louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01996644: A Double Blind Clinical Trial of DCS for Food Anxiety
Official title: A Double Blind Clinical Trial of DCS for Food Anxiety for Patients With Anorexia and Bulimia Nervosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anorexia and Bulimia Nervosa
Keywords: Anorexia, Bulimia, Anxiety, Exposure
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-11-27
Enrollment: 47
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pilot study investigating if cycloserine (DCS; a learning enhancement medication) augments exposure therapy for food anxiety in patients with anorexia and bulimia nervosa. The investigators expect that (a) exposure therapy will reduce anxiety (b) anxiety will be reduced more in the DCS relative to placebo condition (c) participants in the DCS condition will have a greater increase in Body Mass Index.

Detailed description: This study investigated if DCS vs placebo augmented food exposure in individuals with eating disorders.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Anorexia Nervosa, Bulimia Nervosa, Eating Disorder Not Otherwise Specified

Exclusion Criteria:

* Pregnant or planning on becoming pregnant
* Psychotic or Manic

Primary outcomes:
measure: Anxiety as Measured by the Subjective Units of Distress (Ranging From 1 to 100).
timeFrame: Twice a week for two weeks
measure: Body Mass Index
timeFrame: twice a week for two weeks and at initial assessment
Secondary outcomes:
Other outcomes:
measure: Fear of Food Measure
timeFrame: Twice during 2 weeks
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
citation: Levinson CA, Rodebaugh TL, Fewell L, Kass AE, Riley EN, Stark L, McCallum K, Lenze EJ. D-Cycloserine facilitation of exposure therapy improves weight regain in patients with anorexia nervosa: a pilot randomized controlled trial. J Clin Psychiatry. 2015 Jun;76(6):e787-93. doi: 10.4088/JCP.14m09299.
Clinical trial NCT04230044: A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy
Official title: A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Partial-onset Seizures
Keywords: E2007
Fycompa
Perampanel
Partial onset seizures
Epilepsy
Seizures
Post marketing surveillance
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 117
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with epilepsy aged 12 years or older.

Brief summary: The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.


Eligibility criteria: Inclusion Criteria:

1. Male and female participants aged 12 years and older
2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
4. Participants who had provided written informed consent

Exclusion Criteria:

1. Participants not fit to receive Fycompa® as per the latest prescribing information.
2. Participants who were participating in a clinical trial, at the time of the study.
3. Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
4. Participants who according to the Investigators would not be able to comply with study procedures.

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
timeFrame: Up to 54 Weeks
Secondary outcomes:
measure: Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)
timeFrame: Baseline, Week 52
measure: Response Rate
timeFrame: Baseline, Week 12, Week 24 and Week 52
measure: Change From Baseline in Clinical Global Impression of Change (CGIC) Scores
timeFrame: Baseline, Week 12, Week 24 and Week 52
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171444: Comparison of Two Treatment Strategies in Hypertensive Patients
Official title: A 8-week Comparison, in a General Practice Setting, Between Two Treatment Strategies With Valsartan and Valsartan/HCTZ Aiming at Normalizing de Novo Hypertensive Patients Who Are Not Adequately Controlled With Their Monotherapy or Biotherapy Treatment or Experiencing Unacceptable Side-effects, According to Their Baseline Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension,
valsartan+hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 4445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to determine whether a specific training of General Practitioners (Family Physicians) regarding the new official guidelines for the treatment of hypertension results in a higher control of high Blood pressure in their patient population.


Eligibility criteria: Inclusion Criteria:

* • Male or female patients \>18 years of age

  * Hypertension defined by MSDBP ≥ 90 and /or MSSBP ≥ 140 mmHg for untreated patients, patients on diet and exercise, patients on current anti-hypertensive monotherapy or bitherapy treatment who remain uncontrolled or patients experiencing unacceptable side-effects,

Exclusion Criteria:

* • Severe hypertension, secondary hypertension, type 1 diabetes mellitus

  * History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
  * Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Blood pressure less than 140/90 mmHg in non-diabetic patients, or less than 130/80 mmHg in patients with diabetes or kidney disease, after 8 weeks
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 8 weeks
measure: Change from baseline diastolic blood pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or reduction in diastolic blood pressure greater than 10 mmHg
measure: Systolic blood pressure less than 140 mmHg or reduction in diastolic blood pressure greater than 15 mmHg
Other outcomes:
Locations:
Study officials:
affiliation: Novatis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01419444: Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Official title: Telemedicine Versus Traditional Treatment of Muscle Tension Dysphonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Muscle Tension Dysphonia
Keywords: Voice
Muscle Tension Dysphonia
Hyperfunction
Treatment
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine whether treatment of voice disorders can be provided just as effectively using telemedicine as it can using on-site, traditional therapy. An exercise protocol for improving airflow with voicing has been demonstrated to be effective in a prior UAMS investigation (Protocol 107454). These exercises are used as part of the normal clinic routine at UAMS working with individuals with voice problems. The three exercises used are: gargling with and without voicing; cup bubble blowing with and without voicing; and, stretch and flow exercises, which involves the use of a piece of tissue to provide visual biofeedback on the ability to use proper airflow with voicing. The purpose of the exercises is to increase airflow and breathiness in the voice and reduce muscle tension. In addition, patients will be taught to use a "confidential voice" or gentle voice during speaking.

The investigators voice patients come from all over the state and many cannot return for regular treatment. Developing a way to provide treatment to them closer to home could greatly improve quality of care and quality of life. Twenty participants will participate for 12 sessions each. All participants will be evaluated at UAMS before and after treatment as part of standard care and will, upon consent, be randomized to receive treatment via telemedicine at an AHEC site or at UAMS Medical Center. Homework will be provided along with log sheets. Results of airflow measures using an airflow-recording device (Viasys, KAY/PENTAX) pre- and post treatment will determine whether telemedicine results are equal to results of traditional, on-site treatment. The investigators hypothesize that results from treatment using telemedicine will be equivalent to results for onsite, traditional treatment.


Eligibility criteria: Inclusion Criteria:

* Primary or Secondary Muscle Tension Dysphonia

Exclusion Criteria:

* Head and Neck Cancer
* Spasmodic Dysphonia
* Tremor
* Respiratory Compromise
* Dysphagia

Primary outcomes:
measure: Mean Expiratory Airflow During Comfortable Phonation
timeFrame: 6 weeks
measure: Voicing Efficiency
timeFrame: 6 weeks
Secondary outcomes:
measure: Voice Handicap Index Questionnaire
timeFrame: 6 weeks
measure: Consensus Auditory Perceptual Evaluation of Voice
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: UAMS Medical Center Voice and Swallowing Clinic
state: Arkansas
Study officials:
References:
Clinical trial NCT00369044: Prednisone for Decompensated Congestive Heart Failure
Official title: Chronic Administration of Prednisone in Management of Patients With Decompensated Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Congestive
Keywords: decompensated heart failure
prednisone
diuretics
diuresis
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2006-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We designed this, randomized, double-blind, placebo-controlled trial to determine the clinical efficacy of chronic administration of prednisone on renal function and clinical status when added to standard care.

Detailed description: Studies showed that glucocorticoids could specifically dilate renal vessel, increase in GFR, and regulate synthesis and release of atrial natriuretic peptide (ANP), upregulate ANP receptors on vascular endothelial cells, leading to significant diuresis and natriuresis. Adding glucocorticoids to standard care may potentiate the diuretic and natriuretic effects of diuretics and improve renal function, thus improve the clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* Hospitalized with primary diagnosis of CHF
* Patients with normal cortical function
* LVEF \<40%
* Significant fluid overload, defined as ≥ 2 of the following

  * Enlarged liver or ascites
  * Peripheral or sacral edema ( ≥ 2+)
  * Jugular venous distention ≥ 10 cm
  * Pulmonary rales, pleural effusion on chest x-ray or orthopnea

Exclusion Criteria:

* Severe stenotic valvular disease
* Serum creatinine \> 4 mg/dl
* Patient refusal
* Any signs of infection or any condition that would contraindicate an glucocorticoids use
* Poor controlled hypertension
* Poor controlled diabetes mellitus
* Active myocarditis
* Malignancy or other terminal illness

Primary outcomes:
measure: Change from baseline in serum creatinine level, Patient and physician-assessed symptom scales at day 1, day 3, the end of week 1 and week 2
Secondary outcomes:
measure: Daily urine volume, changes in body weight, serum electrolyte levels at the end of week 1, week 2, respectively, and overall safety profile
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Kunshen Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu C, Chen H, Zhou C, Ji Z, Liu G, Gao Y, Tian L, Yao L, Zheng Y, Zhao Q, Liu K. Potent potentiating diuretic effects of prednisone in congestive heart failure. J Cardiovasc Pharmacol. 2006 Oct;48(4):173-6. doi: 10.1097/01.fjc.0000245242.57088.5b.
Clinical trial NCT04131244: In Vitro Follicle Activation in Patient With Premature Ovarian Failure Under 36 Years Old
Official title: In Vitro Follicle Activation of Dormant Follicles in Patient With Premature Ovarian Failure Under 36 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activation of Primordial Follicles
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: St. Marianna University School of Medicine
name: Stanford University
First posted: 2019-10-18
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial that the investigators aim to validate In-vitro Activation (IVA) treatment protocol, which was previously defined by Kazuhiro Kawamura (MD) and Aaron Hsueh (PhD), in Turkish patient with Premature Ovarian Insufficiency (POI) under age 36.

Detailed description: The objectives of the study is as following;

* Validation of the previously defined In-Vitro Activation Protocol approach in Turkish patients under 36 years old with Premature Ovarian Insufficiency (POI).
* Giving an opportunity to young POI patient in Turkey for having genetically own baby.
* Primary outcome measure would be live birth.
* For activation of primordial follicles, phosphatase and tensin homolog (PTEN) inhibitor and protein kinase B (AKT) stimulator will be used.

Eligibility criteria: Inclusion Criteria:

* Patient with POI
* Short amenorrhea period (1 - 2 years)

Exclusion Criteria:

* Having been treated with chemotherapy and/or radiotherapy;
* Having been diagnosed with advanced stage of endometriosis (endometriomas)
* Having been diagnosed with the chronic diseases such as diabetes, cardiac failure, kidney insufficiency, morbid obesity etc..
* Presence of chromosomal abnormality (Turner, Fragile-X etc.)
* Previous multiple laparotomies
* Menopause \>10 years
* Accompanied azoospermia

Primary outcomes:
measure: Live birth
timeFrame: 2 years
Secondary outcomes:
measure: Follicle growth rate
timeFrame: 1 year
measure: M-II oocyte rate
timeFrame: 1 year
measure: Day 2-3 good quality embryo rate
timeFrame: 1 year
measure: Clinical pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University School of Medicine, Department of Ob/Gyn
Study officials:
References:
Clinical trial NCT02501044: Oxygen Desaturation During Hemodialysis
Official title: Oxygen Desaturation During Hemodialysis: Clinical Correlates and Association With Adverse Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Disease
Hypoxia
Lead sponsor: Renal Research Institute
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 5500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal Research Institute hemodialysis patients

Brief summary: Hemodialysis patients may experience drops in blood oxygen saturation during the hemodialysis treatment, which may lead to hypoxia in the tissues.

The investigators hypothesize that:

1. The cumulative number, severity, or other characteristics of such deoxygenation episodes may be a predictor of adverse outcomes in hemodialysis patients.
2. There may be demographic, anthropometric, clinical, treatment prescription, lab analytical, and other parameters that correlate with the number and severity of deoxygenation episodes and, therefore, may be used for risk stratification. Further, some of these parameters may be modifiable.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patient

Exclusion Criteria:

-

Primary outcomes:
measure: Cumulative number of deoxygenation episodes
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Renal Research Institute
state: New York
Study officials:
affiliation: Renal Research Institute
name: Peter Kotanko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05424744: Telemedicine Management of Hypertension
Official title: Telemedicine Management of Hypertension: A Pre-Implementation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension management
blood pressure monitoring
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: enroll up to 10 patients/clinic
Primary purpose: SUPPORTIVE_CARE

Brief summary: Explore barriers, facilitators, acceptability, feasibility, and fidelity of the telemedicine management of hypertension intervention

Detailed description: The purpose of the current study is to conduct pre-implementation work to understand the determinants of the telemedicine management of hypertension intervention implementation, feasibility of the intervention and its tailoring, and explore potential inequitable implementation factors in African American patients to enhance the intervention's usability to inform future hybrid trial design.

Eligibility criteria: Inclusion Criteria Patients:

* \> 18 years of age
* diagnosis of Hypertension (HTN)
* systolic Blood Pressure \> 140mmHg on last two clinic visits
* stable anti-HTN medication in the preceding six weeks
* possess smart phone
* must speak and read English

Exclusion Criteria Patients:

* conditions that diminish the ability to conduct home-based self-assessments of Blood Pressure
* chronic conditions that add complexity in HTN management
* recent acute health changes that increases likelihood of Blood Pressure instability
* terminal illness

Inclusion Criteria Stakeholders:

* identify stakeholders using Mendelow's stakeholder matrix, which helps recognize stakeholders according to their interest and power in using the intervention in their clinic - Stakeholders are from clinic and community health workers

Primary outcomes:
measure: Acceptability of Intervention (AIM)
timeFrame: Month 3
measure: Appropriateness of Intervention (IAM)
timeFrame: Month 3
measure: Feasibility of Intervention (FIM)
timeFrame: Month 3
measure: Fidelity of Intervention/implementation
timeFrame: Month 3
measure: Cost Estimates
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Yashashwi Pokharel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658744: Video Training to Reduce Insulin Administration Errors
Official title: Effect Of Reducing Insulin Implementation Errors In Education Compared To Routine Approach In Type 2 Diabetes Patients Using Insulin: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insulin Injection Pad
Injection Site
Insulin Implementation Errors
Educational Problems
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Efficiency of training with video to reduce injection errors in patients using insulin

Detailed description: The aim of this study is to examine the effects of using insulin administration video and insulin administration brochure as teaching materials in insulin administration training given to type 2 diabetes patients on correcting insulin administration errors. This randomized controlled experimental study was carried out with 94 people who applied to the diabetes outpatient clinic of Istanbul Medeniyet University Goztepe Training and Research Hospital between December 2019 and January 2021. Using a computer-based randomization method, 52 and 42 people were assigned to the groups that received training with video and brochures, respectively. In the first interview, patients' insulin administration characteristics were evaluated, and the training was repeated using the video or brochure, after which the training material corresponding to the group according to the randomization list was given. Insulin administration characteristics of the patients were re-evaluated one week and three months later. Patient information form developed by the researcher based on the literature was used to collect the data. Data were analysed using descriptive statistics, independent sample t-test and Mann Whitney U test. The error rates in the interviews were analysed with the Cochrane Q test, and the relationship between independent categorical variables was examined with the Chi-square test.

Eligibility criteria: Inclusion Criteria:

* mobile phone can download video
* video watching skills

Exclusion Criteria:

* illiterate patient
* new to insulin therapy
* who can't watch video on mobile phone

Primary outcomes:
measure: Behavior change
timeFrame: 3 months later
Secondary outcomes:
Other outcomes:
Locations:
city: Kadıköy
country: Turkey
facility: Goztepe Prof Dr Suleyman Yalcın City Hospital
state: İstanbul
Study officials:
References: