louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00383916: Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.
Official title: An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-04
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study comparing 2 different investigational formulations of pantoprazole in healthy adults.

Detailed description: open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study

Eligibility criteria: Inclusion Criteria

* Men or women aged 18 to 50 years.
* Healthy as determined by the investigator.

Exclusion Criteria

* History or active presence of clinically important medical disease.
* History of drug or alcohol abuse.

Primary outcomes:
measure: To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.
Secondary outcomes:
measure: To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06583616: The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism
Official title: The Prognostic Value of Anion Gap in Predicting Mortality Among Patients With Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pulmonary Embolism (PE)
Keywords: anion gap
acute pulmonary embolism
mortality
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient with acute pulmonary embolism

Brief summary: This study aims to evaluate the prognostic value of the anion gap in predicting mortality among patients with acute pulmonary embolism.

Researchers will collect information based on hospital registry as secondary data of in patient who had diagnosed as acute pulmonary embolism by using computed tomography scan (CT scan). The data consist of demographic data, clinical presentation, laboratory, and CT scan were collected from hospital registry by reviewing medical record. Then, the data was analyzed by using IBM SPSS Statistics v26.


Eligibility criteria: Inclusion Criteria:

* age: 18 - 70 years old
* patient with acute pulmonary embolism

Exclusion Criteria -- patient with history of:

* heart failure
* valvular heart disease
* chronic obstructive pulmonary disease
* congenital heart disease
* sepsis
* chronic kidney disease

Primary outcomes:
measure: In-hospital mortality
timeFrame: During hospitalization, up to 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Of Java
Study officials:
References:
Clinical trial NCT05655416: Treatment of Great Saphenous Vein Varicosities
Official title: Endovenous Chemical Ablation and Trendlenburg Operation for the Treatment of Great Saphenous Vein Varicosities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-12-19
Enrollment: 55
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Venous insufficiency at lower extremities may result in clinical problems from cosmetic issues to ulcerations. When the frequency of venous insufficiency and its related problems are considered besides their diversity, it is encountered as a public health issue. This pathology is reported to affect 40% of women and 20% of men.1 Patients with varicose veins may complain of unsightly appearance, aching, heaviness, pruritus, and early fatigue of the affected leg. These symptoms worsen with prolonged standing and sitting and are relieved by elevation of the leg above the level of the heart. Also, mild edema is often present. More severe signs include thrombophlebitis, hyperpigmentation, lipodermatosclerosis, ulceration, and bleeding


Eligibility criteria: Inclusion Criteria:

* Patients presented by primary VV of the LL complaining of Leg pain cosmetic disfigurement, leg ulcer, itching, or pigmentation at LL
* the incompetence of the saphenofemoral junction (SFJ) and or saphenopopliteal junction (SPJ).

Exclusion Criteria:

* Lower limb involvement by any of the following conditions; secondary VV, recurrent VV, lymphedema, acute superficial thrombophlebitis, arterio-venous fistula (congenital or acquired), congenital anomalies of the venous system, general comorbidities, skin infection or ischemia

Primary outcomes:
measure: GSV Patency
timeFrame: at one week post operative
measure: GSV Patency
timeFrame: at one month post operative
measure: GSV Patency
timeFrame: at one year post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Walied Khereba
Study officials:
References:
Clinical trial NCT00697424: Comparison of Breathing Events Detected by the SleepStyle 200 Auto Continuous Positive Airway Pressure (CPAP) Device to Attended Polysomnography
Official title: Investigation of Methods to Detect Respiratory Irregularities in Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Obstructive Sleep Apnoea (OSA) is a common sleep-breathing disorder affecting around 2-4% of the population and is characterised by loud snoring, periodic collapse of the upper airway particular to sleep, sleep fragmentation, and sometimes daytime sleepiness. Health consequences include impaired cognitive functioning, quality of life, mood, and increased cardiovascular disease risk. Epidemiological studies have demonstrated that increased morbidity and mortality in a dose response manner with increasing severity of sleep disordered breathing.

The standard treatment for OSA is nasal Continuous Positive Airway Pressure (CPAP), which consists of pressurized air applied to the nose via a mask. Generally a single, optimal pressure is prescribed for a patient based on a full night or partial night study during which the pressure is adjusted by a technician until all sleep disordered breathing (SDB) events are abolished. Despite therapy efficacy, compliance to CPAP therapy is sub-optimal.

Due to low compliance it has become common for healthcare providers to follow up subject therapy efficacy through reporting software inherent in many current CPAP devices. Healthcare providers can use this reported data to make appropriate treatment decisions. For this reason the data needs to be accurate. The SleepStyle™ 200 Auto Series CPAP humidifier is an auto adjusting CPAP which stores comprehensive compliance data. The aim of this study is to compare the reliability of the SleepStyle™ 200 Auto Series CPAP data to laboratory-based PSG in detecting sleep disordered breathing.

Hypothesis: The SleepStyle™ 200 Auto Series reporting features accurately detects indices of sleep disordered breathing.


Eligibility criteria: Inclusion Criteria:

* Apnea Hypopnea Index (AHI) \>15 from diagnostic night
* ≥18 years of age

Exclusion Criteria:

* Contraindicated for CPAP use

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: At the end of the sleep study.
Secondary outcomes:
measure: Respiratory Disturbance Index (RDI)
timeFrame: At the end of the sleep study (PSG)
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Hospital, Adult Sleep & Ventilation Service, Auckland City Hospital
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Jessica R Hayward, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02644616: The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tricuspid Regurgitation
Right Heart Failure
Keywords: tolvaptan
safety and efficacy
left heart valves replacement
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators research the early improvement of fluid retention and mid-term prognosis through the administration of tolvaptan for the patient with tricuspid regurgitation and right heart failure after left heart valves replacement.


Eligibility criteria: Inclusion Criteria:

1. Patient with tricuspid regurgitation and right heart failure after left heart valves replacement
2. Patients who takes existing diuretic
3. The patient is willing to participate in the study

Exclusion Criteria:

1. Patients with hypersensitivity to study drug
2. Anuric patients
3. Patients with hypernatremia
4. Female patients who are pregnant, possibly pregnant, or lactating, or who plan to become pregnant
5. Malignant tumor
6. Patients with serious hepatic disorder or Serious Renal failure
7. Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the study

Primary outcomes:
measure: The change of all the subjects'liquid intake and output volume change after a period(10 days) of treatment
timeFrame: 2015.01-2017.12
Secondary outcomes:
measure: A cumulative urine volume for 72 hours (all subjects)
timeFrame: 2015.01-2017.12
measure: Echocardiography results VS the baseline results(all subjects)
timeFrame: 2015.01-2017.12
measure: Change of right heart failure signs(all subjects)
timeFrame: 2015.01-2017.12
measure: Onset of cardiovascular event (all subjects)
timeFrame: 2015.01-2017.12
measure: Onset of serious adverse event(all subjects)
timeFrame: 2015.01-2017.12
measure: other adverse events(all subjects)
timeFrame: 2015.01-2017.12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: FangYuan
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Fang Yuan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan F, Wu Z, Jiang L, Zhou J, Xu L, Liu H, Ma L, Zhai Z, Zhang J. Short-Term Effects of Tolvaptan in Tricuspid Insufficiency Combined with Left Heart Valve Replacement-Caused Volume-Overload Patients: Results of a Prospective Pilot Study. Am J Cardiovasc Drugs. 2019 Apr;19(2):211-218. doi: 10.1007/s40256-018-0304-1.
Clinical trial NCT02973724: EC95 of Remifentanil for Preventing Cough
Official title: Predicted EC95 of Effect-site Concentration of Remifentanil for Preventing Cough After Laryngomicrosurgery From Propofol Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Usage
Keywords: Extubation
Remifentanil
Laryngomicrosurgery
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator designed this study to investigate remifentanil effect-site concentration in 95% of patients (EC95) for preventing cough after laryngomicrosurgery from propofol anesthesia.

Detailed description: At the end of the surgery, propofol infusion was stopped and remifentanil was titrated to predetermined (initial concentration 1.0 ng/ml for the first patient). Extubation was performed when the patients opened their eyes and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for laryngomicrosurgery

Exclusion Criteria:

* Anticipated difficult airway
* COPD, Asthma
* Recent URI (\< 2 weeks)
* Severe cardiac, hepatic renal disease

Primary outcomes:
measure: Number of cough
timeFrame: from end of surgery to 5 min after tracheal extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT02643524: Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
Official title: Weight Change With Controlled Ankle Movement (CAM) Walker Boot Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Injury
Ankle Injury
Keywords: Adult
CAM boot
controlled ankle movement
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 20
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 the study is to determine if patients wearing a CAM walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercise information.

Detailed description: The study objectives are: (1) Determine if patients wearing a CAM (Controlled Ankle Movement) walker boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional and upper body exercises (gender appropriate) information at the time the CAM boot is dispensed; and (2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period.

Eligibility criteria: Inclusion Criteria:

* Age greater or equal to 18 (male or female)
* Participants prescribed a CAM boot as standard of care from the study investigator's practice
* Participant willing to have weight measured at the clinic site at time of enrollment and final visit
* Participants willing to have blood drawn for Albumin level at beginning and end of study
* Participant is able to provide voluntary, written informed consent
* Participant, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits.
* Fluent in written and spoken English

Exclusion Criteria:

* Participants less than 18 years of age
* Pregnant women
* Cognitive impairment
* Participants with vertigo or other balance issues
* Participants unable to provide informed consent
* Non-English speaking individuals
* Participants who will not be wearing a CAM boot for at least 6 weeks
* Participants unable/unwilling to perform upper body exercises and follow nutrition guidelines

Primary outcomes:
measure: Weight change
timeFrame: Enrollment through release by Doctor to discontinue CAM Boot, an average of 12 weeks
Secondary outcomes:
measure: Nutritional status (Pre- and post-albumin levels)
timeFrame: Enrollment through study completion, an average of 12 weeks.
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Nell Blake, DPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00971724: Biomarkers of Prednisolone Treatment (P05888)
Official title: A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Hyperglycemia
Glucose Intolerance
Keywords: Prednisolone
Glucocorticoids
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 72
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

* To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

* To describe the PK of prednisolone and PD of a series of biomarkers.
* To identify biomarkers that reflect side effects of prednisolone.
* To elucidate part of the mechanisms by which prednisolone induces metabolic changes.


Eligibility criteria: Inclusion Criteria:

* 22 \< BMI \< 30
* fasting glucose \< 5.6 mmol/L and glucose \< 7.8 mmol/L 2hr after OGTT
* able and willing to sign informed consent
* history of good physical and mental health
* subject smokes less than 5 cigarettes per day
* able to keep a normal day and night rhythm

Exclusion Criteria:

* allergy to prednisolone
* glucocorticoid use during last 3 months prior to study
* use of any drug or substance
* history of familiar diabetes type 2
* clinically relevant history or presence of any medical disorder
* clinically relevant abnormal lab or ECG
* positive drug or alcohol screen, positive hepatitis B or C surface antigen
* donation of blood (\>100 mL) within 90 days prior to the first dose

Primary outcomes:
measure: To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone
timeFrame: Day 1 and day 15
Secondary outcomes:
measure: To describe the PK of prednisolone and PD of a series of biomarkers
timeFrame: Day 1 and day 15
Other outcomes:
Locations:
Study officials:
References:
citation: Ellero-Simatos S, Szymanska E, Rullmann T, Dokter WH, Ramaker R, Berger R, van Iersel TM, Smilde AK, Hankemeier T, Alkema W. Assessing the metabolic effects of prednisolone in healthy volunteers using urine metabolic profiling. Genome Med. 2012 Nov 30;4(11):94. doi: 10.1186/gm395. eCollection 2012.
citation: Toonen EJ, Fleuren WW, Nassander U, van Lierop MJ, Bauerschmidt S, Dokter WH, Alkema W. Prednisolone-induced changes in gene-expression profiles in healthy volunteers. Pharmacogenomics. 2011 Jul;12(7):985-98. doi: 10.2217/pgs.11.34. Epub 2011 Jun 2.
Clinical trial NCT00395616: Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type A Botulinum Toxin
Tennis Elbow
Lead sponsor: E-DA Hospital
Sponsor class: OTHER
First posted: 2006-11-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis elbow has a direct impact on the workplace productivity and quality of life. Steroid injection is the very few methods proved to have short-term efficacy in tennis elbow treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of muscle after botulinum toxin injection may reduce the physical demands and facilitate the normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin injection is effective in treating tennis elbow. The objective of this study is to compare the effects of botulinum toxin injection with corticosteroid injection in tennis elbow treatment.


Eligibility criteria: Inclusion Criteria:

* Pain at the lateral epicondyle of the elbow
* Tenderness at the lateral epicondyle of the elbow
* Pain on resisted extension of the wrist

Exclusion Criteria:

* Local injection of steroid within 3 months
* Previous elbow trauma or operations
* Pregnancy
* Systemic neuromuscular disorders such as myasthenia gravis

Primary outcomes:
measure: WHOQOL-BREF
measure: visual analogue scale for pain
measure: grip strength
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung,
country: Taiwan
facility: E-Dah Hospital
Study officials:
affiliation: E-Dah Hospital, Kaohsiung, Taiwan
name: Yu-Ching Lin, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03592524: Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation
Official title: Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation: Single Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplantation
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent Living donor liver transplantation

Brief summary: The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).

Detailed description: Very limited data in the literature about how to apply Ramadan fasting in the post liver transplant setting. The timing of Ramadan is changeable according to the lunar year and according to time of down and sunset in each country. In Egypt, for example, Ramadan fasting this year started 17th of May and finished 14th June with average fasting hours of 15-16 hours The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after LT.This prospective study included 45 recipients who underwent LT at Ain Shams Center for Organ Transplant (ASCOT), Cairo, Egypt.

Eligibility criteria: Inclusion Criteria:

* • Recipients completed their first year after LDLT

  * Normal liver and renal functions at least in the last 3 months before fasting
  * No reported rejection episodes in the last 6 months before the study
  * Recipients wishing to fast Ramadan
  * Informed consent about the study

Exclusion Criteria:

* • First year of LDLT

  * Recipients transplanted for Budd Chiari syndrome
  * Recipients with vascular stents (hepatic artery , portal vein or hepatic vein stents) requiring long life anticoagulation
  * Creatinine clearance \<60 ml/min or serum creatinine \>1.5 mg/dl at time of initial enrolment in the study.

Primary outcomes:
measure: Effect of fasting on Allograft function among recipients post liver transplantation
timeFrame: 1 month
measure: Effect of fasting Ramadan on renal functions among recipients post liver transplantation
timeFrame: 1 month
measure: Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients
timeFrame: 1 month
Secondary outcomes:
measure: Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs
timeFrame: 1 month
measure: Effect of fasting Ramadan on blood sugar control among diabetics recipients
timeFrame: 1 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Iman Montasser
Study officials:
References: