louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03386448: The Safety and Efficacy of Naltrexone and Scopolamine Utilized in the Treatment of Major Depression
Official title: The Safety and Efficacy of Naltrexone and Scopolamine Utilized in Combination in the Treatment of Major Depression: A Double Blinded, Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: The Taub Group
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded, randomized, controlled parallel design
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to determine the safety and efficacy of scopolamine utilized in conjunction with naltrexone for the treatment of major depression.

Detailed description: The study will be a double blinded, randomized controlled trial. The medications will be administered orally. The sample size will be 40 participants, 20 in the treatment group and 20 in the control group. The study period will be 4 weeks. Eligible participants will have major depression by history for at least 8 weeks, between 18-65 years old, and in generally good health other than depression. The MADRS questionaire will be utilized to determine the response to the medications.

Eligibility criteria: Inclusion Criteria:

* male or female, aged 18-65
* in good health other than major depression for 8 weeks or more
* negative pregnancy test
* able to comply with instructions
* able to provide informed consent

Exclusion Criteria:

* pregnant or lactating
* danger to self or others
* severe kidney or liver disease
* schizophrenia
* allergy to scopolamine or naltrexone
* glaucoma
* Monoamine oxidase (MAO) inhibitor use

Primary outcomes:
measure: Response to Medications as Assessed by Change in Score on Modified MDRS Scale From Baseline to End of Study Period
timeFrame: Baseline and 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: The Taub Group
state: North Carolina
Study officials:
affiliation: The Taub Group
name: Neal Taub
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05523648: Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Official title: Clinical Effects of Ganshuang Combined TDF to Treat CHB and NAFLD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Chronic Hepatitis B
Nonalcoholic Fatty Liver Disease
Lead sponsor: Sichuan Leshan Traditional Chinese Medicine Hospital
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The changes in liver function, body mass index, controlled attenuation parameters, liver stiffness and HBV-DNA at different time points in each group before and after treatment were counted to explore the clinical efficacy of Ganshuang granules combined with tenofovir in the treatment of CHB complicated with NAFLD.

Detailed description: 92 patients included in the study were randomly divided into 2 groups, 42 patients in the control group and 50 patients in the treatment group. Both groups of patients received conventional basic treatment such as liver protection. Moreover, in both groups, patients were instructed to change their dietary structure to control low-fat and low-sugar, and were instructed to perform appropriate aerobic exercise.

The control group was treated with silymarin glucosamine tablets (Jiangsu Zhongxing Pharmaceutical Co., Ltd.; National medicine permission number: H32026233; Production batch: 200304) and tenofovir (QILU Pharmaceutical Co., Ltd.; National medicine permission number: H20173185; Production batch: 1L0694DF6). The use of silymarin glucosamine tablets was 0.2g/d, 3 times/d for 24 weeks; the use of tenofovir was 300mg/d, 1 time/d for 24 weeks.

The treatment group was treated with Ganshuang granules (Baoding Tianhao Pharmaceutical Co., Ltd.; National medicine permission number: Z20027671; Production batch: 200326 ) combined with silibinin meglumine tablets and tenofovir. Libribin meglumine tablets and tenofovir were used in the same way as in the control group, and Ganshuang granules were used 3 g/time, 3 times/d, and the course of treatment was 24 weeks.

Eligibility criteria: Inclusion Criteria:

Chronic hepatitis B patients not treated with antiviral drugs； Fatty liver was diagnosed by B-ultrasound and imaging； No history of excessive drinking； Good drug compliance and regular medication； Exclusion Criteria： Non chronic hepatitis B patients； Taking other drugs； liver failure, liver cancer and other diseases； patients who refused to sign informed consent；

Primary outcomes:
measure: ALT, AST and GGT
timeFrame: 12 and 24 weeks
measure: HBV-DNA serum load < 500 IU/ml
timeFrame: 12 and 24 weeks
measure: liver stiffness
timeFrame: 12 and 24 weeks
measure: fat attenuation
timeFrame: 12 and 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leshan
country: China
facility: Sichuan Leshan traditional Chinese medicine hospital
Study officials:
affiliation: Sichuan Leshan Traditional Chinese Medicine Hospital
name: Qin Yang, MM
role: STUDY_CHAIR
References:
Clinical trial NCT02552173: The Relationship Between Operative and Radiologic Stem Version
Official title: The Relationship Between Operative and Radiologic Stem Version : Which Factors Influence Resultant Stem Version in Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty Total Hip Replacement
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between October 2015 and December 2015, 40 consecutive patients who underwent primary cementless total hip arthroplasty agreed to undergo a postoperative computed tomography scan.

Brief summary: Investigators prospectively evaluate the accuracy of intraoperative stem anteversion in 40consecutive total hip arthroplasties.

Detailed description: In all hips, investigators measure femoral stem anteversion postoperatively with three-dimensional computed tomography reconstruction of the femur, using both the distal femoral epicondyles and the posterior femoral condyles to determine the femoral diaphyseal plane. And investigators compare the surgeon's estimate of intraoperative stem version and stem version of CT scan.

Eligibility criteria: Inclusion Criteria:

* Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015

Exclusion Criteria:

* patients who could not extend the hip because of a residual flexion contracture.

who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.

Primary outcomes:
measure: Intraopertive surgeon's estimation and postoperative CT scan were taken to measure stem anteversion
timeFrame: postoperative 4days
Secondary outcomes:
measure: The correlation between stem anteversion of intraopertive surgeon's estimation and stem version postoperative CT scan
timeFrame: postoperative 4days
Other outcomes:
Locations:
city: Seongnam-Si
country: Korea, Republic of
facility: Seoul national University Bundang Hospital
state: Gyeounggi-do
Study officials:
affiliation: Director, Head of Orthopaedics, Seoul National university Bundang Hospital
name: Kyung-Hoi Koo, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06952673: Study on Multi-Modality Models of Cardiac Function in Healthy Individuals
Official title: Study on the 'Seismocardiography-Electrocardiography' Coupling Dynamics and Its Exercise-load Reactivity Model in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Volunteers Only
Keywords: Seismocardiography, ECG, Exercise Responsivity
Lead sponsor: Shanghai Ruiwei Digital Technology Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-01
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, wearable multi-modal microsensors were deployed to simultaneously capture seismocardiography (SCG) and electrocardiography (ECG) signals, delineating the exercise-load-dependent responsiveness of SCG-ECG dynamic coupling during graded-speed treadmill protocols.

Detailed description: The heart adapts to varying exercise loads primarily by augmenting heart rate and contractility to achieve matching increases in cardiac output. However, whether there exists an intrinsic triaxial regulatory mechanism governing the interdependencies among 'exercise load - heart rate response - contractility response' remains unknown. In this study, participants performed treadmill exercise at multiple speed gradients (3-8 km/h). Seismocardiography (SCG) signals were captured via an inertial measurement unit (IMU) positioned on the precordium and were used to characterize mechanical cardiac contractility. Single-lead precordial ECG provided heart rate dynamics, while CPET-derived oxygen uptake (VO₂) indexed exercise intensity. The primary objectives were to delineate SCG-ECG responsivity patterns under graded exercise intensities and quantify potential intrinsic laws linking exercise load, heart rate adaptation, and contractility modulation.

Eligibility criteria: Inclusion Criteria:

* Age 18-60 years
* Healthy individuals with no significant medical history
* Signed informed consent as an acceptance to participate to the trial

Exclusion Criteria:

* History of severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, psychiatric, or other critical systemic disorders
* Peripheral vascular diseases, musculoskeletal disorders, or other conditions limiting physical mobility
* Uncontrolled hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg)
* History of anemia
* Moderate to severe obesity (BMI ≥32.5 kg/m²)
* Pregnant or lactating women
* Any other conditions deemed ineligible for participation per investigator's discretion

Primary outcomes:
measure: Changes in SCG features (amplitude in m/s²)
timeFrame: The entire test will be completed in approximately 90 minutes.
Secondary outcomes:
measure: Changes in ECG features (R-R interval in ms)
timeFrame: The entire test will be completed in approximately 90 minutes.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00994773: Simvastatin for the Treatment of Chronic Hepatitis B
Official title: A Pilot Trial of Simvastatin Alone and Added to Tenofovir or Entecavir for the Treatment of Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: Hepatitis B
simvastatin
HBV DNA
Lead sponsor: Bader, Ted, M.D.
Sponsor class: INDIV
First posted: 2009-10-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have shown robust in vitro anti-hepatitis B activity of simvastatin alone and synergistic activity with all four FDA-approved anti-hepatitis B oral drugs tested. The investigators propose phase 1 studies in 48 chronic hepatitis B human carriers who have never been treated before. Doses of drugs will remain at or below FDA-approved dosage levels for cholesterol lowering (simvastatin) or hepatitis B (tenofovir or entecavir). Arm 1 will have simvastatin monotherapy only. Arm 2 will combine simvastatin with tenofovir. Arm 3 will combine simvastatin with entecavir. For maximum safety, the 3 arms and the dose groups in each arm will be filled consecutively and not concurrently. The definition of efficacy for simvastatin alone will be a 1 log drop of hepatitis B virus in 14 days. Efficacy for combination of drugs will require a 2 log drop of hepatitis B virus in 14 days. Numerous safety tests and stop rules are noted in the protocol.


Eligibility criteria: Inclusion Criteria:

1. Hepatitis B positive by HBV DNA within 180 days.
2. Ages 18-70.
3. Men and non-pregnant women eligible.
4. Veteran's eligibility or appropriate health insurance.

Exclusion Criteria:

1. Use of any anti-HBV medicine within 30 days.
2. Decompensated cirrhosis as evidenced by esophageal varices, ascites, or encephalopathy. (grade 1 varices without history of bleeding will be allowed, if patient meets Child's-Pugh functional classification grade A).
3. A positive urine test for marijuana or alcohol within 2 months of screening.(Allowed to repeat tests on different days, if positive first time in order to become eligible for study.
4. Severe cardiovascular disease (ejection fraction \<20%)\* or uncontrolled angina.
5. Severe pulmonary disease (FEV1 \< 1.0).
6. Chronic renal insufficiency (creatinine clearance \<50 ml/min.
7. HIV positive patients.

Primary outcomes:
measure: Reduction of HBV DNA by one log.
timeFrame: 14 days
Secondary outcomes:
measure: Alanine aminotransferase (ALT) reduction
timeFrame: 14 days
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VA Medical Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Teddy Bader, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891473: A Rehabilitative Approach in Patients With Parkinson's Disease
Official title: Impact of Mézières Rehabilitative Method in Patients With Parkinson's Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Posture
Pain
Muscle stretching
Mézières method
Camptocormia
Trunk control
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 36
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 purpose of the study is to evaluate the effectiveness of a rehabilitative approach using breathing and relaxation techniques, and specifically the elongation of the latissimus dorsi muscle according to the Mézières Method to improve balance and posture and relief pain in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Diagnosis od idiopathic Parkinson's disease (according to UK Brain Bank Criteria), Hoehn-Yahr stage ≤3 (determined during "on phase"), Mini Mental State Examination (MMSE) \> or = 27, no rehabilitation treatment carried out within 3 months prior to the study, diagnosis of Parkinson's disease by at least 5 years.

Exclusion Criteria:

* Dyskinesias
* Severe fluctuations "on-off"
* Modifications of anti-Parkinsonian drug therapy during the three months prior to the start of the study)
* Sensitivity deficit of the trunk or lower extremities (physical examination)
* Vestibular disorders or paroxysmal vertigo
* Previous thoracic or abdominal surgery
* Other neurological or orthopedic conditions involving the trunk or lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, prosthetic surgery)
* Cardiovascular comorbidities (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension)

Primary outcomes:
measure: Change of Berg Balance Scale (BBS) from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
Secondary outcomes:
measure: Change of Visual Analogue Scale (VAS) from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change of Unified Parkinson's Disease Rating Scale (UPDRS) from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change of Functional Gait Assessment (FGA) from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change of Clinical Evaluation of Posture from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change of Modified Parkinson Activity Scale (MPAS) from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
measure: Change of SF-36 Health Survey Questionnaire from baseline to 12 weeks
timeFrame: Baseline, 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Umberto I Hospital
Study officials:
affiliation: Sapienza University of Rome, Policlinico Umberto I hospital
name: Vincenzo Maria Saraceni
role: STUDY_DIRECTOR
References:
Clinical trial NCT04365673: LACE+ and MRS Score Readmission Rate Assessment
Official title: Comparing the Predictive Strength of the LACE+ Index With the MedWise Rise Score on Hospital Readmission Rates: a Non-inferiority Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hospitalism
Keywords: LACE
medication risk score
Lead sponsor: Tabula Rasa HealthCare
Sponsor class: INDUSTRY
First posted: 2020-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Information will be collected from an internal data collection excel used to provide monthly outcome intervention reports to the local Tucson hospital.

Brief summary: A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.

Detailed description: The objective of this study is evaluate a program that provides transition of care services to a local Tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. The organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. The organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. The investigators look to assess LACE+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. The outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.

Eligibility criteria: Inclusion Criteria:

* Those referred to receive transition of care services between January 2018 to December 2019 and were discharged on 10 or more medications.

Exclusion Criteria:

* 89 years or older

Primary outcomes:
measure: Readmission
timeFrame: 2018 - 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tabula Rasa HealthCare
state: Arizona
Study officials:
affiliation: Tabula Rasa HealthCare
name: Jennifer Bingham, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147273: Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting
Official title: Determination of Postprandial Glycemic Responses by Continuous Glucose Monitoring in a Real-World Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Glucose Response
Glycaemic Index
Continous Glucose Measurement
Lead sponsor: West German Center of Diabetes and Health
Sponsor class: OTHER
Collaborators: name: Bionorica SE
First posted: 2019-11-01
Enrollment: 12
Sex: MALE
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: BASIC_SCIENCE

Brief summary: Self-monitoring of blood glucose using capillary glucose testing has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood as a reference. Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Detailed description: Self-monitoring of blood glucose using capillary glucose testing (C) has a number of shortcomings compared to continuous glucose monitoring (CGM). We aimed to compare these two methods and used blood glucose measurements in venous blood (IV) as a reference. Postprandial blood glucose levels were measured after 50 g oral glucose load and after the consumption of a portion of different foods containing 50 g of carbohydrates. We also evaluated the associations between postprandial glucose responses and the clinical characteristics of the participants at the beginning of the study. Incremental area under the curve (AUCi) of postprandial blood glucose was calculated for 1 h (AUCi 0-60) and 2 h (AUCi 0-120). Despite considerable inter-individual variability of postprandial glycemic responses, CGM evaluated postprandial glycemic excursions which had comparable results compared to standard blood glucose measurements under real-life conditions.

Eligibility criteria: Inclusion Criteria:

* 18-80 years old

Exclusion Criteria:

* acute diseases, severe illness with in-patient treatment during the last 3 months, weight change \>2 kg/week during the last month, smoking secession during the last 3 months, drugs for active weight reduction, chronic medication

Primary outcomes:
measure: Postprandial glucose response
timeFrame: 1 and 2 hours after food consumption
Secondary outcomes:
measure: incremental AUC (AUCi) of postprandial glucose excursions
timeFrame: 1 and 2 hours after food consumption
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: West-German Center of Diabetes and Health
Study officials:
References:
Clinical trial NCT03906773: Advance Care Planning GuideTailored for Primary Care Patients
Official title: Validation of a Novel EHR Patient Portal Advance Care Planning Delivery System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advance Care Planning
Chronic Disease
Communication Research
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 419
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators seek to test participant intervention in a pragmatic primary care environment to the patient populations described above.

Brief summary: this project seeks to: validate results of ACP framework pilot study in a larger randomized controlled trial (rates and quality of ACP documentation) prior to using participatory design to develop an Electronic Health Record (EHR)-tethered patient portal delivered ACP communication guide, tailored for use in busy primary care settings, incorporating patients, caregivers, and primary care providers


Eligibility criteria: Inclusion Criteria:

* must have an activated patient portal account over 50 years of age scheduled for a well visit appointment or chronic visit follow up English speaking

Exclusion Criteria:

* under 50
* inactive patient portal account

Primary outcomes:
measure: Presence of Advance Care Planning (ACP) documentation as noted in description
timeFrame: 4 weeks post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: