louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00937755: The Study of Atypical Antipsychotics-induced Metabolic Disturbances
Official title: The Study of Atypical Antipsychotics-induced Metabolic Disturbances
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Antipsychotics
Keywords: schizophrenia
antipsychotics
glucose homeostasis
metabolic disturbance
Lead sponsor: Taipei Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2009-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: psychiatric outpatient clinic and inpatient units

Brief summary: Schizophrenia is one of the most severe mental illnesses. The antipsychotic drugs, introduced in early 1950s, have revolutionized the treatment of schizophrenia. About 2 to 4 times as many patients relapse when treated with a placebo as do those treated with antipsychotic drugs. For these medications to be maximally beneficial, they must have an acceptable side effect profile and be taken as prescribed. One untoward effect of many antipsychotic drugs is weight gain. The extent of weight gain apparently varies by drug, which may be because of drugs'differing degrees of action on serotonergic, dopaminergic, histaminergic, and other neurotransmitter systems. Obesity is a threat to health and longevity. Weight gain may also cause patients taking antipsychotic medication to discontinue their medication, which may predispose them to relapse.

The pattern of weight gain and metabolic disturbance may vary between the different antipsychotic agents. The underlying mechanism and treatment of these adverse metabolic effects remain unclear. This study will recruit 60 schizophrenic patients during. The patients received monotherapy with atypical antipsychotics (olanzapine, quetiapine, or risperidone). The assessment of metabolic profile will be monitored at baseline, week 2, week 4, and week 8. The measurements include anthropometrical parameters, body composition, glucose level, insulin level, lipid profile, and leptin level. Intra-venous glucose tolerance test will be used to assess the insulin secretion and insulin sensitivity.

This proposal broadly aims to discover the underlying mechanism of antipsychotics induced metabolic disturbance and develop efficient treatment to correct it.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of schizophrenia
* age 18-60 years

Exclusion Criteria:

* received any SGAs prior to this study
* medical conditions that may confound glucoregulatory assessment
* pregnancy

Primary outcomes:
measure: glucose homeostasis
timeFrame: 8 weeks
Secondary outcomes:
measure: lipid homeostasis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University-Municipal Wan-Fang Hospital
Study officials:
References:
Clinical trial NCT00159055: Adoptive Immunotherapy for CMV Disease
Official title: Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: CMV Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment strategy of patients:

Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.

Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.

Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.

Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.

Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.


Eligibility criteria: Inclusion Criteria:

* For Patient:
* Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
* Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
* Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
* Patients with HLA phenotype for which a relevant peptide for CMV exists.
* For Donor:
* Consenting sibling \>18 years old.
* HLA phenotype for which a relevant peptide for CMV exists.

Exclusion Criteria:

* For Patient:
* Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
* For Donor:
* Consenting sibling \>18 years old.
* HLA phenotype for which a relevant peptide for CMV exists.
* Donor with an infectious disease (e.g. HIV-1; HBV, etc.)

Primary outcomes:
measure: Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.
Secondary outcomes:
measure: Evaluate toxicity of the procedure.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826755: Melatonin Effects on Cardiovascular Disease Mechanisms in the Menopause Transition: A Randomized Clinical Trial
Official title: Melatonin Effects on Cardiovascular Disease Mechanisms in the Menopause Transition: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perimenopause
Hypertension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-02-14
Enrollment: 70
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this research is to study the effects of 12 weeks of melatonin supplementation compared to placebo in women who are in the menopause transition (perimenopause) and have high blood pressure.


Eligibility criteria: Inclusion Criteria

* Age 40-55 years old
* Female individuals with intact uterus and at least one ovary
* Currently in the menopause transition

  o Defined as self-reported bleeding patterns encompassing the early and late perimenopause phases, in accordance with the Stages of Reproductive Aging Workshop (STRAW) Criteria:6 a difference of ≥7 days in the length of consecutive menstrual cycles which recurs within 10 cycles from the first occurrence (early menopause), or 2 to 12 months of amenorrhea (late perimenopause)
* Hypertension

  o Defined as a prior diagnosis of hypertension, use of antihypertensive agents, or office SBP/DBP ≥130/80 mmHg
* On stable medical regimen (≥ 2 months) if taking other medications

Exclusion Criteria

* Prescription sleeping medications or melatonin supplementation
* Pregnant or lactating
* Night shift work
* Current or recent (within the past 2 months) use of hormonal contraceptives
* Current or recent (within the past 2 months) use of hormone replacement therapy
* On prescription aspirin
* Severe lactose intolerance
* History of substance use disorder
* History of suicidal ideation
* History of clinically diagnosed anemia or low hemoglobin levels (\<11.6 g/dL) within the past 12 months
* Active cancer
* Severe daytime sleepiness (score \>15 at the Epworth Sleepiness Scale)
* Current or recent (within the past 2 months) participation in other research studies at the discretion of study investigators
* Inability to provide written consent and/or to speak and read English
* Any other medical, geographic, or social factor making study participation impractical

Primary outcomes:
measure: Change in Nocturnal Systolic Blood Pressure (SBP)
timeFrame: Measured at baseline and at the end of the 12-week intervention
measure: Change in Nocturnal Diastolic Blood Pressure (DBP)
timeFrame: Measured at baseline and at the end of the 12-week intervention.
Secondary outcomes:
measure: Change in Oxidative Stress Markers
timeFrame: Measured at baseline and at the end of the 12-week intervention.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Naima Covassin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04009655: The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Official title: The Effects of Music Therapy on Near-infrared Spectroscopy and Electroencephalogram in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Music
Near-infrared Spectroscopy
Electroencephalogram
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 45
Sex: ALL
Minimum age (years): 224
Maximum age (years): 258
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music has been consistently shown magic power in brain plasticity. Several study proved music can influence electronic activity of preterm infants' brain, while none study covered region oxygen metabolic. The investigators aim to discover the effects of music therapy on near-infrared spectroscopy and electroencephalogram in premature infants.

Detailed description: Previous studies of music therapy have made some achievements for adult Parkinson's disease, schizophrenia, depression, anxiety, post-traumatic stress and pediatric autism spectrum disorders. For newborns, studies mainly focused on the effects of basic vital signs, feeding and pain score decreasing. So far, no studies evaluating the effect of music therapy on brain oxygen metabolic and electronic activity.

Eligibility criteria: Inclusion Criteria:

* Postmenstrual age of 32-36+6 weeks.
* Appropriate weight for gestational age.
* To have signed an informed consent to participate in the study.
* Have reached clinical stability.

Exclusion Criteria:

* Have nervous system diseases or obvious nervous system symptoms.
* Severe congenital diseases.
* The maintenance of sedative or analgesic drugs.
* Support with mechanical ventilation.

Primary outcomes:
measure: change of brain oxygen saturation
timeFrame: from the start of the intervention to the end of the 3rd day
Secondary outcomes:
measure: Burdjalov Scores of amplitude integrated electroencephalogram
timeFrame: from the start of the intervention to the end of the 3rd day
measure: change of heart rates
timeFrame: from the start of the intervention to the end of the 3rd day
measure: change of respiratory rates
timeFrame: from the start of the intervention to the end of the 3rd day
measure: change of pluse oxygen saturation
timeFrame: from the start of the intervention to the end of the 3rd day
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: lai s wang, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03151655: Changing Opioid Users' Negative Attitudes Toward Medication Assisted Treatment
Official title: Changing Opioid Users' Negative Attitudes Toward Medication Assisted Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this treatment development project, the investigators propose to develop and assess the feasibility and acceptability of a narrative-based video intervention and accompanying workbook (entitled MATTeRS: Medication Assisted Treatments: Telling Real Stories) designed to be used by people in inpatient opioid detoxification. Using the Health Belief Model as a framework, videos will provide information about the uses and outcomes of Medication Assisted Treatments (MATs) compared to other or no post-detoxification treatment through the use of narratives from real people's lives.


Eligibility criteria: Inclusion Criteria:

1. Currently undergoing inpatient opioid detoxification;
2. Qualify for use of one or more MATs;
3. Have health insurance;
4. Able to read and speak English;
5. Aged 18 or older;
6. No suicide ideation or behavior requiring immediate attention;
7. Live in the Rhode Island or Massachusetts area and have a working telephone;
8. Able to provide two contact persons to verify location and in case we are unable to reach the participant during the study;
9. Do not have probation/parole requirements that might interfere with protocol participation.

Primary outcomes:
measure: Initiation of Medication Assisted Treatment
timeFrame: 1 Month Post-Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05609955: Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac
Official title: Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac : Study to Assess Pain And Opioid Consumption in Post Lower Extremity Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Pain, Postoperative
Surgery
Opioid Use
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 48
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 study aims to compare two groups of post-orthopedic patients who received a standard regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and adjuvant magnesium sulfate 30mg/kgBW 1 hour preoperatively. If it is proven useful, it is hoped that pain will be more controlled, reduce pain complications, reduce treatment costs, and reduce the duration of hospital stays.

Detailed description: The study design used was a randomized controlled trial (RCT) with double blinds. Double blind because neither the patient, the lead investigator, nor the investigator on record knew the drug or placebo that was administered. Research subjects were selected consecutively in patients who will undergo lower extremity surgery at the Cipto Mangunkusumo National Central General Hospital. Forty-eight research subjects will be divided into two groups, namely the group given Intravenous Magnesium Sulfate 30 mg/kgBW and the group given a placebo. Research subjects were randomized by type of surgery using randomization software by research assistants. The results of randomization were not known to the patient, the principal investigator, or the researcher taking notes.

This study aims to determine the effect of adding 30 mg/kg body weight of intravenous MgSO4 to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity surgery.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lower extremity orthopedic surgery under general anaesthesia.
* Patients aged 18-60 years.
* Physical status ASA 1-3
* Willing to participate in research.

Exclusion Criteria:

* Patients who are hemodynamically unstable.
* Patients with decreased renal function
* Patients with skeletal muscle disorders.
* Patients with Ketorolac allergy
* Patients with morphine allergy

Primary outcomes:
measure: Visual analogue scale
timeFrame: 24 hour
Secondary outcomes:
measure: Morphine consumption
timeFrame: 24 hour
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo Cental National Hospital
state: DKI Jakarta
Study officials:
References:
Clinical trial NCT02859155: Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Official title: Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: CAIO SERGIO NAHAS
name: SERGIO CARLOS NAHAS
name: Ulysses Ribeiro Junior
name: Carlos Frederico Sparapan Marques
name: Rodrigo Ambar Pinto
name: Antonio Rocco Imperiale
name: Guilherme Cutait Cotti
name: William Carlos Nahas
name: Daher Cezar Chade
name: Dariane Sampaio Piato
name: Fabio Busnardo
name: Ivan Cecconello
First posted: 2016-08-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.

Detailed description: Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.

Eligibility criteria: Inclusion Criteria:

* T4 Colorectal cancer -

Exclusion Criteria:

* Non primary Colorectal cancer -

Primary outcomes:
measure: Survival
timeFrame: 3 years
Secondary outcomes:
measure: Recurrence
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
References:
citation: Nahas CSR, Nahas SC, Ribeiro-Junior U, Bustamante-Lopez L, Marques CFS, Pinto RA, Imperiale AR, Cotti GC, Nahas WC, Chade DC, Piato DS, Busnardo F, Cecconello I. Prognostic factors affecting outcomes in multivisceral en bloc resection for colorectal cancer. Clinics (Sao Paulo). 2017 May;72(5):258-264. doi: 10.6061/clinics/2017(05)01.
Clinical trial NCT04563455: Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With RA
Official title: Investigation of the Relationship Between Grip Endurance, Disability of Upper Extremity and Quality of Life in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Grip Endurance, DASH, Quality of Life, Rheumatoid Arthritis.
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 23
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: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study consists of RA patients.

Brief summary: The aim of this study is to investigate the relationship between grip endurance, disability of upper extremity and quality of life in patients with rheumatoid arthritis.

Detailed description: Upper extremity functions affect the quality of life at different levels in patients with rheumatoid arthritis (RA). In the current literature; it has been shown that grip endurance is associated with upper limb functions. However, there is no study investigating the relationship between grip endurance and quality of life in patients with RA. The purpose of this study is to investigate the relationship between grip endurance, disability of upper extremity, and quality of life in patients with RA.

Eligibility criteria: Inclusion Criteria:

* RA patients were classified according to the ACR 2010 criteria.
* taking regular medication.

Exclusion Criteria:

* having a history of trauma or surgery in the upper limb.
* having neurological, cognitive, or psychiatric diseases.

Primary outcomes:
measure: Static Grip Endurance
timeFrame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
measure: Dynamic Grip Endurance
timeFrame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
Secondary outcomes:
measure: Disability of Upper Extremity
timeFrame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
measure: Quality of Life Parameters
timeFrame: Data collection will continue until December 2019. Data analysis and report preparation will be completed by September 2020.
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
state: Izmir/ Cigli
Study officials:
affiliation: İzmir Katip Celebi University, Faculty of Health Sciences
name: Melissa KÖPRÜLÜOĞLU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206955: Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Fontan Palliation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
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 find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years old.
* Have previously undergone a Fontan Palliation.
* Able to exercise using a supine bike.
* Ability and willingness to provide written consent.
* Undergoing a clinically indicated Cardiac Catheterization

Exclusion Criteria:

* Patients \< 18 years old.
* Current intravenous inotropic drugs.
* Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
* Unable to exercise.
* Pregnancy or lactating.
* Unable or unwilling to consent.

Primary outcomes:
measure: Microvascular endothelial function
timeFrame: 52 weeks
measure: Pulmonary vascular reserve
timeFrame: 52 weeks
Secondary outcomes:
measure: Liver stiffness
timeFrame: 52 weeks
measure: Renal function
timeFrame: 52 weeks
measure: Exercise capacity
timeFrame: 52 weeks
measure: Patient reported quality of life
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander C Egbe, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References: