAR) in prediction of in-hospital short-term major adverse cardiac events (MACEs) in acute coronary syndrome (ACS) patients

Detailed description: Observational study conducted at coronary care unit(CCU) in sohag university hospital It included patients with ACS diagnosed according to AHA/ACCF guidelines (according to symptoms, ECG findings and serum troponin levels), who had admitted to the CCU.

Venous blood samples were instantly collected on admission to the hospital. hs-CRP , serum albumin level were measured.

hs-CAR is calculated and the patients divided into two groups: Group A ( patients with high hs-CAR) and group B ( patients with low hs-CAR) In-hospital MACE was regarded as the end point of our study. It was defined as acute heart failure, cardiogenic shock, reinfarction, all-cause death, serious arrhythmia and cardiac death

Eligibility criteria: Inclusion Criteria:

* All patients aged 18 Year or older presented by ACS not candidet for primary percutaneus coronary intervention ( PCI ) .

Exclusion Criteria:

* • Patients aged \< 18 years old

  * Patients who have eGFR \<60 ml/kg /m2
  * Patients who have malignancies
  * Patients who have chronic heart failure (NYHA class \>II)
  * Pateints who have chronic liver disease
  * Patients who have nephrotic syndrome
  * Patients who have acute cerebrovascular stroke
  * Pregnant women
  * Patients who have recent infection

Primary outcomes:
measure: assess the use of hs- C-reactive protein to albumin ratio (hs-CAR) in acute coronary syndrom patients
timeFrame: at time of admission in hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Sohag University
name: Amira Elbasuony, resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00621881: A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
Official title: A Phase 1, Repeated-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750 mg Bid Administered to Patients With Impaired Hepatic Function Compared to Matching Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Disease
Keywords: hepatic impairment
Lead sponsor: NicOx
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.

Detailed description: This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.

Eligibility criteria: Inclusion Criteria:

* Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
* Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria:

* Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
* History of renal impairment
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
* Clinically relevant abnormal ECG
* Alcohol or drug abuse within the last 6 months
* Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations

Primary outcomes:
measure: To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
timeFrame: 8 days
Secondary outcomes:
measure: To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.
timeFrame: 8 days
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
Study officials:
References:
Clinical trial NCT06928181: Effects of Passive Blood-Flow-Restriction on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
Official title: Effects of Passive Blood-Flow-Restriction Training on Muscle Atrophy and Pain After Elective Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis in the Knee
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigated the effects of passive Blood-Flow-Restriction Training after elective Total Knee Arthroplasty Surgery on Muscle Atrophy and Postoperative Pain.

Detailed description: This is the first study invesigating the effects of passive Blood-Flow-Restriction Training on Muscle Atrophy and Postoperative Pain after Elective Total Knee Arthroplasty Surgery.

Eligibility criteria: Inclusion Criteria:

* The study includes all patients with a medical indication for surgical treatment of the lower extremity (total or partial knee arthroplasty) who are eligible for either inpatient or outpatient rehabilitation.
* All participating patients have signed the informed consent form for study participation as well as the data protection declaration after receiving comprehensive explanation, counseling, and information.
* All patients have consented to the surgical procedure and received medical clearance for surgery from both the orthopedic and anesthesiology departments.

Exclusion Criteria:

* Acute or chronic infections of the extremities
* Open wounds on the lower extremity
* Pregnancy and breastfeeding
* Patients who are unable to understand the patient information and study design (e.g., due to language barriers), or whose compliance is deemed insufficient by the study team

Primary outcomes:
measure: Muscle Mass
timeFrame: Three Months
measure: Postoperative Pain
timeFrame: Three Months
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
state: NRW
Study officials:
References:
Clinical trial NCT00532181: Micro-Health Insurance in Cambodia
Official title: A Randomized Control Trial of Micro-Health Insurance in Cambodia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Health Insurance Sale
Health Utilization
Asset Sales, Investment and Saving Behaviors
Keywords: Health insurance
Health utilization rates
Saving Behavior
Risk aversion
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: French Development Agency
name: United States Agency for International Development (USAID)
First posted: 2007-09-20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: People who buy insurance are sicker and/or more risk averse than those who don't. Also, Micro-health insurance increases utilization of public health care facilities and protects against asset sales.

Detailed description: Randomly assign coupons giving a discounted price for insurance. Since coupon receipt is exogenous, use these coupons as an instrument for take-up of insurance.

Eligibility criteria: Inclusion Criteria:

* Must be in a village where the health insurance program is being offered.

Primary outcomes:
measure: Better Understand Health Utilization Behavior in Cambodia
Secondary outcomes:
measure: Better Understand asset sales, investment and saving behaviors
Other outcomes:
Locations:
city: Phenom Phen
country: Cambodia
facility: Sky Health Insurance
Study officials:
affiliation: University of California, Berkeley
name: David Levine, PhD Econ
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02571881: Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
Official title: Opioid Induced Bowel Dysfunction in Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Constipation
Pain, Postoperative
Keywords: constipation
oxycodone
caesarean section
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Admescope Ltd
First posted: 2015-10-08
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Constipation is common in pregnant women. Surgery, anaesthesia and opioid analgesics may further impair bowel function. The aim of the present study was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced bowel dysfunction in patients undergoing caesarean section.


Eligibility criteria: Inclusion Criteria:

* • elective caesarean section in spinal anaesthesia

  * normal full term single pregnancy
  * age 18 years or more
  * BMI 20 - 35 kg/m2
  * written informed consent obtained

Exclusion Criteria:

* • not normal or full term pregnancy

  * age less than 18 years
  * allergy to study drugs
  * substance misuse other contraindication to used study drugs no informed consent

Primary outcomes:
measure: Number of patients with opioid induced bowel dysfunction assessed with bowel function index
timeFrame: time from the first drug intake up to three weeks postoperatively
Secondary outcomes:
measure: Oxycodone concentrations in maternal plasma
timeFrame: time before the first drug intake to the day when patient leaves the hospital up to maximum of seven days postoperatively
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savo
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01382381: Intravascular Stents Fracture Effects
Official title: Evaluation of Implanted Aortic Arch and Branch Pulmonary Artery Stents Durability and Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Durability of Implanted Intravascular Stents
Hemodynamic Effect of Implanted Intravascular Stents
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 20
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis will be recruited for the study from our out-patients follow-up clinic

Brief summary: The goal of the study is to evaluate long term durability and hemodynamic effect of implanted stents in the aortic arch and in pulmonary artery branches.

Detailed description: Patients who underwent trans-catheter implantation of balloon expanded stents in the aortic arch and in branch pulmonary arteries will be evaluated by physical examination with blood pressure values measurement of upper and lower limbs.

Echo-Doppler cardiography will be performed for flow velocity analysis. Zoomed fluoroscopy will be performed and recorded in two orthogonal views to evaluate stent integrity or stent fracture.

It is our intention to include 20 patients in this study from our follow-up clinic.

Eligibility criteria: Inclusion Criteria:

-patients who underwent stent implantation for coarctation of the aorta and for branch pulmonary artery stenosis

Exclusion Criteria:

-Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06907381: Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury
Official title: Blood Flow-restricted Resistance Exercise to Promote Muscle Strength and Use in Adults With Incomplete Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Spinal Cord Injury Cervical
Keywords: Blood flow-restricted resistance exercise
Physical therapy
Rehabilitation
Electrical stimulation
Lead sponsor: Quality Living, Inc.
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will include adults with incomplete cervical spinal cord injury. They will be medically stable and enrolled in Quality Living's rehabilitation program in Omaha, NE, at the time of participation. Level of injury can vary from C3 to C8. Participants will demonstrate sensory and motor function consistent with AIS B, C, or D classification.

Brief summary: Recovery of arm and hand motor control is critical for independence and quality of life following incomplete spinal cord injury (iSCI). Blood flow-restricted resistance exercise (BFRE) has emerged as a potential treatment addressing this need, but treatment guidelines and research reporting effectiveness are sparse. The purpose of this work is to provide case reports of people with cervical iSCI who use BFRE supplemented by electrical stimulation (ES) to increase the strength and functional use of selected upper extremity muscles.


Eligibility criteria: Inclusion Criteria:

* Incomplete cervical spinal cord injury
* Resting blood pressure between 80/50 mmHg and 150/90 mmHg for at least three consecutive days
* Native speaker of English

Exclusion Criteria:

* Recent history of deep vein thrombosis or cardiovascular disease including uncontrolled hypertension or a blood-clotting disorder
* Routine experience of orthostatic hypotension as defined as a drop in systolic/diastolic blood pressure greater than 20/10 mmHg when engaging in physical activity
* Severe cognitive, communication, or behavioral disorder as determined by treatment team

Primary outcomes:
measure: Change in muscle strength
timeFrame: Baseline and end of treatment at a maximum of 6 months
Secondary outcomes:
measure: Change in number of repetitions of unassisted target muscle(s) contractions
timeFrame: Baseline and end of treatment at a maximum of 6 months
measure: Change in support required to perform functional task
timeFrame: Baseline and end of treatment at a maximum of 6 months
measure: Change in perceived exertion when performing a functional task
timeFrame: Baseline and end of treatment at a maximum of 6 months
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Quality Living, Inc.
state: Nebraska
Study officials:
affiliation: Quality Living, Inc.
name: Sara Waid, DPT
role: PRINCIPAL_INVESTIGATOR
References: