louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04845776: Vitamin/Mineral Supplement for Children With Autism
Official title: Vitamin/Mineral Supplement for Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Southwest College of Naturopathic Medicine
First posted: 2021-04-15
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants with ASD will receive the vitamin/mineral supplement
Primary purpose: TREATMENT

Brief summary: This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism.

Detailed description: This is an open-label 3 month clinical trial of a vitamin/mineral supplement designed for children with autism. There will be pre/post assessments of autism symptoms,GI symptoms, and laboratory tests. Typically-developing children will be assessed at baseline only (no treatments) for comparison.

Eligibility criteria: Inclusion Criteria:

1. Child age 3-17 years (up until 18th birthday)
2. Previous diagnosis of ASD by a psychiatrist, psychologist, or developmental pediatrician
3. Verification of diagnosis by ASU staff using the Autism Diagnostic Interview-Revised.
4. No changes in any medical, nutritional, dietary, behavior, or other treatment in the last three months, and a willingness to avoid any changes during the study
5. Participant is able to wear a mask during the short visit for the blood draw.

Exclusion Criteria:

1. Parent/guardian is unable to read or speak English fluently.
2. Use of a vitamin/mineral supplement in the past 3 months
3. Previous adverse reaction to a vitamin/mineral supplement
4. Unstable, poor health; seizure disorder that is not responsive to treatment or not on stable management or complex type; or other health conditions that would significantly increase their risk of adverse effects (per physician clinical judgement)
5. Use of any medication which has a contra-indication for one of the ingredients in the vitamin/mineral supplement
6. A major single-gene disorder such as Fragile X, Down's Syndrome.
7. Major brain malformation
8. Tube feeding
9. Current participation in other clinical trials
10. Females who are pregnant or who are sexually active without effective birth control.
11. Clinically significant abnormalities at baseline on two blood safety tests: Comprehensive Metabolic Panel and Complete Blood Count with Differential.
12. Psychotropic medication use which can affect neurotransmitter levels/function - Current or within past 2 months

Primary outcomes:
measure: Parent Global Impressions of Autism
timeFrame: assessed at the 3 months (end of treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: James B Adams, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05231876: French Wilson Disease Registry
Official title: Registre Wilson France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson Disease
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2022-02-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suffering from Wilson disease

Brief summary: This registry concerns adults and children with Wilson's disease. The collection of a large amount of data will allow a better understanding of the epidemiology of this rare disease, in particular the age of onset according to the hepatic or hepato-neurological forms, but also the geographical distribution of patients consulting in France. This database will also make it possible to know all the therapies prescribed to "Wilsonian" patients. The genetic study of these patients will make it possible to specify the various genetic mutations involved in Wilson's disease. The information (clinical, biological, radiological and genetic) relating to the disease will be entered by a doctor or a professional specialising in Wilson's disease.


Eligibility criteria: Inclusion Criteria:

* All patients suffering from Wilson disease

Exclusion Criteria:

* Lack of written consent from the patient or their legal representative

Primary outcomes:
measure: Recording of pathology-related information on the Wilson Register
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Fondation Adolphe de Rothschild
state: Ile-de-France
Study officials:
References:
Clinical trial NCT01069276: Prehospital Transcranial Duplex in Patients With Acute Stroke
Official title: Prehospital Transcranial Duplex in Patients With Acute Stroke
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Keywords: Stroke
prehospital ultrasound
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical signs of acute stroke in the teritorial of the middle cerebral artery

Brief summary: The aim of the study is to investigate patients with acute stroke prehospital with transcranial duplex ultrasound to detect an infarct of the middle cerebral artery.

Detailed description: The investigation of the patients will be done by an anaesthesiologist who is part of the prehospital medical treatment in Germany. The main question is, wether a non neurologist can detect an infarction of the middle cerebral artery in a short time an lead the patient to the indicated clinic.

Eligibility criteria: Inclusion Criteria:

* clinical signs of acute stroke
* possibility of TCD

Exclusion Criteria:

* acute interventions for vital signs required

Primary outcomes:
measure: Prehospital detection of an infarction of the middle cerebral artery in patients with acute stroke
timeFrame: 5 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg-University Mainz
Study officials:
References:
Clinical trial NCT05061576: Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
Official title: Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2021-09-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly \>12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.6.
* MELD \< 25
* Understanding the Swedish language.
* Signed informed consent.

Exclusion Criteria:

* Performance status ≥3.
* Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.
* Previously liver transplanted
* Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.

Primary outcomes:
measure: Change in quality of life summary score, as measured with the CLDQ tool
timeFrame: 3 months
Secondary outcomes:
measure: Frailty
timeFrame: 3 months
measure: MELD
timeFrame: 3 months
measure: Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Hannes Hagström, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04382976: The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants
Official title: The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants at the Neonatology Centre of Vilnius University Hospital Santaros Klinikos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrocalcinosis
Preterm Infant
Lead sponsor: Vilnius University
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 171
Sex: ALL
Minimum age (years): 23
Maximum age (years): 31
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is a group of very preterm infants less than 32 weeks of gestation during hospitalisation at the Neonatology Centre.

Brief summary: The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.

Detailed description: Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.

The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.

Eligibility criteria: Inclusion Criteria:

* preterm infants of the gestational age of \<32 weeks;
* parental consent acquired.

Exclusion Criteria:

* death before 28 days of age;
* congenital defects;
* no kidney ultrasound results;
* no parental consent.

Primary outcomes:
measure: The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation
timeFrame: 3 years
Secondary outcomes:
measure: Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.
timeFrame: 3 years
measure: To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.
timeFrame: 6 and 12 months of corrected age
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University, Neonatology Centre
Study officials:
affiliation: Vilnius University
name: Rasa Garunkstiene, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05052476: First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
Official title: First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colic
Lead sponsor: Astel Medica
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.

The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.


Eligibility criteria: Inclusion Criteria:

* Full term healthy infant (37-41 weeks amenorrhea)
* Birth weight \>2750 g
* Aged between 2 and 8 weeks
* Presenting symptoms of infant colic as defined by Rome IV criteria by Zeevenhoven et al. 2017
* Signed written informed consent of the parent/tutor

Exclusion Criteria:

* Premature birth
* Using probiotics as a treatment, different from the one that could contain the formula at the time of study recruitment
* Acute or chronic illness as judged by the investigator which avoids the participation to the study .
* Parents unable to understand the requirements of study participation as judged by the investigator
* Malnutrition as judged by a body weight/height ratio \<5 %

Primary outcomes:
measure: Change in parent quality of life (QoL) score
timeFrame: Change from baseline parent QoL score at 28 days
Secondary outcomes:
measure: Change of daily median crying time
timeFrame: Change from baseline daily median crying time at 28 days
measure: Change of the number of crying
timeFrame: Change from baseline number of crying at 28 days
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT00581776: Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Official title: Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mantle Cell Lymphoma
Keywords: Untreated Mantle Cell Lymphoma
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 30
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: Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Detailed description: Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed CD20+ mantle cell lymphoma, with measurable or evaluable disease, no prior chemotherapy, immunotherapy or radiotherapy except for 1 cycle of CHOP-like chemotherapy.

Exclusion Criteria:

* Patients with known CNS disease, known HIV infection, grade 2 or greater peripheral neuropathy, history of myocardial infarction in last 6 months, or patients who are Hepatitis B Surface Antigen positive.

Primary outcomes:
measure: Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR).
timeFrame: At completion of induction therapy (21 weeks)
measure: Complete Response Rate (CR) at the End of Induction Chemotherapy
timeFrame: at 21 weeks
Secondary outcomes:
measure: 3 Year Progression Free Survival
timeFrame: 36 months
measure: 3 Year Overall Survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University Of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Brad S Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00679276: Treatment Outcomes of Vaginal Prolapse Repair
Official title: Treatment Outcomes of Vaginal Prolapse Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaginal Prolapse
Keywords: vaginal prolapse
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-05-16
Enrollment: 291
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having prolift surgery at William Beaumont Hospital by Dr. Lary Sirls, Dr. Predeep Nagaraju, and Dr. Kenneth Peters.

Brief summary: Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.

Detailed description: Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital. Preoperative, intraoperative and post-operative data will be collected from the hospital and physician medical records. A questionnaire will be mailed to patients whose charts have been reviewed to assess urinary and bowel function, satisfaction with treatment and changes in sexual function. Completion of the questionnaire is voluntary.

Eligibility criteria: Inclusion Criteria:

* Women having Prolift repair at William Beaumont Hospital

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: William Beaumont Hospitals
name: Predeep Nagaraju, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01779076: Oxygen Level and Safe Emergence From Anesthesia
Official title: Emergence From General Anesthesia With Laryngeal Mask Airway and Increased End-expiratory Pressure Using 30% Oxygen is as Safe as With 100% Oxygen But Reduces the Area of Post Operative Atelectasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study is Postoperative Pulmonary Atelectacis
Lead sponsor: Region Västmanland
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 59
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Using a protective ventilation strategy during general anesthesia from pre-oxygenation to emergence and selecting patients without risk of a difficult airway or intubation, a lower fraction of inspiratory oxygen (FIO2) can be used during extubation. This might reduce the postoperative area of atelectasis without desaturations becoming more common.


Eligibility criteria: Inclusion Criteria:

* No sign of difficult airway or intubation
* Day case surgery in total intravenous anesthesia with laryngeal mask airway without adding regional anesthesia of plexus brachialis or muscle relaxant.
* Body mass index less than 35.
* American Society of Anesthesiologists physical status (ASA) class I-III

Exclusion Criteria:

* Body mass index 35 or higher
* Increased risk of aspiration
* Obstructive sleep apnea syndrome
* Procedures during surgery making a former easy airway a difficult airway
* Need for opioids after extubation
* Hypothermia

Primary outcomes:
measure: Area of atelectasis
timeFrame: 30 minutes
Secondary outcomes:
measure: Peripheral oxygen saturation (SpO2)
timeFrame: 3 hours
Other outcomes:
Locations:
city: Köping
country: Sweden
facility: Västmanlands sjukhus Köping
state: Västmanland
Study officials:
affiliation: Landstinget i Värmland
name: Mats Enlund, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Edmark L, Auner U, Lindback J, Enlund M, Hedenstierna G. Post-operative atelectasis - a randomised trial investigating a ventilatory strategy and low oxygen fraction during recovery. Acta Anaesthesiol Scand. 2014 Jul;58(6):681-8. doi: 10.1111/aas.12322. Epub 2014 Apr 11.
Clinical trial NCT02022176: Modulation of Metabolic Rate by Inorganic Nitrate
Official title: Dietary Inorganic Nitrate: Effects on Metabolic Rate, Reactive Oxygen Species Production, Glucose Uptake and Primary Myotube Respiration.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resting Metabolic Rate
Keywords: Nitrate
Nitrite
Nitric oxide
Resting metabolic rate
Glucose uptake
Insulin sensitivity
Reactive oxygen species production
inorganic nitrate
Sodium nitrite infusion
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Swedish Heart Lung Foundation
First posted: 2013-12-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effects of sodium nitrate on resting metabolic rate, glucose uptake and formation of reactive oxygen species in humans.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers

Exclusion Criteria Chronic medication Vegetarian Nicotine Users Known metabolic disease

Primary outcomes:
measure: Resting metabolic rate
timeFrame: day 4
Secondary outcomes:
measure: Thyroid hormone status
timeFrame: day 4
measure: Glucose uptake
timeFrame: day 4
measure: Nitrite infusion
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
References:
citation: Larsen FJ, Schiffer TA, Borniquel S, Sahlin K, Ekblom B, Lundberg JO, Weitzberg E. Dietary inorganic nitrate improves mitochondrial efficiency in humans. Cell Metab. 2011 Feb 2;13(2):149-59. doi: 10.1016/j.cmet.2011.01.004.
Clinical trial NCT04542876: Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection
Official title: Efficacy and Safety of Guduchi Ghan Vati in the Management of Asymptomatic COVID-19 Infection: An Open Label Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
First posted: 2020-09-09
Enrollment: 46
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: The emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.There have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.Therefore, present feasibility study of the safety and efficacy of Guduchi Ghan Vati was conducted in asymptomatic patients with COVID-19


Eligibility criteria: Inclusion Criteria:

* All hospitalised cases above 18 years of age,
* Diagnosed with Covid-19
* Asymptomatic at the time of admission
* Agree to give consent

Exclusion Criteria:

* Symptoms relating to Covid-19
* Severe vomiting
* Respiratory failure or requiring mechanical ventilation
* Patients having alanine transaminase (ALT) or aspartate transaminase (AST) \> 5 times the upper range of normal limits
* Patients with Covid-19 in critical condition or ARDS or NIAD 8 -point ordinal score-2
* Patients with uncontrolled diabetes mellitus
* Malignant,
* Chronic renal failure or
* On immunosuppressive medication

Primary outcomes:
measure: Virologic clearance
timeFrame: 14 days
Secondary outcomes:
measure: Hospital Stay
timeFrame: 14 days
measure: Clinically relevant adverse effects
timeFrame: 14 days
measure: Laboratory tests
timeFrame: change from baseline to 14 days
Other outcomes:
Locations:
city: Jodhpur
country: India
facility: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
state: Rajasthan
Study officials:
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
name: Abhimanyu Kumar
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Neha Sharma
role: STUDY_DIRECTOR
References: