louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00232024: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Official title: Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Dyspepsia, gastrointestinal, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 1296
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.


Eligibility criteria: Inclusion Criteria:

* Female, 18 years or older
* Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria:

* Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
* Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.

Other protocol-defined inclusion/exclusion criteria may appl

Primary outcomes:
measure: Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
Secondary outcomes:
measure: Average severity score during each week.
measure: Percentage of days with satisfactory relief of dyspepsia during each week.
measure: Weekly global assessment of change in dyspepsia condition.
measure: Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
measure: Quality of life at end of treatment compared to baseline.
measure: Safety and tolerability.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Basel
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT02356224: The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability Study Following Single Dose of SHR3824 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824 Type 2 diabetes mellitus SGLT2
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.


Eligibility criteria: Inclusion criteria:

* Chinese male and female subjects aged 18 to 45 years.
* BMI:18 -25 kg/m2 .
* Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria:

* History of or current clinically significant medical illness as determined by the Investigator.
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
* Pregnancy or breastfeeding .
* Significant acute or chronic medical illness, including renal impairment, or recent surgery.
* Donation of blood or plasma within the 4 weeks prior to the start of the study or acception of blood transfusion within 8 weeks.

Primary outcomes:
measure: Total 24-hour urinary glucose excretion as a measure of pharmacodynamic effect.
timeFrame: 24h after dosing
measure: SHR3824 and its metabolites of concentrations to characterize SHR3824 harmacokinetics.
timeFrame: Up to 72h after dosing
Secondary outcomes:
measure: The number of patients with adverse events as a measure of safety and tolerability
timeFrame: up to day 72h after dosing
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xuhui Central Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT06981624: Comparison of the Systematic Versus the Selective Use of Heparin for the Prevention of Radial Artery Occlusion
Official title: Comparaison d'un Traitement systématique à l'héparine Versus sélectif Pour la prévention de l'Occlusion Radiale EASY-Héparine
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Radial Artery Occlusion
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized study comparing the systematic use of heparin (standard of care) against an elective use of heparin to prevent radial artery occlusion after a percutaneous catheterization using a dual-artery compression system.


Eligibility criteria: Inclusion Criteria:

* Any patient referred for a diagnostic transradial catheterism

Exclusion Criteria:

* Unable to understand study design or provide informed consent
* Unable to receive antiplatelet therapy with aspirina and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant derived from heparine or bivalirudine
* Local condition such as hematoma or pseudo-aneurims precluding radial or ulnar access.
* Presence of plethysmographic waveform with simultaneous radial and ulnar occlusive compression (due to colaterals or interouseous artery) precluding the evaluation of patent hemostasis.

Primary outcomes:
measure: Rates of patent hemostasis
timeFrame: within 24 hours after diagnostic angiography
measure: Time to hemostasis
timeFrame: within 24 hours post-procedure
measure: Nursing time involvement
timeFrame: within 24 hours post-procedure
measure: Evaluation of complications
timeFrame: within 30 days of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: IUCPQ
Study officials:
References:
Clinical trial NCT01957124: Treatment of the Hypertensive Leg Ulcers by PRF Application
Official title: Treatment of the Hypertensive Leg Ulcers by PRF Application
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertensive Leg Ulcer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 10
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: Hypertensive leg ulcers are very painful and difficult to treat ulcers. Their treatment is not well established.

We want to study the efficacy of PRF applications on the pains related to those ulcers.

PRF (Platelet-Rich Fibrin) is an autologous fibrin clot, obtained extemporaneously from patient's blood, without any additive nor complex manipulation. It contains blood platelets and white blood cells, trapped in fibrin during clot formation.

PRF (Platelet-Rich Fibrin) is form immediately after blood punction in a dry tube, that does not contain any anticoagulant. Coagulation naturally occurs within few minutes, and tubes are placed in a centrifuge: red blood cells are separated from the fibrin clot thanks to difference of density, and blood platelets and white blood cells are trapped in the fibrin clot.

The fibrin clot is then rapidly applicated on the ulcer surface for four days. Our hypothesis is that platelet growth factors and cytokines, liberated during platelet activation, could help to treat hypertensive leg ulcers, that are caused by a vascular spasm.

Detailed description: 2 to 8 PRF (depending on the ulcer surface), applied on painful hypertensive leg ulcer, and covered by a dressing for 4 days.

Afterwards, dressings are made in a classical way. If needed (persistence of important pain), the PRF application can be repeated after 7 days.

Eligibility criteria: Inclusion Criteria:

* hypertensive leg ulcer
* important pain (\>= 5/10)

Exclusion Criteria:

* significant venous deficiency
* significant arterial deficiency
* other leg ulcers
* any active diseases such as infection, neoplasia, auto-immune disease

Primary outcomes:
measure: Pain auto evaluation (spontaneous and caused by local care)
timeFrame: Pain was assessed by self-assessment Single Digital Scale - Pain felt in the past 24 hours;
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Hôpitaux Universitaires
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Jean-Nicolas Scrivener
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01112124: Behaviors of Children Ages 15 Months to Five Years Around Microwave Ovens
Official title: Behaviors of Children Ages 15 Months to Five Years Around Microwave Ovens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scald Burn Injuries
Keywords: Typical
Development
Microwave
Children
Behavior
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Typically developing children ages 15 months to 5 years born full term

Brief summary: The purpose of this study is to assess the typical behavior of children ages 15 months to five years around a microwave oven. The UCH Burn and Complex Wound Center has observed scald burn injuries in young children operating and/or removing hot liquids from microwave ovens. The knowledge we hope to gain is the developmental age that a child is able to open and/or operate a microwave oven safely. This work may influence future microwave oven design to protect young children from microwave-related scald burn injuries. These injuries have resulted in visits to the emergency room, stays in the hospital and debridement and skin grafting procedures in the operating room.


Eligibility criteria: Inclusion Criteria:

* a microwave oven in the child's home environment,
* age appropriate development,
* intact visual acuity, and
* English speaking.

Exclusion Criteria:

* developmental delay,
* non-English speaking.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Lawrence J Gottlieb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029224: Treatment With Zoledronic Acid in Patients With Breast Cancer, Multiple Myeloma, and Prostate Cancer With Cancer Related Bone Lesions
Official title: A Prospective, Multicenter, Open-label Clinical Evaluation of the Effect of IV Zoledronic Acid 4mg on PAIN, QUALITY OF LIFE and TIME IN INFUSION CHAIR in Breast Cancer, Multiple Myeloma, and Prostate Cancer Patients With Cancer-related Bone Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Multiple Myeloma
Prostate Cancer
Keywords: bone lesions
breast cancer
multiple myeloma
prostate cancer
bone metastases
pain
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2002-01-10
Enrollment: 500
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: Patients with bone metastases or bone lesions caused by breast cancer, multiple myeloma or prostate cancer will be treated with IV Zometa in a 15 minute infusion. Pain will be evaluated, as well as time in chair, quality of life and safety of Zometa.


Eligibility criteria: Inclusion Criteria

* Signed informed consent
* Greater than 18 years of age
* Proof of breast cancer, multiple myeloma or prostate cancer
* Diagnosis of at least one cancer-related bone lesion
* If patient is of child-bearing potential, negative pregnancy test and on a medically recognized form of contraception
* ECOG performance status of 0,1 or 2
* Ability to read, understand and write English or Spanish language
* Normal renal function
* Corrected serum calcium equal to or greater than 8mg/dl Exclusion Criteria
* clinically symptomatic brain metastases
* hypersensitivity to Zometa or other bisphosphonates
* pregnant or lactating

Primary outcomes:
measure: Pain score assessed by change from baseline
Secondary outcomes:
measure: Quality of life
measure: Time in infusion chair
measure: Safety assessed by adverse events (AEs)
Other outcomes:
Locations:
city: Stockton
country: United States
facility: Stockton Hematology Oncology Medical Group
state: California
city: Kissimmee
country: United States
facility: Osceola Cancer Center
state: Florida
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: Albuquerque
country: United States
facility: Hematology-Oncology Associates PC
state: New Mexico
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants
state: New Mexico
city: Medforo
country: United States
facility: Hematology Oncology Associates, PC
state: Oregon
city: Richmond
country: United States
facility: Virginia Physicians, Inc
state: Virginia
Study officials:
References:
Clinical trial NCT04531124: Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives
Official title: Cardiovascular and Renal Outcomes of Integrated Management of Blood Pressure and Other Cardiometabolic Risks in Hypertensives：a Multicenter Prospective Cohort Study （UPDATE-cohort）
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiovascular Risk Factor
Hypertension
Renal Disease
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients with hypertension in different levels of hospitals in Shanghai, China

Brief summary: this clinical trial is designed to study the cardiovascular and renal outcomes of hypertensives after an integrated management of blood pressure and other cardiometabolic risks. it is a multicenter prospective cohort study.


Eligibility criteria: Inclusion Criteria:

1. Outpatients from departments of Cardiology, Endocrinology, Nephrology, Neurology, Geriatrics or General Internal Medicine.
2. Diagnosed as hypertension. Diagnostic criteria: 1)The office BP measured at the day of visit and at least one time before that day were above the cut-off values ( ≥140 mmHg SBP and/or ≥90 mmHg DBP); 2)for patients with normal BP at the day of visit, they should have already been given pre-treatment with antihypertensive drugs ≥ 2 weeks.
3. Voluntary participation.

Exclusion Criteria:

1. Patients aged\< 18 years old.
2. Patients without a definite diagnosis of hypertension(for instance, if the patient has been taking antihypertensive drugs irregularly, it is difficult to confirm the diagnosis of hypertension).
3. Patients with a definite diagnosis of secondary hypertension.
4. Patients are diagnosed dyslipidemia with clear cause, such as nephrotic syndrome, severe hypothyroidism, terminal stage of malignancy, etc.
5. Patients are diagnosed end-stage renal disease, hemodialysis, and peritoneal dialysis patients.
6. Patients diagnosed with mental abnormalities who are unable to complete the questionnaire.
7. Patients have once participated in this research during this study cycle(to avoid repeated participation).

Primary outcomes:
measure: complex outcome
timeFrame: follow-up 1 year
measure: coronary angioplasty
timeFrame: follow-up 1 year
measure: acute renal failure
timeFrame: follow-up 1 year
measure: acute heart failure
timeFrame: follow-up 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: HuashanH
state: Shanghai
Study officials:
References:
Clinical trial NCT01679834: An Observational Study of Pegasys in Dual- or Triple-Therapy in Patients With Chronic Hepatitis C
Official title: A Roche Project in Cooperation With the Bng (Association of German Resident Gastroenterologists) for Quality Assurance in the Dual- or Triple-therapy of Chronic Hepatitis C With Peg-(40kd)-Interferon Alfa 2a (Pegasys) at Hepatology Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-06
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C infection

Brief summary: This multicenter, observational study will assess the efficacy and the safety of Pegasys (peginterferon alfa 2a) in dual- or triple therapy in patients with chronic hepatitis C. Patients will receive Pegasys and/or ribavirin and/or a protease inhibitor according to local guidelines. Data will be collected for 96 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of chronic hepatitis C
* Patients receiving treatment with Pegasys and/or Copegus (ribavirin) and/or a protease inhibitor according to local label

Exclusion Criteria:

* Contraindications against Pegasys or Copegus
* Not willing or unable to sign written informed consent form

Primary outcomes:
measure: Sustained virological response
timeFrame: 24 weeks after end of treatment
Secondary outcomes:
measure: Rapid virological response
timeFrame: 4 weeks after start of treatment
measure: Early Virological Response
timeFrame: 12 weeks after start of treatment
measure: Safety: incidence of adverse events
timeFrame: up to 24 weeks after end of treatment
Other outcomes:
Locations:
city: Hannover
country: Germany
city: Herne
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05876234: The Predictive Value of Progesterone
Official title: The Predictive Value of the Progesterone Level on the Day of Embryo Transfer in Cryo Cycles
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Subfertility
Keywords: progesterone
embryo transfer
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Treated at Ghent University Hospital

Brief summary: To evaluate a 5 ng/ml serum progesterone (P4) threshold policy for the addition of subcutaneous (SC) P4 in artificially prepared frozen embryo transfer cycles treated with vaginal P4. We assess whether the addition of SC P4 rescues cycles with serum P4 \<5 ng/ml and we study the impact of not supplementing cycles with serum P4 \>5 ng/ml by comparing them with serum P4 cycles above the conventionally proposed cut-off of 10 ng/ml.


Eligibility criteria: * Embryo transfer between March 1st 2021 and March 31st 2023
* Determination of progesterone on the day of embryo transfer

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 11 to 13 weeks after last menstruation
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6 to 8 weeks after last menstruation
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Department of Reproductive Medicine
Study officials:
affiliation: University Hospital, Ghent
name: Dominic Stoop, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676934: End Tidal Control of Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia of Living Donor Hepatectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: the study compares the use of end tidal (Et) control of sevoflurane during anesthesia for living donor hepatectomy versus fresh gas (FGF) control. Et control is hypothesized to be as effective as FGF control with less cost and more operator satisfaction.


Eligibility criteria: Inclusion Criteria:

* all donors scheduled for living donor hepatectomy in Mansoura liver transplant program

Exclusion Criteria:

* refusal

Primary outcomes:
measure: cost of sevoflurane during anesthesia
timeFrame: Intra-operative period
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahleya
Study officials:
References:
Clinical trial NCT03408834: The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese Patients
Official title: The Effect of Fluid Management by Pleth Variability Index on Acute Kidney Injury in Obese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Colorectal Surgery
Acute Kidney Injury
Keywords: NGAL
PVI
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatin in renal ischemic injury, was used.

Detailed description: Our object in this study was to find out whether laparoscopic colorectal surgery is detrimental to the kidneys via PVI monitoring. To detect the kidney injury, so-called kidney troponin NGAL ,which gives earlier information than creatine in renal ischemic injury, was used.

Patients undergoing elective laparoscopic colorectal surgery, 18 to 75 years old, planned surgery duration longer than 2 hours, were included in this study. Patients were divided into 2 groups with respect to their fluid resuscitation, Group 1: goal directed fluid therapy via PVI monitoring Group 2: conventional fluid resuscitation. Blood samples were drawn from both groups for NGAL measurement before CO2 insufflation (T0), and at 6th(T1) and 12th(T2) hours after CO2 insufflation. At the end of the surgery, sugammadex was given to all patients for reversal of muscular blockade.

Eligibility criteria: Inclusion Criteria:

* laparoscopic surgery
* obese patient

Exclusion Criteria:

* patient refusal
* major comorbidity
* renal failure
* diabetes mellitus

Primary outcomes:
measure: Diagnosis of acute kidney injury
timeFrame: postoperative 6 th hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: CIGDEM YILDIRIMGUCLU
role: STUDY_CHAIR
References: