louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00788970: Shiatsu Adjuvant Therapy And Placebo For Schizophrenia
Official title: Shiatsu Adjuvant Therapy And Placebo For Schizophrenia:a Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: Acupressure
Shiatsu
Schizophrenia
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the current study we will study the effect of adding acupressure (shiatsu) to conventional therapy in treating individuals with schizophrenia.

Detailed description: Acupressure, also known as shiatsu, is a holistic form of medicine originating in Japan but now widely practiced throughout the world. The theory is based on Traditional Chinese Medicine (TCM), which sees meridians of life force (chi) running through the body, and aims to optimize health through manipulating the body into maximal alignment.

We are proposing a randomized double-blind placebo-controlled trial to examine the efficacy of acupressure as adjuvant therapy added to antipsychotics in the treatment of patients with schizophrenia.

The goals of this study are twofold:

1. To assess through the highest standards of empirical research whether acupressure can benefit patients with schizophrenia.
2. To furnish data relevant to the possible physiological mechanisms by which acupressure may produce a therapeutic effect.

Eligibility criteria: Inclusion Criteria:

1. DSM-IV diagnosis of schizophrenia or schizoaffective disorder
2. Ages 18 and over
3. Clinical status stable, as reflected by changes in Brief Psychiatric Rating Scale (BPRS) (Overall \& Gorham, 1961) of less than 20% during a one month period prior to randomization, and at least one month of drug treatment without change of anti-psychotic drug or dosage.
4. Ability to cooperate with 40-minute sessions

Exclusion Criteria:

1. Unstable general medical conditions
2. Active bone fracture or other orthopedic problem
3. Skin condition that renders treatment unsafe or painful
4. Active infection in skin or soft tissues, such as cellulitis
5. Solid tissue malignancy

Primary outcomes:
measure: Brief Psychiatric Rating Scale (BPRS)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Herzog Hospital, Department of Psychiatry
Study officials:
affiliation: Herzog Hospital
name: Pesach Lichtenberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01648270: Buprenorphine Disposition and Cyclosporine
Official title: Influence of Cyclosporine on Buprenorphine Disposition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: buprenorphine
CYP3A
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The determine the effect of cyclosporine on buprenorphine disposition

Detailed description: Subjects studied on four occasions:

1. Intravenous buprenorphine
2. Sublingual buprenorphine
3. Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
4. Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days

Eligibility criteria: Inclusion Criteria:

* 18-50 yr old
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provide informed consent

Exclusion Criteria:

* Known history of liver or kidney disease
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
* Females who are pregnant or nursing
* Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
* Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)

Primary outcomes:
measure: Buprenorphine Plasma Cmax
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06802770: Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida
Official title: Evaluation of Depression and Anxiety Levels of Parents of Children with Spina Bifida
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spina Bifida
Keywords: spina bifida
anxiety
depression
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents whom have a child with spina bifida

Brief summary: Studies in the literature have measured the anxiety and depression levels of parents of children with spina bifida. Additionally, it has been reported that parents of children with non-neurogenic lower urinary tract dysfunction, such as nocturnal enuresis and overactive bladder, have increased levels of anxiety and depression. In this study, the investigators aim to evaluate, for the first time, the effect of urinary system symptoms and findings in children with spina bifida on the anxiety and depression levels of their parents.

Detailed description: Between January 2024 and December 2024, the demographic data of patients with spina bifida under follow-up, as well as the results of dimercaptosuccinic acid (DMSA) static renal scintigraphy, urinary ultrasonography (USG), and voiding cystourethrography (VCUG), which indicate upper urinary tract (UUT) damage, were recorded. Symptom scoring was performed on the primary caregiver of the child, and anxiety and depression scores were calculated. The Hospital Anxiety and Depression Scale (HADS) and the Beck Anxiety Inventory were used to assess these symptoms in the parents. The presence of renal scarring, hydronephrosis, or vesicoureteral reflux (VUR) in the DMSA was considered as UUT damage. Patients were divided into subgroups based on demographic data, UUT damage, history of febrile urinary tract infections (UTIs), incontinence, and the presence of motor deficits. These groups were then compared in terms of anxiety and depression scores.

Eligibility criteria: Inclusion Criteria:

- Having a child with spina bifida

Exclusion Criteria:

- Diagnosis of psychiatric illness

Primary outcomes:
measure: Anxiety Level- Hospital Anxiety Scale
timeFrame: Baseline
measure: Depression Level
timeFrame: Baseline
measure: Anxiety Level- BECK Scale
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Urology Department
Study officials:
affiliation: MARMARA UNİVERSİTY SCHOOL OF MEDİCİNE DEPARTMENT OF UROLOGY
name: CAGRI A. SEKERCİ
role: STUDY_DIRECTOR
References:
Clinical trial NCT04573270: Mesenchymal Stem Cells for the Treatment of COVID-19
Official title: A Pilot Phase Study Evaluating the Effects of a Single Mesenchymal Stem Cell Injection in Patients With Suspected or Confirmed COVID-19 Infection and Healthcare Providers Exposed to Coronavirus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Prophylaxis
Keywords: stem cell therapy
umbilical cord stem cells
amniotic stem cells
stem cells
MSC
Mesenchymal Stem Cell
Medicinal Signaling Cell
Lead sponsor: Thomas Advanced Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: HeartStem Institute
First posted: 2020-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study is a randomized assignment, double-blind, placebo-controlled, multi-arm, multi-site study located at Southern California Hospitals at Culver City and Hollywood.
Primary purpose: TREATMENT

Brief summary: This double blind, placebo controlled, multi-arm, multi-site study investigates the safety and efficacy of stem cell therapy for the treatment of patients admitted to hospital suffering complications from COVID-19 and the treatment of healthy subjects (healthcare providers) for prophylactic effect following those patients.

Detailed description: Recent preliminary data from Wuhan/China have claimed that intravenous injections of mesenchymal stem cells derived from human umbilical chords have resulted in complete recovery of COVID-19 infected elderly patients with respiratory failure.

This study investigates the efficacy and safety of a single umbilical cord derived stem cell intravenous injection in patients with suspected or confirmed COVID-19 infection with fever and respiratory illness.

A second arm will test efficacy and safety of a single umbilical cord derived stem cell intravenous injection to healthcare providers at high exposure rates to COVID-19 infection.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Ability to provide informed consent

Exclusion Criteria:

* Active or recent malignancy (within last 2 years)
* Inability to provide informed consent
* Current enrollment in any other COVID-19 treatment study

Primary outcomes:
measure: Survival Rates
timeFrame: 30 Days
measure: Contraction Rates
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Southern California Hospital at Culver City / Southern California Hospital at Hollywood
state: California
Study officials:
affiliation: HeartStem Institute, Southern California Hospital at Culver City
name: Ernst R Von Schwarz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180570: SALT - Success of Active Versus Passive Lead Fixation of Atrial Pacing/Sensing Electrodes
Official title: Scandinavian Atrial Lead Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Bradycardia
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 385
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: Randomised Comparison with regards to complication rate and electrical measurements of atrial leads with different fixation mechnism

Detailed description: This investigation will study and compare 3 types of electrically identical, commercially available FineLine II Sterox leads with different fixation mechanisms. This trial has been designed to primarily study the difference in repositioning rate between active and passive fixation (straight and J-shaped) leads, if any. It will also monitor and document the behavior of the study leads, with special reference to electrical parameters and handling. Normal measurements are taken at pre-dicharge, 1-month 3-month and 12-month follow-up

Eligibility criteria: Inclusion Criteria:

* Patients selected for participation in this investigation should be candidates for permanent pacemaker implantation chosen from the investigator's general patient population without regard for race or sex. Furthermore, these patients should, in the physician's general opinion, benefit from permanent pacemaker implantation with one of the study leads. Patients should be geographically stable and available for routine follow-up visits throughout the duration of the study. Patients must also be able and willing to provide informed consent.

Exclusion Criteria:

* Patients who previously went through heart surgery should be excluded from the study.

Primary outcomes:
measure: The primary objective of this study is to compare repositioning rate due to threshold > 3.0 V @ 0.5 ms or P-wave < 0.8 mV between FineLine II Sterox 4480 and 4470, and between 4456 and 4470.
Secondary outcomes:
measure: 1. Other complications (Safety). To compare other lead related complication rates such as perforation, lead fracture and failure to implant. 2. Electrical properties
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Sahlgrenska Sjukhuset i Göteborg Sweden,
Study officials:
affiliation: Sahlgrenska Sjukhuset i Göteborg Sweden
name: charles kennergren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725070: Phase 0/1 Study of 212Pb-NG001 in mCRPC
Official title: Phase 0/1 Theragnostic Study in Patients With Metastatic Castration Resistant Prostate Cancer in Need of Salvage Therapy, Selected by 18F-PSMA-PET Imaging and Treated by Alpha-therapeutic Radioligand 212Pb-NG001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: ARTBIO Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the imaging feasibility and safety of 212Pb-NG001.

Detailed description: This is a single site, open label, non-randomized, non-controlled intervention study with an initial microdosing run-in part (phase 0), followed by a conventional dose-escalation phase 1 part.

Eligibility criteria: Key Inclusion Criteria:

* ECOG performance status of 0 to 2
* Life expectancy \>6 months
* Histological, pathological, and/or cytological confirmation of prostate cancer
* Metastatic castration resistant prostate cancer
* Failure of conventional treatment or such treatment not available/accepted by patient
* PSMA avid mCRPC lesions confirmed by PSMA PET/CT
* Adequate hematopoietic, kidney and liver function

Key Exclusion Criteria:

* Concurrent or other cancer diagnosis last two years, except for carcinoma in situ
* Concomitant diseases not compatible for radioactive therapy
* Previous PSMA-targeted radioligand therapy
* Concurrent serious (as determined by the Principal Investigator) medical conditions

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Feasibility of SPECT/CT gamma camera imaging for uptake of 212Pb-NG001
timeFrame: Up to 28 days
Secondary outcomes:
measure: Safety and tolerability
timeFrame: Up to 28 days
measure: Body clearance
timeFrame: Up to 2 days
measure: Therapeutic effect on prostate cancer as indicated by decreasing serum PSA and/or ALP
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kjetil Berner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01219270: Radiocontrast Media Induced Hyponatremia
Official title: Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Coronary Intervention
Keywords: Radiocontrast media,
hyponatremia
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who receive contrast media during percutaneous coronary intervention

Brief summary: Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.

Detailed description: Radiocontrast media after percutaneous coronary interventioncan lead to increased osmolaliry of plasma, which results in translocational hyponatremia.

The investigator will exam the incidence of hyponatremia after percutaneous coronary intervention, and will evaluate the underlying mechanism related to hyponatremia including translocational hyponatremia, or osmotic natriuresis.

Eligibility criteria: Inclusion Criteria:

* Patients who receive contrast media during percutaneous coronary intervention

Exclusion Criteria:

* Patients who have sensitivity to contrast media.
* Liver cirrhosis
* Hypothyroidism
* SIADH
* Patients who receive IVIG or mannitol.

Primary outcomes:
measure: Incidence of contrast media induced translocational hyponatremia
timeFrame: 01/10/2010-28/02/2011
Secondary outcomes:
measure: Renal function is affected by the incidence of translocational hyponatremia.
timeFrame: 01/10/2010-28/02/2011
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
affiliation: Gachon University Gil Medical Center
name: Sejoong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aronson D, Dragu RE, Nakhoul F, Hir J, Miller A, Boulos M, Zinder O, Green J, Mittleman MA, Markiewicz W. Hyponatremia as a complication of cardiac catheterization: a prospective study. Am J Kidney Dis. 2002 Nov;40(5):940-6. doi: 10.1053/ajkd.2002.36324.
Clinical trial NCT01649570: Safety and Efficacy of Insulin Aspart in Type 2 Diabetes
Official title: An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-07-25
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks
* HbA1c below or equal to 11.0%
* BMI (body mass index) below 30 kg/m\^2

Primary outcomes:
measure: Incidence of hypoglycaemia
Secondary outcomes:
measure: Incidence of adverse events (AEs)
measure: Clinical laboratory tests: Haematology and biochemistry
measure: Insulin antibodies
measure: Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Novo Nordisk A/S
name: Henning Andersen
role: STUDY_DIRECTOR
References:
Clinical trial NCT03785470: Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle
Official title: Vascular and Metabolic Consequences of Adopting a Westernized Lifestyle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Diseases
Keywords: arterial stiffness
endothelial dysfunction
fructose
physical inactivity
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if short-term adoption of a Westernized lifestyle characterized by physical inactivity and increased consumption of fructose will result in metabolic and vascular dysfunction. Healthy individuals aged 18-45 years old will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption. Augmented fructose consumption will be achieved via commercially available soda beverages which are high in fructose. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

Detailed description: Men and women who regularly engage in \>10,000 steps per day, age 18-45 years, body mass index \< 30 kg/m2, and with no history of chronic disease will be recruited. Subjects who are eligible will undergo an acute period of physical inactivity (10 days) coupled with increased fructose consumption (6 cans/day). Physical activity levels will be assessed via a pedometer to quantify if individuals achieve \<5000 steps/day. Vascular and metabolic function measures will be performed before and after the 10-day intervention.

Eligibility criteria: Inclusion Criteria:

* Men and women who regularly engage in \>10,000 steps per day
* Age 18-45 years
* Body mass index \< 30 kg/m2
* No history of chronic disease

Exclusion Criteria:

* Known cardiovascular disease including hypertension, heart failure, coronary artery disease, and stroke
* Renal or hepatic diseases
* Active cancer
* Autoimmune diseases
* Current use of immunosuppressant therapy
* Excessive alcohol consumption (\> 14 drinks/week for men and \>7 drinks/week for women)
* Current tobacco use
* Current pregnancy
* Diagnosis of type 2 diabetes
* Regular consumption of \>2 non-diet sodas/day

Primary outcomes:
measure: Change in Insulin-stimulated leg blood flow
timeFrame: this will be assessed at baseline and at the final visit (10 days)
Secondary outcomes:
measure: Change in Brachial artery flow mediated dilation (FMD)
timeFrame: this will be assessed at baseline and at the final visit (10 days)
measure: Change in carotid femoral pulse wave velocity (cfPWV)
timeFrame: this will be assessed at baseline and at the final visit (10 days)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Camila Manrique Acevedo, MD
role: PRINCIPAL_INVESTIGATOR
References: