louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06596876: A Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Official title: A Randomized, Controlled, Double-blind, Double-dummy, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HRG2010 in Parkinson's Disease With Motor Fluctuations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 450
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a multicenter, randomized, double-blind, double-dummy, active-controlled, Phase III clinical study. The aim of this trial is to evaluated the efficacy and assessed the safety of HRG2010 compared with a sustained-release cabridopa-levodopa formulation in Parkinson's Disease With Motor Fluctuations.


Eligibility criteria: Inclusion Criteria:

1. Male or female who are at age 40\~80 years with PD, consistent with the International Parkinson and Movement Disorder Society Clinical Diagnostic Criteria and who are being treated with stable regimens of DDCI+LD but experiencing motor fluctuations.
2. Mini Mental State Examination (MMSE) ≥ 24 at Screening Visit.
3. Hoehn and Yahr Stage I-IV when "on" at Screening Visit.
4. At Screening, the participant has predictable "Off" periods.
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Diagnosed with atypical or secondary parkinsonism.
2. History of narrow angle glaucoma、peptic ulcer disease or upper gastrointestinal hemorrhage.
3. Had prior functional neurosurgical treatment for PD or if such procedure(s) are planned or anticipated during the study period.
4. Nonresponsive to LD therapy.
5. In the opinion of the clinical investigator, Subjects who should not participate in the study.
6. Subjects who are allergic to the investigational drug to be used in this study.
7. Pregnant or breastfeeding.
8. Participants who have previously participated in an HRG2010 study.

Primary outcomes:
measure: Change from baseline in "Off" time at Week 21
timeFrame: Last three days collected at the end of treatment period, at Week 21
Secondary outcomes:
measure: Change from baseline in "On" Time Without Troublesome Dyskinesia at Week 21
timeFrame: Last three days collected at the end of treatment period, at Week 21
measure: Change from baseline in the Movement Disorders Society Version of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) at Week 21
timeFrame: Week 21
measure: Change from baseline in the 39-item Parkinson's Disease Questionnaire (PDQ-39) at Week 21
timeFrame: Week 21
measure: Adverse events
timeFrame: Week 23
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05022576: Robotic-arm Assisted Ga-68 PSMA PET/CT Guided Transgluteal Prostate Biopsy
Official title: Trans Gluteal Automated Robotic Arm Assisted Ga-68 Prostate-specific Membrane Antigen Position Emission Tomography/ Computed Tomography Guided Percutaneous Prostate Biopsies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Positron Emission Tomography Computed Tomography
Glu-NH-CO-NH-Lys-(Ahx)-((68)Ga(HBED-CC))
Biopsy
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2021-08-26
Enrollment: 78
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Gallium-68 prostate-specific-membrane-antigen (Ga-68 PSMA) PET/CT is being used in Prostate cancer imaging. In the present study, we aimed to evaluate the efficacy and safety of robotic arm-assisted Ga-68 PSMA PET/CT-guided transgluteal prostatic biopsy.

Seventy-eight participants with a clinical suspicion of PCa were recruited from January 2019 to September 2020. All the patients underwent whole-body Ga-68 PSMA PET/CT. The patients with PSMA-avid lesion in the prostate underwent robotic arm-assisted PET-guided transgluteal biopsies. The degree of pain during the procedure, procedure-related complications and histopathology were evaluated.


Eligibility criteria: Inclusion Criteria:

i. Clinically or biochemically suspected cases of Ca Prostate. ii. Patients with PSMA avid lesion in the prostate iii. Patients, who were ready to give written informed consent for biopsy iv. In good general condition (Karnofsky performance status, KPS, of more than 70).

Exclusion Criteria:

i. No focal PSMA expressing lesion in the prostate ii. Patients who refused to give written informed consent iii. Abnormal coagulation profile iv. Acute prostatitis, any severe acute or chronic medical condition

Primary outcomes:
measure: The diagnostic yield of the procedure
timeFrame: three months
measure: Safety of the procedure
timeFrame: Seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Department of Nuclear Medicine, PGIMER
state: Chandīgarh
Study officials:
References:
citation: Kumar R, Singh SK, Mittal BR, Vadi SK, Kakkar N, Singh H, Krishnaraju VS, Kumar S, Bhattacharya A. Safety and Diagnostic Yield of 68Ga Prostate-specific Membrane Antigen PET/CT-guided Robotic-assisted Transgluteal Prostatic Biopsy. Radiology. 2022 May;303(2):392-398. doi: 10.1148/radiol.204066. Epub 2022 Feb 22.
Clinical trial NCT02527876: Exercise, Activity and Smoking in Young Adults
Official title: Exercise to Promote Quit Attempts in Young Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Exercise, Delayed Control
Keywords: Exercise
Smoking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program.

Detailed description: The purpose of this study is to evaluate how physical activity levels change in young adults when they start a specific exercise program. Physical activity levels will be monitored daily via a FitBit Flex. Outcome measures include number of minutes of activity per day and distance traveled per day.

Eligibility criteria: Inclusion Criteria:

* 18-40 years old,
* stable physical/mental health,
* current smoker
* currently minimally active,
* ambulatory,
* interested in increasing their physical activity,
* willingness to attend weekly exercise intervention sessions at a SNAP Fitness location within 10 miles of the University of Minnesota campus,
* the ability to comply with the study protocol and provide informed consent

Exclusion Criteria:

* Contraindications to increasing physical activity including, but not limited to,
* abnormal electrocardiogram or V02 test results,
* high blood pressure (defined as systolic blood pressure over 165 or diastolic blood pressure over 100),
* heart attack, acute (2 days) cardiac event or stroke in preceding six months,
* unstable angina,
* uncontrolled dysrhythmias causing hemodynamic compromise,
* symptomatic severe aortic stenosis,
* uncontrolled symptomatic heart failure,
* acute pulmonary embolism or pulmonary infarction,
* acute myocarditis or
* pericarditis,
* dissecting aneurism,
* acute systemic infection and
* unstable pulmonary or cardiovascular conditions.

Primary outcomes:
measure: Number of Participants With Increase in Physical Activity as assessed by FitBit
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DCRU
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alicia Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06193876: The Effect of Aromatherapy Before Clinical Practice on Stress, Anxiety and Depression in Midwifery Students
Official title: The Effect of Petitgrain and Ylang-ylang Oil Applied Before Clinical Practice on Stress, Anxiety and Depression in Midwifery Students.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aromatherapy
Stress
Depression
Lead sponsor: Balikesir University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned as a randomized controlled study to determine the effects of petitgrain and ylang ylang oil applied before clinical practice on stress, anxiety and depression in midwifery students.


Eligibility criteria: Inclusion Criteria:

* Being a midwifery student

Exclusion Criteria:

* Having an asthma or any other respiration disease
* Trouble of smelling
* Allergies to petitgrain or ylang-ylang essential oil

Primary outcomes:
measure: depression level
timeFrame: 1 day
measure: stress level
timeFrame: 1 day
measure: anxiety level
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Korkut Ata University Hospital
Study officials:
References:
Clinical trial NCT05347576: A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 31
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-393(2) in Healthy Volunteers Under Fed Conditions

Detailed description: A randomized, open-label, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-393(2) in healthy volunteers under fed conditions

Eligibility criteria: Inclusion Criteria:

1. Healthy adult volunteers aged 19 ≤ \~ \< 55-year-old.
2. Weight ≥55kg (man) or 45kg (woman), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2.
3. Those who have no congenital diseases or chronic diseases within 3 years and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory(hematology, blood chemistry, serology, urology) and 12-lead ECG results at screening.

Exclusion Criteria:

1. Those who have clinically significant disease or medical history of heart failure, Hepatopathy, Type 1 Diabetes, Diabetic ketoacidosis, Edema, Renal dysfunction, galactose intolerance, glucose-galactose malabsorption. And Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) during clinical trial.
2. Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of investigational drug.
3. Those who are pregnant or breastfeeding.
4. Those who are deemed inappropriate to participate in clinical trial by investigators.

Primary outcomes:
measure: AUCt
timeFrame: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
measure: Cmax
timeFrame: Pre-dose(0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 (h ) hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Min Gul Kim, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01109576: Workshops for Veterans With Vision and Hearing Loss
Official title: Pilot Study: Self Management Groups for Veterans With Dual Sensory Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deafness
Blindness
Keywords: deafness-blindness
pilot study
self management education
dual sensory loss
rehabilitation
peer support groups
age related
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Atlanta VA Medical Center
First posted: 2010-04-23
Enrollment: 13
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study of workshops to help Veterans with both vision and hearing loss live a happier, fuller and less stressful life. The results will be used to guide the development of a large scale clinical trial.

Detailed description: This pilot study will enrolled 13 Veterans with Dual Sensory Loss (DSL), age 65 to over 89. The project headquarters in the Portland Oregon Veterans Affairs Medical Center will be tasked with the development of the workshops and writing of a Curriculum and Procedures Manual. The Atlanta VAMC research collaborators enrolled the 13 Veterans. Staff turnover reduced time available for enrollment and data collection. We therefore eliminated the original comparison group design and this study had only one experimental intervention arm and no control intervention or other arm. Veterans were chronologically enrolled who responded to recruitment letters and who passed telephone and onsite screening. The intervention consisted of six weekly two hour workshops providing information, skills training and exercises about self-managing DSL effects on daily life. Preliminary effectiveness data was collected and analyzed, and a large scale clinical trial will be proposed as a followup to explore the efficacy of this management approach. This study data tracked pre and post intervention within subject changes.

Eligibility criteria: Inclusion Criteria:

* Veteran;
* Vision loss \> 20/70 better eye;
* Hearing loss \> 40 decibels better ear;
* Cognition Within Normal Limits (WNL);
* No behavioral flag or psychiatric diagnosis;
* Documented psychosocial restrictions secondary to vision and hearing loss

Exclusion Criteria:

* Vision and/or hearing can be corrected by surgical or pharmacological treatment;
* Requires use of sign language interpreter

Primary outcomes:
measure: Change in Profile of Mood States Total Score.
timeFrame: Change in Profile of Mood States Score from Baseline to 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: Veterans Health Administration (VHA)
name: Mitchel Turbin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06816576: The Effect of Emotional Freedom Techniques Application on Patients With Cancer Phobia
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Emotion Regulation
Death Anxiety
Keywords: Death Anxiety
postoperative
Emotional Freedom Technique
cancer phobia
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pre-testpost- test control group experimental model.
Primary purpose: OTHER

Brief summary: The aim is to examine the effect of Emotional Freedom Technique on death anxiety in patients with postoperative cancer phobia.

The hypotheses of the study are as follows:

H0: Emotional Freedom Technique has no effect on postoperative death anxiety in patients with cancer phobia.

H1: Emotional Freedom Technique has a positive effect on postoperative death anxiety in patients with cancer phobia.

Detailed description: Intervention Group

After coming to the clinic after surgery and after their condition was stable, the patients were given the patient introduction form, subjective discomfort unit, cancer anxiety scale and death anxiety scale as a pre-test. The researchers provided Emotional Freedom Technique (EFT) training to the patients and asked them to apply Emotional Freedom Technique. After an average of 3 days, the subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a post-test.

Control Group

After coming to the clinic after surgery and after their condition was stable, the patient introduction form, subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a pre-test. No intervention was made to the control group patients outside the clinical protocol. After an average of 3 days, the subjective discomfort unit, cancer anxiety scale and death anxiety scale were applied as a post-test.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age,
* Having had oncological surgery,
* Having no visual or auditory problems,
* Having no psychiatric problems.

Exclusion Criteria:

* Not accepting to participate in the study or wanting to leave,
* Being under 18 years of age,
* Having been previously diagnosed with cancer.

Primary outcomes:
measure: death anxiety
timeFrame: After coming to the clinic after surgery and their condition becoming stable, the death anxiety scale was applied to the patients as a pre-test. Three days later, the death anxiety scale was applied as a post-test.
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Şerafettin OKUTAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456976: Efficacy of Selegiline in Negative Symptoms of Schizophrenia
Official title: Efficacy of Selegiline Augmentation of Antipsychotic Medication to Treat Negative Symptoms in Inpatients With Chronic Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Keywords: Seligiline
Negative symptoms
Schizopherenia
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antipsychotic drugs are effective in treating the positive symptoms of schizophrenia; however their efficacy in treating negative symptoms is limited. This study wants to evaluate efficacy of selegiline augmentation of antipsychotic medication to treat negative symptoms in inpatients with chronic schizophrenia. With randomized clinical trial two groups of patients will select to receive selegiline or placebo.

Primary end point is decreasing in negative symptoms in case group. Inclusion criteria : 1- Patients with moderate to severe negative symptoms 2- Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month. 3- No other psychotropic drugs during past month. Exclusion criteria: 1- Severe major depressive disorder, substance abuse, severe positive symptoms of schizophrenia, Treatment of MDD with antidepressant drugs during past month.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to severe negative symptoms
* Patients with at least one year antipsychotic drug therapy, at the current dose \>= 1 month.
* No other psychotropic drugs during past month

Exclusion Criteria:

* Severe major depressive disorder
* Substance abuse
* Severe positive symptoms of schizophrenia
* Treatment of MDD with antidepressant drugs during past month.

Primary outcomes:
measure: decreasing in negative symptoms in case group
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Razi university hospital
state: East Azarbaijan
Study officials:
affiliation: Tabriz University of Medical Sciences
name: Fatemeh Ranjbar Kouchaksaraei, Assistant Professor
role: STUDY_CHAIR
References:
Clinical trial NCT05642676: Welcoming by Design Pilot: Reducing Structural Stigma by Changing Clinic Systems and Architectural Design
Official title: Welcoming by Design Pilot: Reducing Structural Stigma by Changing Clinic Systems and Architectural Design to Make HIV Clinics More Friendly, Private, and Patient-Centric
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test the feasibility and acceptability of implementing clinic system changes and physical structures in Uganda to improve aesthetics, welcome, and privacy to reduce HIV stigma, improve retention-in-care, and improve the patient experience.

To evaluate pilot/implementation outcomes, the outcomes of fidelity, feasibility, and acceptability will be assessed prior to intervention. After the changes are done to two HIV interventions clinics, the outcome surveys will assess if the changes were disruptive or impeded the workings of the clinics.


Eligibility criteria: Inclusion Criteria:

* Adults 18 and older
* Enrolled in the HIV clinics where we are working
* Able to independently consent for interview, survey, or focus group.

Exclusion Criteria:

* Unable to provide consent
* Does not speak English or Luganda (local language around Kampala and Entebbe)

Primary outcomes:
measure: Acceptability survey
timeFrame: Baseline
measure: Feasibility
timeFrame: baseline
measure: Fidelity to the Intervention
timeFrame: 6-months post intervention
measure: Outcomes survey
timeFrame: 6-months post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References: