louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01716728: Identification of Undiagnosed Lysosomal Acid Lipase Deficiency
Official title: Identification of Undiagnosed Lysosomal Acid Lipase Deficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lysosomal Acid Lipase Deficiency
Cholesterol Ester Storage Disease
Keywords: Lysosomal Acid Lipase Deficiency
Cholesterol Ester Storage Disease
Wolman Disease
Lysosomal Storage Disorder
Metabolic Disease
Recessive Inheritance
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Alexion Pharmaceuticals, Inc.
First posted: 2012-10-30
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase deficiency. A group of potential participants will be identified through the PDR. Detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. Participants will be invited to partake in the study via a letter from their Partners care provider with supporting study details. Study participants will be evaluated in a one-time visit. A complete family and medical history will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All participants will be notified of their disease status via letter and phone call from the study staff. If the study participant is diagnosed with LALD through this evaluation, proper follow-up recommendations and referrals will be provided. Our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.


Eligibility criteria: Inclusion Criteria:

* Individuals must have records available in the Partners HealthCare Patient Data Registry

Exclusion Criteria:

* Individuals must not have a diagnosis of Lysosomal Acid Lipase Deficiency

Primary outcomes:
measure: number of patients with previously undiagnosed GD identified Time Frame: up to 2 years Description: Safety Issue?: No number of patients with previously undiagnosed LALD identified
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Katherine B Sims, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05734261: Forced Oscillations Technique During a Metacholine Test in Children
Official title: Interest of Forced Oscillations During a Methacholine Test in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma in Children
Keywords: Infant
Asthma
Diagnosis
Methacholin
Forced oscillation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 112
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Each subject is his or her own control
Primary purpose: DIAGNOSTIC

Brief summary: Asthma is the most common chronic lung disease in children. It affects more than 1 in 10 children in France. The methacholine bronchial challenge test (MBT) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (FEV1), after inhalation of a cumulative dose of methacholine. In children, the measurement of FEV1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. The objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the FEV1 obtained


Eligibility criteria: Inclusion Criteria:

* Age between 6 and 16 years
* FEV1 \> 60%
* Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine
* Child under treatment with inhaled corticosteroids stopped for at least 3 weeks
* Oral consent from the child and at least one of the legal representatives
* Child affiliated or benefiting from a social security plan

Exclusion Criteria:

* Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours
* Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours
* Upper or lower respiratory tract infections within 3 weeks prior to inclusion
* Epilepsy under treatment
* Subject's participation in another interventional study that may alter respiratory function
* Patient unable to give consent, vulnerable

Primary outcomes:
measure: Change in lung impedance measurement
timeFrame: During the procedure
Secondary outcomes:
measure: Average number of trials required for measurement of FEV1 with the spirometry technique
timeFrame: During the procedure
measure: Average number of trials required for impedance measurement by forced oscillation
timeFrame: During the procedure
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: Montpellier Univerty Hospital
name: Stefan MATECKI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03893461: Coagulation System In STereotactic Radiotherapy Of NSCLC
Official title: Impact of Stereotactic Body Radiation Therapy on the Coagulation System in Patients With Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolism
Lung Cancer
NSCLC
Radiotherapy; Complications
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A prospective study of 100 consecutively included lung cancer patients receiving stereotactic body radiation therapy. As standard treatment, which is considered for best practice, the patients receive:

1. 66 Gy/ 3 fractions (F) (new primary peripheral lung cancer), or
2. 50 Gy/ 5 F (new primary central lung cancer), or
3. 45 Gy/ 3 F (peripheral lung cancer relapse after initial surgery or stereotactic body radiation therapy)

Brief summary: The risk of thromboembolism is elevated in lung cancer patients. The present project investigates whether stereotactic body radiation therapy (SBRT) further increases the risk of thromboembolic disease in lung cancer patients.

If coagulation is activated by SBRT, this study could form the basis of new clinical trials investigating whether lung cancer patients may benefit from thromboprophylaxis during and after stereotactic body radiation therapy.

Detailed description: In this study, the patients will have blood samples drawn three times (prior to start of stereotactic body radiation therapy, immediately after stereotactic body radiation therapy completion, four to six weeks after completing stereotactic body radiation therapy). The blood sample at the completion of stereotactic body radiation therapy is an extra compared to normal gathering of blood samples of patients with NSCLC treated with stereotactic body radiation therapy. Also extra glasses with blood will be gathered at each blood sample for storage in a biobank in order to be able to make future analysis on this material.

There is a minimal risk of developing infection or hematoma in connection with blood sampling but we consider this risk to be negligible. The total volume of 120 ml blood drawn over a period of 6 weeks is an inconsiderable risk for the patient.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Planned stereotactic body radiation therapy of lung cancer

Exclusion Criteria:

* Inability to provide informed consent
* Venous thrombosis within the last three months
* Active cancer within the previous year except for lung cancer

Primary outcomes:
measure: Changes in coagulation
timeFrame: From start of SBRT to end and 5 weeks after SBRT
Secondary outcomes:
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Oncology, Odense University Hospital
Study officials:
affiliation: Department of Oncology, Odense University Hospital
name: Stefan S Jeppesen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05484661: Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
Official title: Mechanisms to Reduce Mental and Physical Fatigue Following Exercise Training in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Aging
Keywords: Branched Chain Amino Acids
Exercise
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fatigue is a strong predictor of negative health outcomes in older adults. The research in this study will compared the effects of 8-weeks of branched chain amino acids (BCAAs: dietary supplements commonly taken to improve muscle growth and exercise performance) added to exercise on fatigue compared to exercise with a placebo (an inactive, harmless substance). BCAAs could have an impact on improving fatigue common in older adults, especially when exercising.

Detailed description: Thirty participants will be asked to participate in this research study. They will be randomized (like a flip of a coin) to exercise + a placebo or exercise + BCAAs for 8 weeks. We would like to examine the effects of the 8-week exercise + dietary supplement program on body composition (fat and muscle), physical activity habits, fatigue, and physical performance (such as walking and strength). We would also like to assess whether these outcomes are controlled by changes in markers (kynurenine metabolites) in the skeletal muscle and blood.

Eligibility criteria: Inclusion Criteria:

* Fatigue (participants reporting ≥3 on a 1-10 scale)
* Lack of menses for at least one year for women
* BMI 20-50 kg/m2
* Untrained with regard to structured exercise training (is not currently training more than 2x/week)

Exclusion Criteria:

* Taking an anticoagulant medication that is unable to be discontinued before biopsies
* Allergic to lidocaine
* Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments or training
* Hepatic (LFTs \>2.5xWNL), renal (eGFR\<45), , and uncontrolled psychiatric disease
* Cognitive impairment
* Uncontrolled depression
* Any disease or condition considered to be exclusionary based on the clinical opinion and discretion of the principal investigator

Primary outcomes:
measure: Fatigue
timeFrame: change from baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References:
Clinical trial NCT01779661: Infant Aquatics Neurodevelopment Premature Infants
Official title: The Effect of Infant Aquatics for Neurodevelopment of Premature Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Preterm Birth
Development
Keywords: Neurodevelopment, Infant-Aquatics, Prematurity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: University of Haifa
First posted: 2013-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this research is to examine the effect of Infant Aquatics on the development of and neurodevelopment of preterm and near-term infants, using the GM as prognostic estimation of future development.

Preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (MND) to cerebral palsy (CP), mainly due to developmental brain injury. Infant Aquatics have been found to benefit and promote infant development. The support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants.

The study will compare intervention by Infant Aquatics to infant massage. The intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. Development will be assessed and compared at 3, 8 and 18 months using Infant Motor Pattern method, Griffith developmental scales and Vineland adaptive behavior scales.


Eligibility criteria: Inclusion Criteria:

Major inclusion criteria: Infants who are hemodynamic stable, no seizures or apnea attacks, IVH/PVH grade \< 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. These criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development.

Exclusion Criteria:

infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, IVH/PVH grade \>or =3, with diagnoses of chromosomal abnormalities.

Primary outcomes:
measure: Developmental assessment - a composite of several measures
timeFrame: 3 month
Secondary outcomes:
measure: Developmental assessment - a composite of several measures
timeFrame: 18 month
Other outcomes:
Locations:
city: Ramat-Gan,
country: Israel
facility: Chaim Seba Medical Center
Study officials:
References:
Clinical trial NCT00454961: Effectiveness of Artemether-Lumefantrine for Malaria Treatment of Children at Community Level in Tanzania
Official title: Effectiveness of Artemether-Lumefantrine Treatment Provided by Community Health Worker Against Uncomplicated Malaria in Children Under 5 Years of Age in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Malaria
Plasmodium falciparum
artemether-lumefantrine
effectiveness
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2007-04-02
Enrollment: 200
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.


Eligibility criteria: Inclusion Criteria:

1. Aged \<5 years
2. Weight \>5 kg
3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL
4. Having a history of fever in the preceding 24 h
5. Able to ingest tablets orally
6. Willing and able to attend stipulated follow-up visits
7. With written informed consent from parent/guardian for children to participate in the trial.

Exclusion Criteria:

Presenting with any of the following "danger signs of severe malaria":

1. Convulsions (\>1 episode within previous 24 hours)
2. Lethargic/unconscious

Primary outcomes:
measure: Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine
measure: during 42 days follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Kibaha
country: Tanzania
facility: Kibaha District
Study officials:
affiliation: Karolinska University Hospital
name: Anders Björkman, Professor
role: STUDY_DIRECTOR
References:
citation: Ngasala BE, Malmberg M, Carlsson AM, Ferreira PE, Petzold MG, Blessborn D, Bergqvist Y, Gil JP, Premji Z, Martensson A. Effectiveness of artemether-lumefantrine provided by community health workers in under-five children with uncomplicated malaria in rural Tanzania: an open label prospective study. Malar J. 2011 Mar 16;10:64. doi: 10.1186/1475-2875-10-64.
Clinical trial NCT05073211: St. John's Wort Photodynamic Therapy
Official title: A Randomized Split-face Study of Photodynamic Therapy With St. John's Wort Versus Indole-3-acetic Acid for the Treatment of Acne
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 31
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: a double-blind split-face randomized controlled design
Primary purpose: TREATMENT

Brief summary: The investigators aimed to evaluated the efficacy and safety of SJW-PDT compared to indole-3-acetic acid (IAA)-PDT in the treatment of acne. The investigators also investigated the skin rejuvenating effects of SJW-PDT.


Eligibility criteria: Inclusion Criteria:

* patients with mild to moderate facial acne
* between 25 and 60 years old

Exclusion Criteria:

* history of oral retinoid treatment with the past 6 months
* history of oral antibiotics, topical acne treatment, or skin rejuvenation treatment such as lasers and chemical peeling within the month before the start of the study

Primary outcomes:
measure: acne lesions
timeFrame: 1 and 4 weeks after the last treatment
Secondary outcomes:
measure: sebum secretion rate (μg/cm2)
timeFrame: 1 and 4 weeks after the last treatment
Other outcomes:
measure: erythema index (arbitrary unit)
timeFrame: 1 and 4 weeks after the last treatment
measure: skin texture, wrinkles (arbitrary unit)
timeFrame: 1 and 4 weeks after the last treatment
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jung Won Shin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651911: Fasturtec TLS Treatment / Prophylysis
Official title: A Multicenter Open Label Study of the Efficacy and Safety of Rasburicase in the Treatment of Prophylysis for Tumor Lysis Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tumor Lysis Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open-label study to determine the efficacy and safety of Rasburicase used for the prevention and treatment of tumor lysis syndrome


Eligibility criteria: Inclusion Criteria:

* Chemotherapy planned for at least 3 cycles
* Undergoing cytoreductive chemotherapy for ALL, multiple myeloma or Burkitt's lymphoma stage III or IV
* With a minimum life expectancy of 3 months
* Uric acid \> 8 mg%
* Negative pregnancy test \< or =to 2 weeks and efficient contraceptive method.
* Negative HIV serology \< or =to 4 weeks
* Patient or legal guardian has signed a written informed consent

Exclusion Criteria:

* Hypersensitivity to uricases or any of the excipients
* Known history of G6PD deficiency.
* Previous treatment with Rasburicase or Uricozyme®
* Pregnancy or lactation
* Treatment with any investigational drug within 30 days before planned first Rasburicase administration

Primary outcomes:
measure: To assess the uricolytic response to rasburicase treatment
timeFrame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Secondary outcomes:
measure: To evaluate tumor lysis risk factors, treatments for tumor lysis syndrome and complications of treatment in patients treated prophylactically or therapeutically for tumor lysis syndrome
timeFrame: 5 weeks (3 to 7 days of treatment, with follow-up of 4 weeks after the last study drug injection)
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
Study officials:
affiliation: Sanofi
name: Sharon Chang
role: STUDY_DIRECTOR
References:
Clinical trial NCT06546111: Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
Official title: Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Helicobacter Pylori Infection
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).


Eligibility criteria: Inclusion Criteria:

* Confirmed H. pylori infection through stool antigen test.

  * Patients did not receive prior eradication therapy.
  * Male and female.
  * Age of 18-75 years old.
  * Good mental well-being to clearly understand the study's objectives, advantages and procedures.

Exclusion Criteria:

* Age less than 18 years.

  * Patients with previous H. pylori eradication therapy.
  * Patients with hypersensitivity/allergy to the study medications.
  * Patients with history of using proton pump inhibitor, H2-blocker, antibiotics that affect H.

pylori in the last month.

* Patients with history of using diosmin and/or hesperidin in the last month.
* Patients with history of gastric tumor or gastrointestinal (GI) surgery.
* Patients with concomitant severe disorders; cardiovascular, pulmonary, renal or hepatic, or active malignancy.
* Pregnancy or breastfeeding.
* History of drug misuse or recent alcohol consumption.
* Patients with gall bladder disorders.
* Patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and NSAID (diclofenac) in order to avoid potential pharmacodynamic and pharmacokinetic drug interactions with diosmin.
* Patients on anti-inflammatory drugs and antioxidant drugs.
* Patients with inflammatory conditions (ulcerative colitis, rheumatoid arthritis, etc.).
* Patients with conditions associated with oxidative stress (smoking, COPD, etc.).

Primary outcomes:
measure: Eradication rate of helicobacter pylori infection
timeFrame: At baseline and after 6 weeks of initiation of therapy
Secondary outcomes:
measure: Inflammatory biomarkers suppression
timeFrame: At baseline and after 6 weeks of initiation of therapy
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: National Liver Institute
Study officials:
References: