louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03675750: Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism
Official title: Effects of Hyperprolactinemia Induced by Antipsychotic Drugs on Bone Metabolism
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Keywords: antipsychotic drugs
hyperprolactinemia
bone metabolism
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese outpatients or inpatients with schizophrenia

Brief summary: The study is aimed to assess the severities of hyperprolactinemia caused by antipsychotic drugs and the effects of the duration of hyperprolactinemia on bone metabolism in schizophrenia patients.

Detailed description: Hyperprolactinemia is a common adverse effect of antipsychotic drugs. Studies have shown that hyperprolactinemia may affect bone metabolism through direct and indirect effects and increase the risk of osteoporosis and fracture.The investigators assess the duration, the severity of hyperprolactinemia and its effects on bone metabolism in schizophrenics taking antipsychotic drugs through analyzing the correlation between prolactin levels and biochemical markers of bone metabolism and the correlation between the duration of hyperprolactinemia and abnormal bone metabolism. Meanwhile, the investigators aims to obtain the boundary value of prolactin levels in patients with abnormal bone metabolism.

Eligibility criteria: Inclusion Criteria:

* 1. Diagnosis of the disease meets the ICD-10 diagnostic criteria for schizophrenia 2. Subjects Intend to use atypical antipsychotics 3. Age between 18 and 50 years of age

Exclusion Criteria:

* 1. Pregnant and breast feeding women 2. Abnormal lipid metabolism 3. The level of serum alanine aminotransferase or aspartate aminotransferase is two times higher than the upper limit of the normal 4. Patients with diabetes or impaired fasting glucose 5. The level of prolactin is higher than normal 6. Patients taking drugs that affect bone metabolism (e.g. selective serotonin reuptake inhibitors antidepressants, antiepileptic drugs) 7. The level of creatinine is 1.2 times higher than the upper limit of the normal value

Primary outcomes:
measure: Bone turnover biochemical markers
timeFrame: baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks
Secondary outcomes:
measure: serum prolactin
timeFrame: baseline ,4 weeks ,8 weeks，12 weeks and 26 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: LiHua Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180050: Budesonide Treatment for Lymphocytic Colitis
Official title: Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Microscopic Colitis
Keywords: lymphocytic colitis
microscopic colitis
budesonide
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Dr. Falk Pharma GmbH
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Detailed description: The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis

Eligibility criteria: Inclusion Criteria:

* lymphocytic colitis
* diarrhea
* effective contraception
* written informed consent

Exclusion Criteria:

* other forms if IBD
* celiac disease
* infectious colitis
* history of colonic surgery
* use of budesonide, 5-ASA, steroids within th previous 4 weeks
* pregnancy, lactation

Primary outcomes:
measure: Proportion of patients in clinical remission after 6 weeks
Secondary outcomes:
measure: safety
measure: quality of life
measure: histological improvement
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Medical Department I, Technical University Hospital
Study officials:
affiliation: Medical Department I, Technical University Hospital, Dresden, Germany
name: Stephan Miehlke, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04262050: Combined tDCS and TMS on Subjective Tinnitus and Combined Depression
Official title: The Effect of Combination Transcranial Direct Current Stimulation and Transcranial Magnetic Stimulation on Subjective Tinnitus and Combined Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Depression
Keywords: Tinnitus, tDCS, TMS
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators combined transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) to increase the effective response of a single session of neuromodulation in subjective tinnitus.

Detailed description: To treat motor and psychiatric disorders, transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) are world-widely in use in clinics. The investigators combined these two types of neuromodulation techniques to increase the effective response of a single session of neuromodulation in subjective tinnitus. Experimental groups with 80 tinnitus subjects consisted of four different treatment groups which are tDCS, tDCS with sham TMS, tDCS-TMS and TMS group. Subjects were given 1.5milliampere (mA) tDCS on the bi-frontal area and TMS stimulated contralateral single side of the temporoparietal cortex with 200 pulses at 1herz (Hz) stimulation.

Eligibility criteria: Inclusion Criteria:

* Research volunteers who agreed to participate in the clinical trial were gathered from the tinnitus clinic of the Department of Otorhinolaryngology Head-and-Neck Surgery, Seoul National University Bundang Hospital

Exclusion Criteria:

* psychoactive drug user
* implanted material
* pacemaker user

Primary outcomes:
measure: Tinnitus handicap inventory
timeFrame: the same 1 day after treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00620750: Extended-release Naltrexone for Alcohol Dependence in Primary Care
Official title: Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alcohol Dependence
Keywords: Alcohol dependence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Alkermes, Inc.
First posted: 2008-02-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.


Eligibility criteria: Inclusion Criteria:

* Current alcohol dependence
* Age 18 or older
* English or Spanish-speaking
* Without untreated severe mental illness
* Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal
* Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly
* Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence
* If female of child-bearing potential, must be using adequate contraception
* Able to understand study procedures

Exclusion Criteria:

* Currently opioid dependent or requiring ongoing treatment with opioids for any indication

Primary outcomes:
measure: Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Marc N Gourevitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2.
citation: Lee JD, Grossman E, Huben L, Manseau M, McNeely J, Rotrosen J, Stevens D, Gourevitch MN. Extended-release naltrexone plus medical management alcohol treatment in primary care: findings at 15 months. J Subst Abuse Treat. 2012 Dec;43(4):458-62. doi: 10.1016/j.jsat.2012.08.012. Epub 2012 Sep 15.
Clinical trial NCT03712150: Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability
Official title: Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young volunteers

Brief summary: This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.

Detailed description: The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes

Eligibility criteria: Inclusion Criteria:

* Age 19-40 years
* Informed consent

Exclusion Criteria:

* History of epilepsy
* Presence of cardiac pacemaker
* previous brain surgery
* previous swallowing problems
* current use of medication which acts on the central nervous system
* presence of implanted metal intracranially

Primary outcomes:
measure: Brain corticobulbar excitability
timeFrame: Immediately after single conditioning the brain
Secondary outcomes:
measure: Tongue pressure measurement-
timeFrame: Immediate after single conditioning the brain
measure: Electrophysiological responses of swallowing -
timeFrame: Immediate after single conditioning the brain
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine
state: Bucheonshi
city: Bucheon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine
state: Kyounggido
Study officials:
affiliation: The Catholic University of Korea
name: Sun Im, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05857150: Exercise Response in Humans With Obesity
Official title: Exercise Response in Humans With Obesity
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obese
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women ages 20-45 years with Body Mass Index less than 25 or greater than 30 kg/m2.

Brief summary: This study is being done to understand how chronic inflammation affects muscle function and responses to exercise.


Eligibility criteria: Inclusion Criteria:

* Obese men and women ≥ 20 and ≤ 45 years of age.

Exclusion Criteria:

* Diabetes or fasting plasma glucose \>126 mg/dL
* Anemia (female subjects hemoglobin of \<11 g/dl and male subjects hemoglobin \<12 g/dl)
* Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment)
* Renal failure (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease defined as aspartate aminotransferase (AST)\>144 IU/L or alanine transaminase (ALT) \>165 IU/L)
* Oral warfarin group medications or history of blood clotting disorders.
* Smoking
* Pregnancy or breastfeeding
* Alcohol consumption greater than 2 glasses/day or other substance abuse
* Untreated or uncontrolled hypothyroidism
* Debilitating chronic disease (at the discretion of the investigators)

Primary outcomes:
measure: Change in muscle protein synthesis
timeFrame: Baseline, post-exercise approximately 8 hours
Secondary outcomes:
measure: Change in mRNA expression of exercise responsive genes
timeFrame: Baseline, post-exercise approximately 8 hours
measure: Change in expression and activation (phosphorylation) of signaling proteins
timeFrame: Baseline, post-exercise approximately 8 hours
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ian Lanza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05755750: Intratendinous Genipin Injection in Horses With Tendon Injuries
Official title: Clinical and Ultrasonographic Evaluation of Intratendinous Genipin Injection in Horses With Superficial Digital Flexor Tendon Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Superficial Digital Flexor Tendonitis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our study is the first to use genipin, a naturally occurring collagen cross-linking agent, as a therapeutic agent to treat superficial digital flexor tendon (SDFT) injuries in horses. The promising approach of intratendinous genipin injection and tendon mechanical enhancement could be a viable alternative to current therapies for SDFT injuries.

Detailed description: Tendon injuries are a career limiting or ending condition in horses. Genipin (GP), an exogenous collagen crosslinker, provides ex-vivo tendon mechanical augmentation and excellent biosafety. The main objective of this study is to investigate treatment success of GP-induced collagen crosslinking in a clinical application in horses with superficial digital flexor tendon (SDFT) injuries. Horses with an AAEP (American Association of American Practitioners) lameness score \> 0 and sonographically confirmed tendinopathy are treated with intratendinous GP injection (IGI) and controlled exercise. Minimal follow-up was set at 12 months. Outcome factors are lameness (AAEP lameness score), soundness, assessment of return to previous use, and re-injury. Additionally, adverse effects are recorded.

Eligibility criteria: Inclusion Criteria:

* clinical and sonographic evidence of a tendon injury

Exclusion Criteria:

* in the final analysis, only superficial digital flexor tendon injuries were included
* if follow-up was less than 12 m due to euthanasia, death or other reasons, horses were excluded from the study

Primary outcomes:
measure: Recovery from tendon injury
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Equine surgery, Vetsuisse-Faculty, University of Zurich
state: ZH
Study officials:
affiliation: Professor, Head of Department
name: Fürst Anton, Prof Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02079350: Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Liver Transplantation
Lead sponsor: Turkiye Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2014-03-05
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients undergoing living donor liver transplantation

Brief summary: Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.


Eligibility criteria: Inclusion Criteria:

-Normal kidney function

Exclusion Criteria:

* anormal kidney function
* cadaveric transplantation
* emergency operation
* patients less than 18 years old

Primary outcomes:
measure: renal dysfunction
timeFrame: 1 month
Secondary outcomes:
measure: mortality
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic
Study officials:
References:
Clinical trial NCT00713050: Speech and Language Therapy After Stroke
Official title: Neurophysiological Measurement in Aphasia Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ischemic Stroke
Keywords: stroke
aphasia
imitation
mirror neuron
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
name: Shirley Ryan AbilityLab
First posted: 2008-07-11
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.

Detailed description: Detailed information will follow in the next progress report.

Eligibility criteria: Inclusion Criteria:

1. Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)
2. Aphasia
3. Visual attention and language comprehension sufficient to perform imitation fMRI tasks
4. Right handed (prior to stroke)

Exclusion Criteria:

Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.

Primary outcomes:
measure: Changes in scores on Western Aphasia Battery
timeFrame: Four months
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Solodkin/Small Brain Circuits Laboratory
state: California
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: University of Chicago
name: Steven Small, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.
Clinical trial NCT02843750: Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Official title: A Pilot Study of Inspiratory Muscle Training for Patients Undergoing Esophageal Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer of Esophagus
Cancer of the Esophagus
Esophageal Cancer
Esophagus Cancer
Esophagus Neoplasm
Neoplasms, Esophageal
Keywords: Rehabilitation
Inspiratory Muscle Training
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To obtain definitive evidence for the effectiveness of a short preoperative inspiratory muscle training (IMT) protocol on the morbidity and recovery from an esophageal surgical resection.


Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with esophageal cancer and scheduled for esophageal resection at the Mayo Clinic Rochester with gastric conduit reconstruction -Cognitively capable to understand and perform a preoperative program
* Able to follow the intervention program for at least 2 weeks before surgery (surgery is usually scheduled 4 to 12 weeks after radiation)
* Willing to sign the informed consent form

Exclusion Criteria:

* Unable to communicate in the English language
* Participating in a conflicting trial concerning esophageal resection

Primary outcomes:
measure: Postoperative Pneumonia
timeFrame: 3 months
Secondary outcomes:
measure: Postoperative Pulmonary Complications
timeFrame: 3 months
Other outcomes:
measure: Length of Hospital Stay
timeFrame: 3 months
measure: Quality of Life
timeFrame: Baseline to 3 months
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo
role: PRINCIPAL_INVESTIGATOR
References: