louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05799508: Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
Official title: Consequences of COVID-19 Infection for Child Health and Wellbeing: Protocol for a Prospective, Observational, Longitudinal Study in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long COVID
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 1200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients diagnosed with COVID-19 and admitted to the hospitals and/or assessed in primary care among our Institution. Patients will be identified from existing local cohorts.

Inclusion criteria:

* Children aged 0-18 years
* The child sought/needed primary or secondary medical care for COVID-19
* Laboratory (RT-PCR,) \[18\]
* 28 days - 3 months from the onset of COVID-19 symptoms
* Parent's/carer's/guardian's consent to participate The survey for paediatric follow-up is based on the previously developed adult questionnaire. The survey has been adapted to specific age groups to identify specific symptoms in children.

Brief summary: Prospective follow-up of children with SARS-CoV-2


Eligibility criteria: Inclusion Criteria:

* Children aged 0-18 years
* The child sought/needed primary or secondary medical care for COVID-19
* Laboratory (RT-PCR,) \[18\]
* 28 days - 3 months from the onset of COVID-19 symptoms
* Parent's/carer's/guardian's consent to participate

Exclusion Criteria:

* adults

Primary outcomes:
measure: number of children developing long covid
timeFrame: up to 36 months
Secondary outcomes:
measure: duration and characteristics of children with long covid, also according to variants
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Gemelli
Study officials:
References:
Clinical trial NCT03490708: A Clinical Study of Tranilast in the Treatment of Mucinoses
Official title: A Clinical Study of Tranilast in the Treatment of Mucinoses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Mucinoses
Keywords: Mucinoses
Tranilast
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-04-06
Enrollment: 56
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: 56 participants with Mucinoses will be selected to receive treatment of tranilast. After a period of time ,the investigators can determine the efficacy of the drug by detecting the the thickness and area of skin before and after treatment.

Detailed description: 56 participants with Mucinoses will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos,the thickness and area of skin lesions by ultrasound and magnetic resonance,and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast (0.1g each time, three times a day,12 months) treatment, participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, and every three months to retest lesion thickness and area. With 3 month as a time point, participants were observed for four points. After the experiment, the experimental data will be arranged and the data of the thickness and area change of skin lesions will be statistically processed to determine whether it is meaningful.

Eligibility criteria: Inclusion Criteria:

1. Clinical and histopathological examination has been proved to be Mucinoses;
2. Ultrasound and magnetic resonance detection found that the skin was thickened.

Exclusion Criteria:

1. With a liver or kidney disease, or accompanied by a severe infection;
2. Poor control of primary disease;
3. With mental disease.

Primary outcomes:
measure: Measure the volume change of skin lesions by ultrasound
timeFrame: This experiment will last for 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00457808: Rapamycin Therapy for Patients With Tuberous Sclerosis Complex and Sporadic LAM
Official title: Rapamycin Therapy of Angiomyolipomas in Patients With Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tuberous Sclerosis
Lymphangioleiomyomatosis
Keywords: TSC and LAM
Tuberous Sclerosis Complex and sporadic LAM
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: The LAM Foundation
name: Tuberous Sclerosis Alliance
First posted: 2007-04-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine if rapamycin reduced angiomyolipomata volume in patients with tuberous sclerosis complex or lam.

Detailed description: The study design was an open label, phase I/II trial of sirolimus for one year followed by one year off therapy.Patients were seen at baseline,at two weeks to four weeks, and at 2,4,6,9,12,18 and 24 months. Angiomyolipomata imaging was performed at all but the two to four week visit. Complete pulmonary function tests and six-minute walk were obtained at baseline,6 or 9 month, 12 and 24 month visits, while simple spirometry only was performed at all other visits.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with angiomyolipomas and have either Tuberous Sclerosis complex or Lymphangioleiomyomatosis
* Between the gaes of 18 and 65 years
* Competency to voluntarily consent
* Clinically definite diagnosis of tuberous sclerosis or S-LAM
* Adequate contraception
* At least one angiomyolipoma of 1 cm or greater in largest diameter

Exclusion Criteria:

* Use of continuous supplemental oxygen
* Concurrent infection
* Recent surgery
* Ongoing or planned pregnancy
* Lactation
* Use of an investigational drug within the last 30 days of study entrance

Primary outcomes:
measure: Volume of Angiomyolipomata
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: John Bissler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bissler JJ, McCormack FX, Young LR, Elwing JM, Chuck G, Leonard JM, Schmithorst VJ, Laor T, Brody AS, Bean J, Salisbury S, Franz DN. Sirolimus for angiomyolipoma in tuberous sclerosis complex or lymphangioleiomyomatosis. N Engl J Med. 2008 Jan 10;358(2):140-51. doi: 10.1056/NEJMoa063564.
Clinical trial NCT06543823: ST250 as a Therapeutic Option for Head & Neck Reconstruction
Official title: The Use of Suprathel®250 as a Novel Therapeutical Option for Mucosal Healing in Head and Neck Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tonsillitis
Keywords: PLA membrane
Biodegradable membrane
Synthetic
Tonsillectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: An interventional group with the application of the SupraTHEL 250 membrane and the control group with no membrane applied on the wound bed
Primary purpose: TREATMENT

Brief summary: To assess the use of SupraThel 250 for mucosal reconstruction in the Head \& Neck region. The membrane will be applied after tonsillectomy procedures and compared to bare wounds' healing

Detailed description: After tonsillectomy procedures, the wound is usually left bare to heal. This causes severe pain postoperatively and postoperative hemorrhage. SupraTHEL 250 is a synthetic biodegradable PLA membrane which is proven as a skin membrane in burn wounds with excellent result. We therefore hypothesize that the use opf SupraTHEL 250 after tonsillectomy procedures will allow for faster , less painful healing of the wound bed which allows for a better quality of life for the patients.

Eligibility criteria: Inclusion Criteria:

* recurrent episodes of tonsillar infection

Exclusion Criteria:

* children
* pregnant/ breastfeeding women
* patients undergoing chemo / radiotherapy

Primary outcomes:
measure: Pain scores
timeFrame: upto 5 days postoperatively
Secondary outcomes:
measure: Quality of Life , Tonsillectomy Outcome Inventory - 14
timeFrame: 5 days Postoperative
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: MarienHospital
state: Baden-Wurttemberg
Study officials:
affiliation: Cairo University
name: Alaa Emara
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03392623: DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
Official title: DNA Methylation in Malar Melasma and Its Change by Sunscreen, Retinoic Acid and Niacinamide.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Melasma
Keywords: Epigenetics, Malar melasma,
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: BACKGROUND: Malar melasma has a chronic and recurrent character that may be related with epigenetic changes.

Detailed description: OBJECTIVE: Recognize the DNA methylation status of the malar melasma and perilesional skin, and its change after treatment with 50 SPF sunscreen (S), 4% niacinamide (N), or 0.025% retinoic acid (RA). METHODS: Fifty-six lesion of 28 female patients without treatment were clinically evaluated, as also the expression of DNA methyl transferases 1 and 3 by real time-PCR (polymerase chain reaction amplification), immunohistochemistry and immunofluorescence. It was initially quantified and after 8 weeks of treatment with S, RA and N. RESULTS: Relative expression of DNA methyl transferases were significantly elevated compared with unaffected skin in all subjects indicating hypermethylation of DNA. Hypermethylation decreased by S (7 vs 3 times relative expression, p\<0.05), RA (7 vs 2 times relative expression p\<0.05), and N (7 vs 1 relative expression p\<0.01) correlated with clinical improvement, this was also supported by immunohistochemistry and immunofluorescence. CONCLUSIONS: The investigators found hypermethylation of DNA in melasma lesions. Environmental factors such as sun radiation may induce DNA hypermethylation triggering hyperpigmentation trough the activation of pathways regulated by epigenetic modifications. Thus, decreasing methylation by sunscreen protection and the genetic transcription modification through N and RA, may allow their clinical improvement regardless its depigmenting effect.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of malar melasma by a specialist. No previous treatment at the beginning of the study.

Exclusion Criteria:

Use of medications associated with the development of melasma. Pregnant or lactating patients. Presence of concomitant diseases associated with the development of melasma. or other facial hyperpigmentations (thyroid, liver).

Have received treatment in the last 2 months. Regular use of sunscreen.

Primary outcomes:
measure: improve in the level of DNA methylated
timeFrame: 8 weeks
Secondary outcomes:
measure: improve in the clinical severity of melasma
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06500923: Narrow-diameter Implants Replacing Maxillary Lateral Incisors
Official title: Five Year Outcomes at Two Narrow-diameter Implants to Replace Congenital Missing Maxillary Lateral Incisors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant Failed
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2024-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)

Brief summary: To present the 5-year clinical, radiographic, and aesthetic outcomes in patients with congenitally missing lateral incisors (MLIs) rehabilitated with two narrow-diameter implants (NDIs).


Eligibility criteria: Inclusion Criteria:

* Patients affected by congenital missing with uni- or bilateral maxillary lateral incisors (i.e. 12 and/or 22)
* Patients with systemic health or controlled medical conditions
* Patients arrested skeletal growth as documented by two body height measurements at least one year apart not indicating continuous growth (Jensen, 2019)
* Written Informed Consent

Exclusion Criteria:

* Patients contraindications to implant therapy (Hwang \& Wang, 2006, 2007) including
* Heavy smoking: \>20 cigarettes/day
* Poor oral hygiene
* Compromised compliance
* Periodontally compromised conditions
* Patients with MLI's with the canine situated in the MLI region

Primary outcomes:
measure: Peri-implant marginal bone level changes
timeFrame: 1 year
Secondary outcomes:
measure: Implant Survival rate (%)
timeFrame: 1-3-5 year
measure: Aesthetic outcomes
timeFrame: 1-3-5 year
measure: PROMs
timeFrame: 1-3-5 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Hospital Copenhagen
Study officials:
affiliation: Copenhagen University Hospital, Copenhagen, Denmark
name: Simon Storgaard Jensen, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT06468423: Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
Official title: Comparison of Deferasirox and Desferoxamine in Patients of β-Thalassemia Major With Iron Overload
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pateints of β-thalassemia Major With Iron Overload
Lead sponsor: RESnTEC, Institute of Research
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 142
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to compare deferasirox and desferrioxamine in terms of mean serum ferritin levels in patients of β-thalassemia major having Iron overload. Choosing an effective iron chelator is crucial to increasing iron chelation therapy compliance. Not much local data exists in Pakistan comparing the effectiveness of deferasirox (DFX) and desferrioxamine (DFO), so, this study would be helpful in providing baseline data and formulating new protocols for iron chelation therapy, in which DFX may be a useful oral alternative to parenteral DFO.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of β-thalassemia major (as per medical record or confirmed by hemoglobin electrophoresis)
* Iron overload (serum ferritin level above 1000 µg/L)

Exclusion Criteria:

* Patients with other transfusion-dependent anemias
* Thalassemia major with cardiomyopathy or arrhythmia.
* Chronic renal failure
* Chronic liver disease (ALT \>200 IU)
* Hhypersensitivity to deferasirox or desferrioxamine
* Patients already on combined chelation therapy

Primary outcomes:
measure: Mean Serum Ferritin Levels
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Multan
country: Pakistan
facility: Thalassemia Center of Hematology Department, The Children's Hospital & The Institute of Child Health
state: Punjab
Study officials:
References:
Clinical trial NCT01843023: Extended Release Naltrexone for Opioid-Dependent Youth
Official title: Health Services Research: Extended Release Naltrexone for Opioid-Dependent Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Dependence
Keywords: opioid dependence
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-04-30
Enrollment: 288
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare 6-month treatment outcomes for 15-21 year old opioid-dependent youth receiving extended release naltrexone (XR-NTX) v. Treatment as Usual (TAU).

Detailed description: This proposed study is a 6-month, two-group randomized clinical trial of XR-NTX v. TAU for 340 opioid-dependent youth ages 15-21. The study will be conducted at Mountain Manor Treatment Center, a community drug treatment program in Baltimore. TAU will consist of buprenorphine treatment of opioid withdrawal followed by counseling with or without continued buprenorphine.

Eligibility criteria: Inclusion Criteria:

* Meets Diagnostic and Statistical Manual-IV criteria for opioid dependence, physiologic subtype;
* Within 3 days of admission to MMTC;
* Age between 15 and 21, inclusive;
* Able and willing to provide informed consent to be randomly assigned to XR- NTX or TAU; and for participants under 18 years of age, parental or guardian consent and participant assent.

Exclusion Criteria:

* Liver function test levels (Alanine Transaminase, Aspartate Transaminase) four times greater than normal;
* Unstable medical or psychiatric illness (e.g., schizophrenia) that might make participation hazardous;
* History of serious suicide attempt in the past 6 months;
* History of allergic reaction to naloxone, and/or naltrexone;
* Current chronic pain condition for which opioids are deemed necessary for ongoing care;
* blood coagulation disorder (e.g., hemophilia);
* Body Mass Index \> 40;
* If female, pregnant, lactating, unwilling or unable (due to parental objection) to use FDA-approved contraceptive methods;
* meeting DSM-IV criteria for benzodiazepine dependence

Primary outcomes:
measure: Opioid Use at 6 Month Follow-up
timeFrame: 6 months
Secondary outcomes:
measure: Treatment Retention
timeFrame: 6 months
measure: Monetized Healthcare Utilization
timeFrame: 6 months
measure: HIV Sex Risk Behaviors
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute
state: Maryland
city: Baltimore
country: United States
facility: Mountain Manor Treatment Center
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Shannon G Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02559323: LIVESTRONG Survivorship Care Plan: Continued Data Collection and Follow Up Survey
Official title: LIVESTRONG Survivorship Care Plan: Continued Data Collection and Follow Up Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer Patient
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 2000
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: Subject with cancer diagnosis

Brief summary: Cancer survivors face unique health challenges as a result of their cancer diagnosis and treatment. OncoLink created an Internet based program for survivors to learn about their risks. A follow up survey will allow us to continue to develop the program in ways that will benefit users. This survey will need to be conducted via email, which will require the collection of the users email address and a secure method of linking the users care plan questionnaire answers to their survey answers.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cancer
* 18 years of age and older

Exclusion Criteria:

* Persons who have never had cancer. This program is designed for survivors of adult cancers.
* Survivors of childhood cancers are referred to the Children's Oncology Group Long Term Follow up Guidelines.

Primary outcomes:
measure: Number of subjects completing questionnaires
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: James Metz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039623: Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference
Official title: Randomized Assessment of Safety and Immunogenicity of Intradermal Unadjuvanted Portion of Pandemrix® Via a Microneedle Device With Intramuscular Adjuvanted Pandemrix® as Reference
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Detailed description: Healthy volunteers will be vaccinated against H1N1 pandemic influenza. One group will receive the adjuvant vaccine while the other group will get intradermal antigen, without the adjuvant. The antibody production will be compared.

Eligibility criteria: Inclusion Criteria:

* Age: 18-64
* Both genders
* Healthy

Exclusion Criteria:

* Under 18 or above 64
* Not healthy

Primary outcomes:
measure: antibody levels
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: