louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00618228: Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-02-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant finding on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enyzme altering drugs.
* History of allergic or adverse response to balsalazide, mesalamine, salicylates, or other related drugs.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, 7 day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Novum Pharmaceuticals Research Services
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: So Ran Hong, M.D>
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328128: Investigation of the Effect of Toilet Training Given to Children
Official title: Investigation of the Effect of Toilet Training Given to Children Who Have no Problems in Their Social-emotional Development on the Process of Acquiring Toilet Habits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toilet Training
Keywords: Toilet training
Social-emotional development
Child
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the study, it was aimed to examine the factors affecting the toilet training of children aged 18-36 months who have no problems in social-emotional development and the effect of professional support on the toilet training process.

Detailed description: Toilet training studies in Turkey and analyzes of bladder, bowel control and training completion times in these studies are limited. In this study, training processes were examined separately, and the factors that were not studied frequently until today were investigated. Also the effects of the professional support provided to children who did not have problems in social-emotional development on the process were examined.

Eligibility criteria: Inclusion Criteria:

* not having received toilet training
* age of the child between 18-36 months
* normal social-emotional development
* no known chronic disease

Exclusion Criteria:

* having received toilet training
* the child's age is outside the range of 18-36 months
* abnormal social-emotional development
* presence of chronic disease

Primary outcomes:
measure: Toilet training completion age
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences, Ankara City Hospital, Children's Hospital
state: Cankaya
Study officials:
affiliation: University of Health Sciences, Ankara City Hospital, Children's Hospital
name: Aysun Kara Uzun
role: STUDY_CHAIR
affiliation: University of Health Sciences, Ankara City Hospital, Children's Hospital
name: Sevilay Yildiz Akkus
role: STUDY_CHAIR
affiliation: Gazi University
name: Bahar Cuhaci Cakir
role: STUDY_CHAIR
affiliation: University of Health Sciences, Ankara City Hospital, Children's Hospital
name: Eda Ozaydin
role: STUDY_CHAIR
References:
Clinical trial NCT00490828: Influence of Hydrocortisone on Immunologic Markers and Health Care Related Quality of Life in Patients After Cardiac Surgery
Official title: Influence of Hydrocortisone on Humoral and Cellular Immunologic Markers in High Risk Patients After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Inflammatory Response Syndrome
Posttraumatic Stress Disorder
Keywords: Cardiac surgery
systemic inflammatory response syndrome
health-related quality of life
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2007-06-25
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. A potential mechanism resulting in this effect may be its immunomodulatory action. In this prospective interventional study this hypothesis is to be proven.

Detailed description: Methods: Prospective interventional randomized double blind placebo controlled study.

Intervention: Hydrocortisone in stress doses vs. placebo

Patients: 92 high risk patients after cardiac surgery

Measurements: Cytokines, Toll-like receptors, NF kappa B, outcome data, health care related quality of life, PTSD.

Eligibility criteria: Inclusion Criteria:

* Preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min

Exclusion Criteria:

* Pregnancy
* Severe liver insufficiency
* Severe renal insufficiency
* Insulin dependent diabetes mellitus
* Steroid therapy
* Psychiatric disease

Primary outcomes:
measure: immunologic markers, health care related quality of life, PTSD
timeFrame: one and a half year
Secondary outcomes:
measure: early clinical outcome parameters (LOS in the ICU)
timeFrame: one year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Anesthesiology, University of Munich
state: Bavaria
Study officials:
affiliation: Department of Anesthesiology
name: Shananz Azad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.
citation: Hauer D, Weis F, Campolongo P, Schopp M, Beiras-Fernandez A, Strewe C, Giehl M, Toth R, Kilger E, Schelling G. Glucocorticoid-endocannabinoid interaction in cardiac surgical patients: relationship to early cognitive dysfunction and late depression. Rev Neurosci. 2012;23(5-6):681-90. doi: 10.1515/revneuro-2012-0058.
Clinical trial NCT00230828: Patient-reported Outcomes in the Treatment of Schizophrenia
Official title: Patient-reported Outcomes With Bifeprunox or Olanzapine in the Treatment of Schizophrenia. A Pharmacoeconomic Study Carried Out in Connection With the S1543003 And S1543004 Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-10-03
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patient-reported health economic outcomes for patients enrolled in S1543003 and S1543004 protocols


Eligibility criteria: Inclusion Criteria:

* Participate in S1543003 and S1543004 in the U.S. sites

Exclusion Criteria:

* Participate in S1543003 and S1543004 other than U.S. sites

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT00732628: Evaluating Outcomes in the Placement of Boomerang Percutaneous Device
Official title: Technical and Clinical Outcomes Following Placement of Boomerang Percutaneous Closure Device After Cerebral Angiography or Neurointerventional Procedures
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Medical Device
Angiography
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 200
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: patients having a neurointerventional procedure, such as a cerebral angiography

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the Boomerang percutaneous closure device following diagnostic cerebral angiography or neurointerventional procedures.

Background:

Very few publications have evaluated this relatively novel percutaneous closure device.

Detailed description: The purpose of this study is to document our experiences using the Boomerang closure device. Several different closure devices are used in the department of Radiology. A closure device is something that is placed in the artery in the leg just prior to removing the catheters from your leg at the end of the imaging or treatment procedure that is to be performed in the Department of Radiology. The devices used are all FDA approved. This study will compare the Boomerang device (a newer FDA approved device) to the other older devices currently being used. You may not have the Boomerang device used in your procedure; however, the Boomerang device is used in almost all of our patients undergoing a neuro imaging or treatment procedure. The neuroradiologist will determine which device if any is best for you based on the size of your artery, your medical condition etc. We will only collect data about you and your procedure if the Boomerang device is used.

Eligibility criteria: Inclusion Criteria:

* Any patient that has a percutaneous Boomerang closure device placed after having a neuro-intervention

Exclusion Criteria:

* Patients that do not have this medical device used post procedure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT00004328: Phase II Study of the Pathophysiology and Treatment With Enalapril and Polystyrene Sulfonate for Pseudohypoaldosteronism, Type I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pseudohypoaldosteronism
Keywords: endocrine disorders
pseudohypoaldosteronism
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 1999-10-19
Enrollment: 1
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism.

II. Determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance.

III. Investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.

Detailed description: PROTOCOL OUTLINE: Sodium and potassium intake resulting in normalization of serum electrolytes and markers of extracellular volume are determined at baseline. A trial diet is then prescribed, with adjustments made to achieve a steady state with normal serum electrolytes. Exercise tolerance and muscle function are evaluated at steady state.

Sodium and potassium are sequentially manipulated with diet, enalapril, and polystyrene sulfonate. Exercise tolerance is evaluated during each diet period.

A treatment plan to maintain electrolyte balance is developed. The patient is followed monthly for 3 to 6 months, then every 3 months for up to 3 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Pseudohypoaldosteronism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Bruce S. Keenan
role: STUDY_CHAIR
References:
Clinical trial NCT00601328: Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Calcitriol Tablets, 0.25 mg, Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondary Hyperparathyroidism
Hypocalcemia
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2008-01-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Calcitriol or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence
timeFrame: Baseline, Two period, Fourteen day washout
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Dennis Morrison, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04931628: Efficacy and Safety of Salvianolic Acid on AIS
Official title: Efficacy and Safety of Salvianolic Acid on Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Stroke, ischemic, Acute
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Wenzhou Medical University
name: Second Affiliated Hospital of Wenzhou Medical University
name: Zhejiang University
name: Ningbo No. 1 Hospital
name: Zhejiang Hospital
name: Zhejiang Provincial Tongde Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Xiaoshan People's Hospital
name: Red Cross Hospital, Hangzhou, China
First posted: 2021-06-18
Enrollment: 1
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: Stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. In my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis.

Studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. Salvia miltiorrhiza is a commonly used traditional Chinese medicine in traditional medicine in my country. Salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. It is the water-soluble active part of salvia miltiorrhiza. It can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection Cardiovascular system.

The purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.


Eligibility criteria: Inclusion Criteria:

1. Acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified Rankin Scale (mRS) score ≤1, onset within 72h;
2. CT examination to rule out cerebral hemorrhage;
3. With clear signs of nervous system positioning, the National Institutes of Health Stroke Scale (NIHSS) score ≥ 4

Exclusion Criteria:

1. Diseases with bleeding tendency;
2. Liver and kidney dysfunction;
3. Malignant tumors or those undergoing anti-tumor treatment;
4. Allergic physique, allergic to aspirin or Salvianolic Acid;
5. Heart failure, multiple system failure;
6. Pregnant or breastfeeding women

Primary outcomes:
measure: MRS score
timeFrame: 90 days
Secondary outcomes:
measure: Cerebral blood flow volume (CBV)
timeFrame: 90 days
measure: Cerebral blood flow (CBF)
timeFrame: 90 days
measure: NIHSS score
timeFrame: 90 days
measure: Adverse drug reactions (ADR)
timeFrame: 90 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Dai Haibin
state: Zhejiang
Study officials:
References:
Clinical trial NCT06456528: QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia
Official title: Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of QL0911 for the Treatment of Cancer Treatment-Induced Thrombocytopenia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Cancer Treatment-Induced Thrombocytopenia
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-13
Enrollment: 235
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of QL0911 in cancer treatment-induced thrombocytopenia. Thrombocytopenia is a low number of platelets in the blood. Sometimes, thrombocytopenia is a side effect of cancer treatment.


Eligibility criteria: Inclusion Criteria:

* Men and women, 18-75 years of age;
* Histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days;
* Participant experienced thrombocytopenia and chemotherapy delay;
* ECOG performance status 0-1;
* The estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles.

Exclusion Criteria:

* Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia;
* Participant has serious bleeding symptoms;
* History of allergy to the study drug;
* Patients with hepatitis C antibody positive and detection of HCV-RNA exceeding the upper limit, patients with hepatitis B surface antigen positive and detection of HBV-DNA exceeding the upper limit, patients with severe cirrhosis, HIV antibody positive and syphilis antibody positive;
* Pregnant or lactating women;
* Participant has received any experimental therapy within 28 days prior to screening
* Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Primary outcomes:
measure: The proportion of treatment responders.
timeFrame: Randomization up to 80 days
Secondary outcomes:
measure: Duration from the commencement of treatment to a platelet count ≥100×109/L
timeFrame: Randomization up to 30 days
measure: Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy
timeFrame: Randomization up to 150 days
measure: Number of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: Randomization up to 150 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04488328: Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis
Official title: Effect of Magnetic Therapy and Moderate Aerobic Exercise on Post Thyroidectomy Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 45
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives; This study was conducted to investigate the effect of pulsed magnetic therapy and aerobic exercise on post thyroidectomy osteoporosis.

Methods; Forty-five female patients, age ranged from 40 to 50 years old with osteoporotic changes in hip and pelvic region post thyroidectomy, were included in this study. They were selected from Endocrinology private clinics. They were assigned randomly into three groups, equal in number. Magnetic Therapy Group (group A); patients received the routine medical treatment (Bisphosphonates, Calcium, and Vitamin D) in addition to pulsed magnetic therapy on the pelvic region for 12 weeks (3 sessions/ week). Exercise group(group B); patients received the routine medical treatment in addition to moderate-intensity aerobic exercise for 12 weeks (3 sessions/week). Combined Magnetic Therapy and Exercise Therapy group (group C): patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks. Evaluation of the three groups was performed at baseline and after 12 weeks of treatment by dual energy x-ray absorptiometry (DEXA).


Eligibility criteria: Inclusion Criteria:

* All participants had undergone thyroidectomy since 6 months and had cognitive and educational level enough to understand the requirements of the study

Exclusion Criteria:

* All Patients with malignancies or receiving radiotherapy or chemotherapy, skin diseases, deep venous thrombosis or venous insufficiency, sensory impairment, renal failure, recent therapy with immunosuppressant or anticonvulsants, psychological problems or alcoholic drinkers were excluded from this study.

Primary outcomes:
measure: Osteoporosis changes
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Marwa Eid
Study officials:
affiliation: Cairo University
name: Marwa Eid
role: PRINCIPAL_INVESTIGATOR
References: