louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05118503: Personalized Patient and Caregiver Education After Stroke
Official title: Personalized Patient and Caregiver Education After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Stroke, Ischemic
Stroke
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized pilot trial to evaluate the impact of a customizable stroke education app (vs standard of care discharge education) on patient satisfaction and education retention. The impact of the intervention will be assessed 7, 30, and 90 days post-discharge.


Eligibility criteria: Inclusion Criteria:

* Admitted for ischemic stroke
* At least 18 years old
* Patient or caregiver has access to a smart phone, tablet or computer
* Being discharged to either home or acute rehab

Exclusion Criteria:

* Patient or caregivers unable or unwilling to access the customized app with a smartphone, tablet, or computer
* Being discharged to a skilled nursing facility
* moderate-to-severe aphasia at the time of enrollment (as per NIHSS scoring) if patient is being enrolled without a caregiver

Primary outcomes:
measure: Patient satisfaction survey
timeFrame: Day 90
measure: Stroke etiology awareness
timeFrame: Day 90
measure: Stroke Patient Education Retention (SPER) survey
timeFrame: Day 90
measure: EuroQOL-VAS
timeFrame: Day 90
Secondary outcomes:
measure: Stroke etiology awareness
timeFrame: Day 7
measure: Stroke etiology awareness
timeFrame: Day 30
measure: Stroke risk factor awareness. 7 days
timeFrame: Day 7
measure: Stroke risk factor awareness, 30 days
timeFrame: Day 30
measure: Stroke risk factor awareness, 90 days
timeFrame: Day 90
measure: Stroke prevention med awareness, 7 days
timeFrame: Day 7
measure: Stroke prevention med awareness, 30 days
timeFrame: Day 30
measure: Stroke prevention med awareness, 90 days
timeFrame: Day 90
measure: Patient satisfaction, 7 days
timeFrame: Day 7
measure: Patient satisfaction, 30 days
timeFrame: Day 30
measure: SPER, 7 days
timeFrame: Day 7
measure: SPER, 30 days
timeFrame: Day 30
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Christopher Favilla, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00035503: Multicenter Trial For Patients With Acute Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2002-05-06
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 see if etiprednol dicloacetate is safe and effective for the treatment of acute Crohn's disease.


Eligibility criteria: * Must have active confirmed Crohn's disease with CDAI \> 220 and \< 400.
* Otherwise healthy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stuart Weisman
state: California
city: Denver
country: United States
facility: University of Colorado Medical Center
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Hollywood
country: United States
facility: Mark Lamet
state: Florida
city: Hollywood
country: United States
facility: Wayne Schonfeld
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Chicago
country: United States
facility: University of Chicago Hospital Medical Center
state: Illinois
city: Louisville
country: United States
facility: Gerald Dryden
state: Kentucky
city: Albany
country: United States
facility: Richard MacDermott
state: New York
city: Toronto
country: Canada
facility: Hillary Steinhart
state: Ontario
city: Montreal
country: Canada
facility: Gary Wild
state: Quebec
Study officials:
References:
Clinical trial NCT00815503: Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy
Official title: Postoperative Analgesia With Local Infiltration After Periacetabular Osteotomy For The Treatment Of Dysplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periacetabular Osteotomy
Pain
Keywords: Anesthetics
Local infiltration
Periacetabular osteotomy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 70
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: Pain treatment after periacetabular osteotomy is traditionally based on systemic opioids wich have side effects. The purpose of this study is to evaluate the analgetic effect of wound infiltration with local anaesthesia after periacetabular osteotomy.


Eligibility criteria: Inclusion Criteria:

* Periacetabular osteotomy due to traditional dysplasia or retroverted acetabulum
* Informed consent

Exclusion Criteria:

* Intolerance of local anaesthesia
* Habitual use of opioids

Primary outcomes:
measure: Consumption of rescue analgetics
timeFrame: Assesment of opioid rescue analgetics every 24 hours for 14 days postoperatively
Secondary outcomes:
measure: Pain
timeFrame: Assessment of pain four times every day for five days postoperatively
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
citation: Bech RD, Ovesen O, Lindholm P, Overgaard S. Local anesthetic wound infiltration for pain management after periacetabular osteotomy. A randomized, placebo-controlled, double-blind clinical trial with 53 patients. Acta Orthop. 2014 Apr;85(2):141-6. doi: 10.3109/17453674.2014.899840.
Clinical trial NCT06552403: Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China
Official title: Effect of a Modified 5:2 Intermittent Fasting Diet on Population With Overweight or Obesity in China: A Self-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: Zhejiang Provincial Tongde Hospital
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Detailed description: There are fewer studies on the influence of dietary interventions on the Chinese populations with obesity, and the degree of obesity, body fat distribution, dietary pattern and structure, and metabolic status of populations with obesity are different between the Chinese and European populations. The effects of a 5:2 IF dietary intervention on the Chinese population with overweight or obesity are unclear. Therefore, this study aimed to investigate the effects of the modified 5:2 IF dietary intervention on the Chinese population with overweight or obesity based on a self-controlled clinical trial.

Eligibility criteria: Inclusion Criteria:

1. participants aged 18 to 60 years
2. participants with a body mass index (BMI) ≥ 24 kg/m2
3. participants engaged in light physical labor and their weight was relatively stable.

Exclusion Criteria:

1. participants taking any medication with an effect on body weight in the three months prior to enrollment;
2. participants with liver or kidney dysfunction (liver enzymes ≥ 2 times normal; blood creatinine \> the upper limit of normal);
3. participants with a history of cardiovascular disease (e.g., coronary heart disease, stroke);
4. participants with malignant tumors;
5. women during pregnancy or breastfeeding;
6. participants deemed unsuitable by the investigator to participate in this trial.

Primary outcomes:
measure: body measurements
timeFrame: 24 weeks after intervention
measure: glycolipid metabolism indicators
timeFrame: 24 weeks after intervention
measure: adipokines
timeFrame: 24 weeks after intervention
measure: inflammatory factors before the modified 5:2 IF diet intervention and after 24 weeks of intervention
timeFrame: 24 weeks after intervention
Secondary outcomes:
measure: Change in metabolic components
timeFrame: 24 weeks after intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Xiaoli Wang
Study officials:
affiliation: Zhejiang Provincial Tongde Hospital
name: Xiaoli Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04338503: Mechanically Optimizing Cardiac Preload in Heart Failure Patients
Official title: Mechanically Optimizing Cardiac Preload Using Partial Inferior Vena Cava Occlusion to Reduce Pulmonary Pressures in Heart Failure Patients in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: pulmonary edema, preload
Lead sponsor: Cardioflow Technologies, LLC
Sponsor class: INDUSTRY
Collaborators: name: Saint Thomas Health
First posted: 2020-04-08
Enrollment: 10
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: Decompensated congestive heart failure patients referred for right heart catheterization.

Brief summary: The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.


Eligibility criteria: Inclusion Criteria:

1. Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
2. New York Heart Association (NYHA) II or III.
3. Subjects must be last least 18 years of age.
4. A left ventricular ejection fraction \>= 20%.
5. Pulmonary artery occlusion pressure, or pulmonary wedge pressure \>20 mmHg.

Exclusion Criteria:

1. Subjects without sinus rhythm.
2. Evidence of right heart failure.
3. Patients with primary pulmonary hypertension
4. Pulmonary wedge pressure \<15mmHg.
5. Significant lung disease, such as prior diagnosis of COPD.
6. Resting or dynamic outflow tract gradient
7. Patients with left bundle branch block

Primary outcomes:
measure: Change in pulmonary arterial pressures
timeFrame: During partial balloon occlusion
Secondary outcomes:
measure: Change in cardiac output
timeFrame: During partial balloon occlusion
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Saint Thomas Heart
state: Tennessee
Study officials:
References:
Clinical trial NCT01771003: Remote Ischemia Pre-Conditioning in Patients Undergoing Partial Nephrectomy
Official title: The Effect of Remote Ischemic Preconditioning in Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: Partial nephrectomy
renal cell carcinoma
Renal Function
Remote ischemia preconditioning
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 21
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: Partial Nephrectomy has become the standard treatment in patients with tumours \<7cm (T1). Even though this is a nephron sparing surgery, there is still potential for acute kidney injury, due to ischemia during the surgery. Remote Ischemia Preconditioning may prevent acute kidney injury and in turn chronic kidney disease. Remote Ischemia pre-conditioning involves applying a blood pressure cuff and inflating and deflating several times immediately prior to surgery.


Eligibility criteria: Inclusion Criteria:

* Patient must be a candidate for laparoscopic partial nephrectomy
* ECOG Performance status of 0-1

Exclusion Criteria:

* No diagnosis of any current cutaneous, vascular or neural disease in the right upper arm.
* If the patient received isoflurane for any indication during the operation

Primary outcomes:
measure: Change in Kidney Function before and after surgery
timeFrame: up to 2 weeks prior to surgery and up to 24 hrs post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Michael Jewett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473603: Effect of Free Fatty Acids (FFA) on Androgen Precursors in Women
Official title: Effect of Free Fatty Acids on Androgen Precursors in Vivo in Healthy Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperandrogenism
Glucocorticoid Metabolism
Keywords: androgens
fatty acids
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether free fatty acids modify the androgen levels in healthy young women.

Detailed description: Free fatty acids (FFA) are known to play an important role by inducing insulin resistance and metabolic disturbances in obesity and type 2 diabetes. In addition, FFAs seems to have a stimulatory effect on adrenal androgen precursors in men. However, the effect of FFAs on androgen precursors and androgens in women is yet unknown.

Therefore the effect of increased FFAs on adrenal androgens and androgen precursors should be investigated in a randomized controlled cross-over trial.

Eligibility criteria: Inclusion Criteria:

* healthy men and women

Exclusion Criteria:

* diabetes mellitus or impaired glucose tolerance
* clinical signs of hyperandrogenism
* polycystic ovary
* hormonal therapy
* BMI \> 30 kg/m2
* dysmenorrhoea

Primary outcomes:
measure: change of DHEA
timeFrame: 1 day
measure: change of DHEAS
timeFrame: 1 day
measure: change of testosterone
timeFrame: 1 day
measure: change of androstenedione
timeFrame: 1 day
Secondary outcomes:
measure: urinary androgen excretion
timeFrame: 1 day
measure: urinary cortisol excretion
timeFrame: 1 day
measure: urinary cortisone excretion
timeFrame: 1 day
measure: changes in metabolic parameters (e.g. FGF-21)
timeFrame: 1 day
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, Campus Benjamin Franklin
Study officials:
name: Knut Mai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05993403: The Cultural Sensitivity Education Program
Official title: The Effect of The Cultural Sensitivity Education Program Applied to Nurses on The Level of Intercultural Sensitivity and Compassion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intercultural Sensitivity
Keywords: Compassion
Intercultural sensivity
Nursing
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted with a randomized controlled experimental design to determine the effect of intercultural sensitivity training applied to nurses on intercultural sensitivity and compassion level.
Primary purpose: OTHER

Brief summary: The research was carried out with a randomized controlled experimental design in order to determine the effect of intercultural sensitivity training applied to nurses on intercultural sensitivity and compassion level. Nurses working in a private hospital were included in the sample of the study. A total of 66 nurses, 32 of whom were in the intervention and control groups, were included in the study. "Personal Information Form", "Intercultural Sensitivity Scale" and "Compassion Scale" were used to collect data. "Intercultural Sensitivity Training" consisting of four sessions was given to the intervention group.

Detailed description: Within the scope of the research, an intercultural sensitivity training program for nurses was created. The training program was implemented and an evaluation was made after the implementation.

Eligibility criteria: Inclusion Criteria:

* Being a nurse working under the Nursing Services Directorate
* Volunteering to participate in research

Exclusion Criteria:

* Having a disease that prevents participation in the study

Primary outcomes:
measure: Intercultural Sensitivity Level (Intercultural Sensitivity Scale)
timeFrame: before the implementation
measure: Intercultural Sensitivity Level (Intercultural Sensitivity Scale)
timeFrame: four weeks after the start of application
measure: Intercultural Sensitivity Level (Intercultural Sensitivity Scale)
timeFrame: three months after the finish of implementation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT04081103: NEXAGON for the Treatment of Corneal Persistent Epithelial Defects Following Severe Ocular Injuries
Official title: A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) in Subjects With Corneal Persistent Epithelial Defects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Corneal Persistent Epithelial Defect
Lead sponsor: Amber Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.


Eligibility criteria: Inclusion Criteria:

1. Male and female of any age.
2. The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
3. The PED is non-responsive to current standard of care for at least 14 days from injury.
4. The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
5. Providing written informed consent and ability to comply with the visit and dosing schedule.

Exclusion Criteria:

1. Have active ocular infection.
2. Subjects with corneal perforation or impending corneal perforation.
3. Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
4. Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
5. Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
6. Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.

Primary outcomes:
measure: The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
timeFrame: Up to 56 days.
measure: Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
timeFrame: Up to 30 days after last application of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
Study officials:
affiliation: Amber Ophthalmics
name: Maria Feldman
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002403: Safety and Effectiveness of Zintevir (AR177) Given to HIV-Infected Patients
Official title: A Phase I/II Multiple Dose Study to Evaluate the Safety, Pharmacokinetic Profile and Virologic/Immunologic Activity of Zintevir (AR177) in HIV-1 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1
Dose-Response Relationship, Drug
HIV Integrase Inhibitors
HIV Integrase
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give zintevir (AR177) to asymptomatic (no symptoms) HIV-infected patients.

Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. HIV uses the protein integrase to infect a cell. Integrase inhibitors block integrase and may stop replication of HIV.

Detailed description: Zintevir belongs to a new class of anti-HIV drugs, the integrase inhibitors. The HIV-1 virus uses the protein integrase to incorporate its genetic material into the infected host cell. Integrase inhibitors block integrase and may stop replication of the HIV-1 virus.

In this open-label, Phase I/II study, 3 groups of HIV-positive patients (12 patients total) receive escalating doses of intravenous zintevir for 14 consecutive days.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive, but do not have any symptoms of HIV infection.
* Have a CD4 count greater than 200 cells/mm3.
* Have a viral load (level of HIV in the body) greater than 4,000 copies/ml.
* Are at least 18 years old.

Exclusion Criteria

You will not be eligible for this study if you:

* Tend to have abnormal bleeding or other blood problems.
* Have an active AIDS-defining illness.
* Have a history of serious disease or illness.
* Abuse alcohol or drugs.
* Have received certain medications.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell AIDS Clinical Trials Unit
state: New York
Study officials:
References: