louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00536796: Percentage of Secondary Prevention Patients Treated to Their LDL-C Targets
Official title: Non-interventional Study Investigating How Effective Secondary Prevention Patients Are Treated to Their LDL-C Targets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipidemias
Atherosclerosis
Coronary Heart Disease
Carotid Stenosis
Peripheral Vascular Diseases
Diabetes Mellitus
Keywords: Hyperlipidemia
Need-to-treat
NIS
Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-09-28
Enrollment: 1096
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female secondary prevention patients with: coronary disease with event: acute coronary syndrome, status post MI, PTCA, CABG, angiographically verified), PAVK (min. IIb or S.p. revascularization), stroke/TIA, carotis-plaque (asymptomatic min. 70% or S.p. revascularization), Diabetes Mellitus (type I, II)

Brief summary: A cholesterol/lipid profile screening project of high risk patients with hyperlipidaemia (secondary prevention) who already receive cholesterol-lowering therapy. Lipid profile and rate of patients who are treated to target (which is \<100mg/dl for patients with high risk and \<70mg/dl for patients at very high risk) are screened (hospital-based specialists). The doctors therapy decisions after the screening and possible reasons for these decisions will be documented. Our aim is to evaluate dosing habits, to evaluate how many patients are treated to their LDL-C target and to underline the importance of treating patients to their cholesterol targets.


Eligibility criteria: Inclusion Criteria:

* Secondary prevention patients with hyperlipidemia and atherosclerosis (coronary heart disease, carotid stenosis, PVD, etc.) and/or diabetes who already receive cholesterol-lowering therapy

Exclusion Criteria:

* Patients who do not receive cholesterol-lowering therapy

Primary outcomes:
measure: Cholesterol levels
timeFrame: After 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rohrbach
country: Austria
facility: Research Site
state: Upper Austria
Study officials:
affiliation: Chair of the Austrian Atheroslerosis Society
name: Josef Patsch, MD
role: STUDY_CHAIR
affiliation: Co-Chair of the Austrian Atheroslerosis Society
name: Bernhard Foger, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03437096: Postoperative Pain and Venipuncture Pain
Official title: Association Between Postoperative Pain and Venipuncture Pain in Sleeve Gastrectomy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Association between venipuncture pain and postoperative pain

Detailed description: Association will be find between venipuncture pain and postoperative pain in sleeve gastrectomy patients. Also we can study with pain catastrophising scale.

Eligibility criteria: Inclusion Criteria:

* sleeve gastrectomy

Exclusion Criteria:

* psychotic illness

Primary outcomes:
measure: numeric rating scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa University
Study officials:
affiliation: Gaziosmanpasa University
name: Mustafa Süren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01640496: Vitamin D Treatment in Ulcerative Colitis
Official title: Vitamin D Treatment in Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ulcerative Colitis
Inflammatory Bowel Disease
Keywords: Ulcerative Colitis
Inflammatory Bowel disease
IBD
Vitamin D
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: North Shore University Hospital
First posted: 2012-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test blood and tissue samples of people with Ulcerative Colitis (UC) to see what effects Vitamin D3 may have on the immune system. This research is being done because it could lead to the development of new treatment for people with Inflammatory Bowel Disease (IBD).

Detailed description: The primary endpoint of the trial is the change in colonic permeability as a global assessment of vitamin D3 effects throughout the colon in patients with Ulcerative Colitis. Secondary endpoints will be changes in colonic tight junction protein expression, and their relationship to serum vitamin D level, VDR expression, inflammatory cytokines, and histologic inflammation

Eligibility criteria: Inclusion Criteria:

* Patients must be over 18 years of age
* have a diagnosis of UC as confirmed by histology.
* UC patients must have active but mild disease as confirmed by a Mayo Clinic endoscopy score from 2-4,
* not requiring medication adjustment during the trial.
* Patients must be capable of understanding the purpose, risks and expectations of study participation and willing to provide written informed consent.

Exclusion Criteria:

* Individuals on vitamin D or laxative therapy (except for purposes of endoscopy preparation),
* UC patients with fulminant colitis or active C difficile or other colonic infections,
* age\<18 year old,
* individuals with bleeding disorders will be excluded from the study.

Primary outcomes:
measure: Mucosal Permeability
timeFrame: 8 weeks
Secondary outcomes:
measure: Mucosal tight junction protein expression
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore
state: Illinois
Study officials:
affiliation: University of Chicago
name: Joel Pekow, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290596: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy
Official title: Vasopressin Versus Tranexamic Acid for Control of Blood Loss Related to Abdominal Hysterectomy: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Uterine Surgery
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 387
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Detailed description: To find the best option to reduce blood loss related to abdominal hysterectomy (AH), the present randomized double-blinded study sought to compare the effects of locally administered vasopressin (VP) and tranexamic acid (TXA) on blood loss in women submitted to AH for benign lesions.

Interventions Study interventions Patients in all groups will receive identically looking pharmaceutical preparations which differ according to the study group

1. Vasopressin group Just before beginning of AH, patients in this group will be injected with a 10-ml syringe containing 10 units of VP (5 mL bilaterally), 1 cm medial to the uterine vessels in the most distal area of the lower uterine segment not to compromise the bladder. If this site is not accessible, patients will be alternatively injected in the midline at the fundus (Okin et al., 2001). In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.
2. Tranexamic acid group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. Just before closure of peritoneum, 1.5 g of TXA mixed in 100 ml of NS will be applied topically over the raw surface (Mitra et al., 2022).
3. Control group Just before AH, patients in this group will be injected with a 10-ml syringe containing 10 ml of NS (5 mL bilaterally) as described above. In addition, and just before closure of peritoneum, 100 ml of normal saline (NS) will be applied topically over the raw surface.

Eligibility criteria: Inclusion Criteria:

- Patients will be included in the present study if they are indicated for abdominal hysterectomy for benign lesions.

Exclusion Criteria:

* history of coagulation or bleeding disorders or
* if they were under antithrombotic treatment.
* associated malignancy, renal impairment or allergy to TA.

Primary outcomes:
measure: blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03405896: The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Official title: The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ambulation Difficulty
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.

Detailed description: Subjects are reclaimed to finish several turning task under different turning angle.

The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.

Eligibility criteria: Inclusion Criteria:

* Able to walk 10 m independently without any device.

Exclusion Criteria:

* Dizzy causing by eye disorders or vestibular disease.
* Any disease which involved in gait performance.
* Can't follow the order by investigator during task.

Primary outcomes:
measure: Turning step count
timeFrame: pre-test and post-test within a week
measure: Turing time
timeFrame: pre-test and post-test within a week
measure: Stride length during turning
timeFrame: pre-test and post-test within a week
measure: Walking speed approached turning
timeFrame: pre-test and post-test within a week
measure: Turning angle
timeFrame: pre-test and post-test within a week
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang-Ming University
Study officials:
References:
Clinical trial NCT02191696: Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
Official title: Observational Study of ICD and Pacemaker Sensing in the Presence of IMED-4 Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Intersection Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present for CRM device follow-up are possible candidates for the study and shall be screened for suitability based on the inclusion and exclusion criteria.

Brief summary: The purpose is to monitor far field sensing artifacts of CRM devices in the presence of the IMED-4

Detailed description: The implanted CRM device will have shock therapy and rate sensor temporarily deactivated or placed in magnet mode during the time the IMED-4 is activated. The IMED-4 will be activated for a time not to exceed 15 minutes. During the time the IMED-4 is active, the CRM device programmer will print the voltage sensing of the implanted lead in real-time. The printout will be examined for the presence of far-field sensing artifacts.

Eligibility criteria: Inclusion Criteria:

* Subjects with an active implantable CRM device
* Subjects \> 18 years of age
* Subjects who are ambulatory not requiring assistance for ambulation
* Subjects who have been informed of the nature of the study and agree to its provisions and have provided written informed consent as approved by the IRB

Exclusion Criteria:

* Subjects who are pregnant or lactating or who have been pregnant within the past three months
* Subjects who have tattoos on the back in the electrode patch placement region
* Subjects who have had a past allergic reaction to adhesives
* Subjects who have poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Primary outcomes:
measure: IMED-4 recordings
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: North Coast Cardiology
state: California
city: Palm Springs
country: United States
facility: Desert Heart
state: California
Study officials:
References:
Clinical trial NCT00795496: Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
Official title: Bronchial Hyperreactivity in Atopic Dermatitis Patients - a 10 Year Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis
Bronchial hyperreactivity
Skin prick tests
Serum IgE
Mantoux test
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators invite all patients who participated in the FG-506-06-21 tacrolimus ointment study, and who at baseline in that study were tested for bronchial hyperreactivity.

Brief summary: The investigators will contact 64 patients with atopic dermatitis (AD) who participated in a long-term tacrolimus ointment trial in Helsinki 10 years ago, and ask them to participate in this follow-up study. The investigators will do the same tests as 10 years ago, i.e. bronchial hyperreactivity, skin prick tests, serum-IgE, Mantoux-test (2 TU), and questionnaires about asthma and allergic rhinitis symptoms. The investigators also collect data about their AD medication during the last 10 years.

The investigators hypothesis is that when the skin condition improves in patients with AD the brochial hyperreactivity improves. The investigators also want to study whether different treatments play a role in the development or resolution of bronchial hyperreactivity.

Detailed description: We will by letters and telephone contact all patients (n=64) who fulfill the inclusion criteria for this study.

The testing in the study (bronchial hyperreactivity, skin prick testing, serum IgE) is cross-sectional, but we retrospectively collect data from the last 10 years about the skin condition and medication for atopic diseases.

Eligibility criteria: Inclusion Criteria:

* Patient has participated in the FG-506-06-21 study in Helsinki
* Patient was tested for bronchial hyperreactivity in the years 1998-2000
* Patient gives signed informed consent to participate in this study

Primary outcomes:
measure: Bronchial hyperreactivity
timeFrame: 10 year follow-up
Secondary outcomes:
measure: Skin prick tests
timeFrame: 10 year follow-up
measure: Serum-IgE
timeFrame: 10-year follow-up
measure: Mantoux-test
timeFrame: 72 hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin- and Allergy Hospital, Department of Dermatology
Study officials:
affiliation: Skin- and Allergy Hospital, Dep. of Dermatology
name: Sakari Reitamo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Virtanen H, Remitz A, Malmberg P, Rytila P, Metso T, Haahtela T, Reitamo S. Topical tacrolimus in the treatment of atopic dermatitis--does it benefit the airways? A 4-year open follow-up. J Allergy Clin Immunol. 2007 Dec;120(6):1464-6. doi: 10.1016/j.jaci.2007.08.021. Epub 2007 Oct 1. No abstract available.
Clinical trial NCT00621296: Safety and Efficacy of MP-424 to Treat Chronic Hepatitis C
Official title: Phase II Study of MP-424 in Patients With (Genotype 1b) Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Chronic Hepatitis C
Protease Inhibitor
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2008-02-22
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety after administration of MP-424 to patients with chronic hepatitis C.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with genotype 1b chronic hepatitis C
* Patients naive to the concomitant medications with interferon

Exclusion Criteria:

* Patients diagnosed with decompensated cirrhosis
* Patients diagnosed with positive HBs antigen in the test

Primary outcomes:
measure: Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration
timeFrame: 24 Weeks After Completion of Drug Administration (dosing period is 24 Weeks) or drug withdrawal. The subjects were assessed at 24 weeks following the last dose of study drug.
Secondary outcomes:
Other outcomes:
Locations:
city: Kawasaki City
country: Japan
facility: Toranomon Hospital
state: Takatsu-ku
Study officials:
affiliation: Department of Hepatology, Toranomon Hospital
name: Fumitaka Suzuki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toyota J, Ozeki I, Karino Y, Asahina Y, Izumi N, Takahashi S, Kawakami Y, Chayama K, Kamiya N, Aoki K, Yamada I, Suzuki Y, Suzuki F, Kumada H. Virological response and safety of 24-week telaprevir alone in Japanese patients infected with hepatitis C virus subtype 1b. J Viral Hepat. 2013 Mar;20(3):167-73. doi: 10.1111/j.1365-2893.2012.01640.x. Epub 2012 Jul 13.
Clinical trial NCT00002296: The Safety and Effectiveness of Isoprinosine in Patients With Weakened Immune Systems and Lymph Node Disease
Official title: A Multi-Center Randomized Double-Blind Placebo-Controlled Study to Investigate the Effect of Isoprinosine in Immunodepressed Patients With Uncomplicated Generalized Lymphadenopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphatic Disease
HIV Infections
Keywords: T-Lymphocytes
Immune Tolerance
Inosine Pranobex
Killer Cells
T-Lymphocytes, Helper-Inducer
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objective of this Phase III, randomized, double-blind, placebo-controlled study in patients with immunologic deficiency is to determine the effect of Isoprinosine in producing an immuno-restorative response within the study observation period (including the 2-month period following cessation of the 28 days of treatment), measured by one or more of the following immunological parameters:

* Increase in natural killer (NK) cell activity.
* Increase in total T-cells (OKT-11).
* Increases in absolute number and percentage of T-helper cells (OKT-4).


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction and severe gastric ulcer.
* Lymphoid malignancy.
* Infectious mononucleosis caused by cytomegalovirus or Epstein-Barr virus.
* Heart disease (especially if receiving cardiac glycosides).
* Hemophilia.

Patients with the following are excluded:

* Kaposi's sarcoma or overt opportunistic infections as follows:
* Candida albicans, Pneumocystis carinii, Herpes simplex, Cryptococcus neoformans, Histoplasma capsulatum, Mycobacterium avium-intracellulare, Toxoplasma gondii, Legionella, Cryptosporidium, Isospora, and Papovavirus.
* Active evidence of infectious mononucleosis caused by Epstein-Barr virus (EBV) or cytomegalovirus (CMV) as determined by heterophil test (EBV) or cell culture (CMV).
* History of gout, uric acid urolithiasis, uric acid nephrolithiasis, renal dysfunction, and severe gastric ulcer.
* Critical illness.
* Condition requiring hospitalization.
* Women of childbearing age are excluded.
* Hemophilia.

Prior Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.
* Antiviral medicine.

Prior Treatment:

Excluded:

* Radiotherapy.

Patients who have unexplained immunodepression and are at risk of developing AIDS.

* Patients with prolonged generalized lymphadenopathy for 3 or more months (greater than 1 cm at two or more noncontiguous sites).

IV drug abuse.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Newport Pharmaceuticals International Inc
state: California
Study officials:
References:
Clinical trial NCT06251596: What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction
Official title: What is the Impact of Frozen Embryo Transfer Protocol, on Endometrial Compaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IVF
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-02-09
Enrollment: 247
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 250 IVF patients undergoing the return of frozen embryos

Brief summary: This study aims to evaluate endometrial thickness on the day of the frozen embryo transfer, compared to endometrial thickness on the last day of assessment of the endometrium before exposure to progesterone in respect to the protocols used for endometrial preparation

Detailed description: 247 FET cycles were included in the study. Records of all patients and their cryopreservation embryos were analyzed. Data collection included baseline parameters of age, BMI (kg/m2), type of infertility, parity, lifestyles, and cause of infertility, as well as treatment parameters, including number of embryos transferred, embryo quality and pregnancy outcomes.

To reflect the broad range of patients typically encountered in clinical practice, no inclusion/exclusion criteria were applied regarding baseline characteristics.

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

Pregnancy

Primary outcomes:
measure: Endometrial compaction in each group.
timeFrame: 5 years
Secondary outcomes:
measure: Implantation and pregnancy rates in each group
timeFrame: 5 years
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
state: Heifa Region
Study officials:
affiliation: Israel Hillel Yaffe medical center
name: Einat Shalom Paz, PROF
role: PRINCIPAL_INVESTIGATOR
affiliation: Israel Hillel Yaffe medical center
name: Anna Turetzky Oved, Nurse
role: STUDY_CHAIR
References: