louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00134953: Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Official title: Efficacy and Safety of Rivastigmine in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cognitive Symptoms
Keywords: Mild cognitive impairment
Alzheimer's disease
Dementia
Mild Cognitive Impairment (MCI)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-25
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with mild cognitive impairment (MCI).


Eligibility criteria: Inclusion Criteria:

* Males or females who are one year post-menopausal or without childbearing potential
* Between the ages of 50 and 85 years old
* Mild cognitive impairment confirmed by Mini Mental State Examination (MMSE) score between 23 and 27
* Cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver, according to the investigator's judgement

Exclusion Criteria:

* A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia
* A current diagnosis of epilepsy or depression, or any other diagnosis that may interfere with the patient's response to study medication
* An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: 16 week's treatment with rivastigmine on alertness, memory, attention, cognitive flexibility, orientation and language in patients with mild cognitive impairment
Secondary outcomes:
measure: Safety of 16 week's treatment with rivastigmine in patients with mild cognitive impairment
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References:
Clinical trial NCT03570853: Stress Management and Resiliency Training for Physicians
Official title: Stress Management and Resiliency Training for Physicians
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burnout, Professional
Stress
Keywords: Resiliency
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is to evaluate the effects of the SMART-3RP (Stress Management and Resiliency Training Relaxation Response Resiliency Program) on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

Detailed description: Burnout is a serious problem in healthcare, resulting in absenteeism, decreased job satisfaction, decreased empathy, anxiety, depression, increased medical errors and decreased patient satisfaction. A growing number of studies have demonstrated that programs incorporating mind-body practices increase resilience in healthcare providers and can reduce burnout and perceived stress while increasing empathy. The Benson-Henry Institute for Mind Body Medicine (BHI) has developed a clinical program for patients known as the Stress Management and Resiliency Training Relaxation Response Resiliency Program (SMART-3RP or SMART Program for short). This study is to evaluate the effect of the SMART-3RP on physician and academic faculty well-being, perceived stress, burnout, compassion, and job satisfaction.

Eligibility criteria: Inclusion Criteria:

* Physicians and academic faculty of Brigham and Women's Hospital and Newton-Wellesley Hospital

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in perceived stress: pre-program vs. post-program
timeFrame: Approximately 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Benson-Henry Institute for Mind Body Medicine
name: John Denninger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608153: Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide
Official title: Compliance of Patients With Essential Hypertension Treated With Candesartan or Candesartan/Hydrochlorothiazide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Essential Hypertension
Keywords: essential hypertension
ARB
compliance
candesartan
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 1773
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care ambulant patient

Brief summary: The CoCa study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the subject compliance as well as the efficacy and tolerability of candesartan or candesartan/HCT in subjects suffering from essential hypertension.


Eligibility criteria: Inclusion Criteria:

* essential hypertension
* under candesartan treatment

Exclusion Criteria:

-

Primary outcomes:
measure: To estimate under naturalistic conditions the compliance rate, defined as the number of subjects with regular intake of the prescribed dose of candesartan or candesartan/HCT as judged by the physician at the end of the observational period.
timeFrame: app. 3 monthly
Secondary outcomes:
measure: To assess under naturalistic conditions the subject's reason(s) for being compliant or non-compliant with the intake of the pre-scribed dose of candesartan or candesartan/HCT
timeFrame: app. 3 monthly
measure: To assess under naturalistic conditions the subject's reason(s) for withdrawal of the pre-scribed dose of candesartan or candesartan/HCT
timeFrame: app. 3 monthly
measure: To assess under naturalistic conditions whether physicians are using procedures to improve the subject's compliance regarding the intake of candesartan or candesartan/HCT and to get insight in the type and effects of these procedures
timeFrame: app. 3 monthly
Other outcomes:
Locations:
Study officials:
affiliation: University hospital Erlangen-Nurnberg
name: R. E. Schmieder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MED Dep., AstraZeneca Germany
name: Andrea Pahor, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02983253: Immunmodulation in Patients With HHT
Official title: Immunmodulation in Patients With HHT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria: Aged 18 or over, HHT,

Brief summary: Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder. Literature suggests that HHT is often associated with higher frequency of infectious diseases.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Detailed description: Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. Literature and the investigators' observation suggest that HHT is often associated with higher frequency of infectious diseases. This might be a hint for a immunocompromised situation.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Eligibility criteria: Inclusion Criteria:

* aged 18 or over, HHT

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Amounts of leucocytes in patients with HHT
timeFrame: November 2016 - December 2018
Secondary outcomes:
measure: Differences in distribution of leucocytes in patients with HHT
timeFrame: November 2016 - December 2018
Other outcomes:
measure: Functional properties of leucocytes in patients with HHT
timeFrame: November 2016 - December 2018
measure: Differences in size of leucocytes in patients with HHT
timeFrame: November 2016 - December 2018
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
Study officials:
affiliation: University Hospital, Essen
name: Urban Geisthoff, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184153: Medullary Colonic Carcinoma
Official title: Medullary Colonic Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medullary Carcinoma of Colon
Prognostic Factors
Survival Analysis
Keywords: Medullary Carcinoma of Colon
prognostic factors
survival analysis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with an anatomopathological diagnosis of colorectal adenocarcinoma of medullary type managed at the chu de Limoges between 2000 and 2020

Brief summary: Retrospective cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. Collection of relevant data for this rare entity. Subgroup analysis in search of prognostic factors. Comparison of the data from our cohort with those from the literature.

Detailed description: Colorectal cancer (CRC) is the third most common cancer in the world after breast and prostate cancer (1). It is also the second most common cause of cancer death in France (2). Most CRCs are adenocarcinomas. However, there is a distinct subtype of adenocarcinoma of relatively recent recognition, called medullary carcinomas (MC). Its recent recognition as a distinct entity (3) has made it difficult to study the epidemiologic characteristics of this cancer, with little population-based data. The largest cohort studied in the literature is from a US sample of 74 patients seen between 1973 and 2006 (4). The main objective of this French retrospective study is to highlight some common features in this group of patients with medullary colorectal cancers, thus improving our knowledge of this cancer subtype and in particular its prognosis.

Medullary colorectal cancer is a type of cancer with a prognosis of its own, probably different from the most common histological entity, colorectal adenocarcinoma.

This is a retrospective study a cohort of 10 cases of colonic adenocarcinoma of medullary type, operated between 2000 and 2020 at the University Hospital of Limoges. A collection of relevant data was realised for the subgroup analysis in search of prognostic factors for this rare entity as well as a comparison of the data from this cohort with those from the literature.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of colorectal adenocarcinoma of medullary type between 2000 and 2020

Exclusion Criteria:

* Absence of anatomopathological confirmation on the surgical specimen

Primary outcomes:
measure: Survival
timeFrame: Through study completion in April 2021
Secondary outcomes:
measure: Progression
timeFrame: Through study completion in April 2021
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Chirurgie Digestive et Endocrinienne du CHU de Limoges
Study officials:
affiliation: 0 33 5 55 05 67 30
name: Niki CHRISTOU, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00713453: Muscle Response to Enzyme Replacement Therapy in Pompe Disease
Official title: Muscle Response to Enzyme Replacement Therapy in Pompe Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pompe Disease
Keywords: Pompe disease
muscle
enzyme replacement therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-07-11
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Pompe disease, prepare or on enzyme replacement therapy

Brief summary: This study is to study the response of muscle cells from Pompe disease after enzyme replacement therapy


Eligibility criteria: Inclusion Criteria:

* patients with Pompe disease, prepare or on enzyme replacement therapy
* signed informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: all morphology changes improvement
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yin-Hsiu Chien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228953: Pharmacogenomic Testing in Major Depressive Disorder
Official title: Impact of Comprehensive Pharmacogenomic Testing on the Treatment of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Pharmacogenomic testing
Depression
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a two-arm double-blind prospective randomized controlled trial (RCT) to evaluate clinical impact of pharmacogenomic testing on the treatment of major depressive disorder. Participants will be randomly assigned to two groups: pharmacogenomic-guided therapy group (guided group) and treatment as usual group (TAU group). The primary hypothesis is the pharmacogenomic-guided treatment group will demonstrate significantly higher percent improvement in depression score compared to treatment-as-usual group.

Detailed description: To a large extent, variability in antidepressant efficacy can be explained by genetic variations that affect medication-metabolizing enzymes, drug transporters, and medication targets. Recent reviews demonstrated significant potential of pharmacogenomic testing in improving treatment of major depressive disorder. One of the major barriers towards successful implementation of pharmacogenomic testing for patients with major depressive disorder is lack of systematic evaluation of impact of this approach in routine clinical care settings. The major goal of this study is to systematically evaluate impact of comprehensive pharmacogenomic testing on the treatment of major depressive disorder in ambulatory setting.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of major depressive disorder (MDD)
2. Prescription of index antidepressant medications
3. Minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAMD-17)

Exclusion Criteria:

1. Diagnosis of bipolar disorder (any type), schizophrenia, or schizoaffective disorders
2. Active diagnosis of substance abuse or dependence
3. Current suicidal ideation
4. Previous suicidal attempts
5. A person has already had pharmacogenetic testing done.

Primary outcomes:
measure: Score on the Hamilton Rating Scale for Depression (HAMD-17)
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Score on Subject-Rated 16-item Quick Inventory of Depression Symptomatology Scales (QIDS-SR)
timeFrame: Up to 10 weeks
measure: Score on the 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Manuel Cabrera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707053: Data Collection and Analysis in Brainstem Surgeries
Official title: Data Collection and Analysis of Neuroimaging and Intraoperative Neurophysiological Monitoring (IONM) in Brainstem Surgeries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brainstem Lesion
Surgery
Intraoperative Neurophysiologic Monitoring
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is patients with lesions in or near brainstem who accept surgical resection as the optimal treatment. Estimation of 50 participants in the intra-axial brainstem surgical group, and 150 in the extra-axial brainstem surgical group. There is no other patient collective that could be used as substitute for the study population.

Brief summary: The hypothesis is that the structural documentation and analysis of the data of demographics, neuroimaging, IONM and clinical outcomes can help to further standardize the use of such equipment for detecting the integrity of the corticospinal tracts.

We want to confirm that the retrospectively data analysis of neuroimaging, IONM and clinical outcomes does help to understand these methods better in the surgical management of brainstem lesions, and therefore, improve the safety of brainstem surgery.

Detailed description: This will be a prospective data collection and retrospective data analysis study to investigate the effect of pre- and post-neuroimaging, intraoperative monitoring, and clinical outcome during the surgical management of brainstem lesions in our neurosurgical center. The data of demographics, neuroimaging, IONM and patients' outcomes will be acquired based on the medical records and follow-up visits. All data is stored in the personal file of the clinical information system for each patient. The expected duration of each subject's participation is confined to the surgery itself and the routine visits during the follow-up. The overall study duration is expected to collect all the brainstem surgery in next five years.

Eligibility criteria: Inclusion Criteria:

* Patients age 18 - 80 years' old
* With lesions in or near the brainstem
* Patients who are suitable for brainstem surgery
* Patients who accept the surgery
* Patients who signed the informed consent

Exclusion Criteria:

* Patients age \< 18 years
* Patients who are not suitable for brainstem surgery (for example patients in coma, very small lesion, pregnancy)
* Patients unlikely to attend the follow-up 12 months after surgery

Primary outcomes:
measure: Data of direct brainstem stimulation and clinical outcome
timeFrame: 09/2020-12/2021
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Oliver Bozinov, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06085053: A Clinical Trial of TQA3038 Injection in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Hepatitis b
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-16
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics.

In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).


Eligibility criteria: Inclusion Criteria:

* Male or female age 18～60 years.
* Body mass index (BMI) 19 - 26 kg/m\^2.

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation；
* History or evidence of drug or alcohol abuse；
* History of intolerance to SC injection；

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to 85 days.
measure: Number of subjects with clinically significant abnormalities
timeFrame: Up to 85 days.
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
measure: Apparent Terminal Elimination Half-life (T1/2)
timeFrame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
measure: Apparent Plasma Clearance (CL/F)
timeFrame: Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose
measure: Fraction eliminated in the urine
timeFrame: Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: