louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01486628: Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Official title: A Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson's Disease
Lead sponsor: NeuroDerm Ltd.
Sponsor class: INDUSTRY
First posted: 2011-12-06
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It will be a single dose, single-center, randomized, double-blind, placebo-controlled dose escalation study of SC continuously-delivered LD/CD solution (ND-0612) for 24 hours in healthy volunteers.

Objectives are to determine:

1. the maximal tolerated dose of SC ND-0612
2. the steady state plasma concentration of LD and CD following SC ND-0612 administration.

Each treatment group will include 6 healthy volunteers. Dosing will be done in a sequential manner.


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasian males between 18 and 40 years (inclusive) of age
* Normal BMI (18.5-24.9)
* Subjects with negative urinary drugs of abuse, HIV, Hepatitis B or Hepatitis C serology tests
* Subjects must be able to adhere to the protocol requirements
* Subjects must provide written informed consent to participate in the study.

Exclusion Criteria:

* History of significant psychiatric disorder, neurological diseases or sleep disorders
* History of significant systemic diseases, by medical history or tests performed during screening examinations
* Clinically significant laboratory tests at screening
* History of drug or alcohol abuse.
* Allergy to levodopa, carbidopa or any inactive component of the test formulation.
* Subjects with dark skin
* Subjects with skin diseases or neoplasms
* Subjects with narrow-angle glaucoma
* Subjects with significant allergic response to other drugs.
* Presence of clinically significant scars or other skin disorders in the area of placement of the pump.
* Use of any prescription or over-the-counter (OTC) medications
* Subjects who donated blood or received blood, in the last 3 months
* Participation in another clinical trial in the last 30 days
* Subjects which do not have the ability to communicate well or will not adhere to the protocol procedures

Primary outcomes:
measure: Safety and tolerability
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00006328: Angiotensin-Converting Enzyme Gene Polymorphism and the Risk of Chronic Allograft Nephropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Disease
Keywords: Chronic Allograft Nephropathy (CAN)
Transplantation immunology
Genetics
Graft Rejection
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-10-05
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: RETROSPECTIVE

Brief summary: This study is intended to help doctors learn about the relationships between specific genetic makeup (gene markers) and the development of chronic rejection. This study is being done to see if there is a relationship between genetic patterns and the development of Chronic Allograft Nephropathy (CAN). Medical scientists also hope to learn more about how genetic differences between people determine their response to a drug or a disease by storing a small blood sample in a special "bank". This sample may be tested at some point in the future in an attempt to better understand the factors that may influence rejection, transplantation outcomes and transplant success rates.


Eligibility criteria: Inclusion Criteria:

* All subjects must be recipients of a renal allograft.
* Study subjects must have evidence of biopsy-proven Chronic Allograft Nephropathy (CAN).
* Control subjects must not have evidence of CAN.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Univ. of Michigan Health System
state: Michigan
Study officials:
References:
Clinical trial NCT04376528: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy
Official title: Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Duo to Nonresponse to Standard Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis, Autoimmune
Primary Biliary Cholangitis
Immunosuppression
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by mycophenolate mofetil versus cyclosporin A


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-70 years;
2. Diagnosed with PBC-AIH overlap syndrome according to Paris criteria;
3. Patients have a nonresponse to azathioprine;
4. The WBC count ≥2.5x10\^9/L and platelet count ≥50x10\^9/L.
5. Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

1. The presence of hepatitis A, B, C, D, or E virus infection;
2. Patients with presence of serious decompensated cirrhosis;
3. Patients have a history of glucocorticoid or immunosuppressant medication before enrollment;
4. Liver damage caused by other reasons: such as primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson's disease.
5. Pregnant and breeding women and women of childbearing age in need of reproduction
6. Severe disorders of other vital organs, such as severe heart failure, cancer;
7. Patients with presence of renal insufficiency;
8. Parenteral administration of blood or blood products within 6 months before screening;
9. Recent treatment with drugs having known liver toxicity;
10. Taken part in other clinic trials within 6 months before enrollment.
11. Patients who are allergic to these drugs;
12. Uncontrolled infection and hypertension ;

Primary outcomes:
measure: Biochemical remission
timeFrame: up to 6 months
Secondary outcomes:
measure: Partial remission
timeFrame: up to 6 months
measure: Minimal response
timeFrame: up to 6 months
measure: Treatment failure
timeFrame: up to 6 months
measure: Changes in liver stiffness
timeFrame: up to 6 months
measure: Side-effects
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: WestChina Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT03519828: Oxidation-reduction Homeostasis in Cognitive Impairment Patients After Stroke
Official title: Effects of Oxidation-reduction Homeostasis on Cognitive Impairment in Patients With Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative-reduction Homeostasis
Post-stroke Cognitive Impairment
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients in hospital from March, 2018 to September, 2018.

Brief summary: Cognitive impairment after ischemic stroke can affect not only the social adaptation ability, but also affect the comprehensive rehabilitation of patients. The damage of cognitive impairment after ischemic stroke is not lower than the body function defect after stroke. Many studies have shown that oxidative stress is one of the pathophysiological mechanisms of ischemic cerebrovascular disease. Many studies have reported that the oxidative-reduction of cells plays an important role in the life activities of organisms, affecting the health, aging and death of the organism. In the recent years, some scholars have suggested that post-stroke cognitive impairment may be related to oxidative-reduction homeostasis of the body, but the relevant evidence is lacking and needs to be further explored. Therefore, the purpose of this study is to explore the effect of oxidation-reduction homeostasis on cognitive impairment in patients with ischemic stroke, and provide a theoretical basis for the prevention and treatment of cognitive impairment after ischemic stroke.


Eligibility criteria: Inclusion Criteria:

* 40-80 years old;
* Ischemic stroke for the first time or previous stroke but with no serious sequelae (mRS is 0 -2 points);
* Time from onset to treatment ≤48 hours;
* Conscious awareness, and with no obvious aphasia and visual impairment;
* Signed informed consent by patient self or legally authorized representatives.

Exclusion Criteria:

* Intracranial hemorrhage or suspected subarachnoid hemorrhage;
* Transient ischemic attack;
* Patients with severe mental disorders or language disorders;
* Patients can not cooperate with evaluators, such as mental illness or dementia;
* Pregnant women or suckers;
* Researchers consider patients inappropriate to participate in the registry.

Primary outcomes:
measure: Oxidative-reduction homeostasis in acute ischemic stroke patients
timeFrame: 1 day
measure: Cognitive function in acute ischemic stroke patients
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of ShenYang Military Region
state: Liaoning
Study officials:
References:
Clinical trial NCT02062528: Hot Flashes and Omega 3
Official title: Evaluation de l'efficacité Des Acides Gras oméga 3 Hautement concentrés en EPA Sur Les bouffées de Chaleur, Chez Des Femmes en période de péri-ménopause et ménopause : étude Monocentrique, en Groupes parallèles, contrôlée, randomisée vs Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Fatty Acids
Menopause
Keywords: EPA
Lead sponsor: Vivatech
Sponsor class: INDUSTRY
Collaborators: name: Centre d'Investigation Clinique de Grenoble CIC1406
First posted: 2014-02-13
Enrollment: 136
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective is to evaluate the effects of omega-3 fatty acids on hot flashes frequency.


Eligibility criteria: Inclusion Criteria:

* menopause or peri menopause
* complaining of hot flashes
* social security affiliation
* informed consent form signed

Exclusion Criteria:

* primary pathology which can lead to hot flashes
* allergy to omega-3 fatty acids
* allergy to sea products
* High consumption of fat fish or produced by the sea
* iatrogenic hot flashes
* actual omega-3 fatty acids consumption or in the 3 last months.
* consumption of drug or other products for hot flashes in the last month
* protected persons (L1121-5 to L1121-8 of French Public health code)

Primary outcomes:
measure: hot flashes frequency
timeFrame: 1 to 8 week
Secondary outcomes:
measure: hot flashes frequency difference
timeFrame: 4 week and 8 week
measure: diurnal hot flashes
timeFrame: week 1 to 8
measure: night hot flashes
timeFrame: week 1 to 8
measure: vasomotors disorders
timeFrame: week 1 to week 8
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: week 0 and week 8
measure: HFRDIS
timeFrame: week 0 and week 8
measure: The Menopause-Specific Quality of Life (MENQOL)
timeFrame: week 0 and week 8
measure: Weight
timeFrame: week 0 and week 8
measure: fatty acids dosage
timeFrame: week 0 and week 8
measure: number of adverse events
timeFrame: week 0 to week 8
Other outcomes:
Locations:
city: GRENOBLE cedex9
country: France
facility: Centre d'investigation clinique CIC1406
Study officials:
affiliation: Centre d'investigation clinique CIC1406
name: Jean-Luc CRACOWSKI, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00973128: Reduced Doses of Antimony Plus Ranulocyte Monocyte Colony Stimulating Factor (GM-CSF) for Cutaneous Leishmaniasis
Official title: Reduced Doses of Antimony Plus Recombinant Human GM-CSF Compared With Antimony in Standard Doses for Cutaneous Leishmaniasis: a Randomized, Single-blind, Placebo-controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Leishmaniasis
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado da Bahia
First posted: 2009-09-09
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study was designed as a randomized, single blind, placebo-controlled, study to evaluate the effect of 400 µg of recombinant human GM-CSF applied intralesionally and associated with half of the total dose of antimony in a reduced time schedule (20mgSbV/Kg/d for 10 days) as compared to the full dose of antimony (20mgSbV/Kg/d for 20 days) to treat cutaneous leishmaniasis ulcers.

Detailed description: This is a randomized, single blind placebo-controlled study in which the groups were selected from the cases presenting to the health post. The inclusion criteria were: age between 15 and 50 years, of either sex, diagnosis of cutaneous leishmaniasis of less than 60 days. The diagnostic criteria were the presence of a typical single cutaneous ulcer, localized on lower limbs, and a positive delayed type hypersensitivity test (DTH or Montenegro skin test) to Leishmania antigen.

Eligibility criteria: Inclusion Criteria:

* Age between 15 and 50 years
* Either gender
* Diagnosis of cutaneous leishmaniasis
* Less than 60 days of disease

Exclusion Criteria:

* Any history of prior anti-leishmania therapy
* Negative parasitology (aspirate/smear)or negative Montenegro test
* Pregnancy
* Age below 15 and above 50 years
* Other associated acute or chronic illnesses
* History of allergy to GM-CSF and/or antimony
* HIV, HTLV-1 infections or diabetes
* Administrative reasons:
* Lack of ability or willingness to give informed consent (patient and/or parent / legal representative)
* Anticipated non-availability for study visits/procedures

Primary outcomes:
measure: Cure rate or complete cicatrization of the ulcer
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Initial cure rate or complete cicatrization of the ulcer.
timeFrame: 2 months after treatment.
Other outcomes:
Locations:
city: Valença
country: Brazil
facility: Health Post of Corte de Pedra
state: Bahia
Study officials:
affiliation: Hospital Universitário Prof Edgard Santos-UFBA
name: Roque P Almeida, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04302428: Zinc Status and Growth in Cystic Fibrosis
Official title: Zinc Status and Growth in Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic
Fibrosis
Keywords: Zinc
Growth
Nutrition
Cystic
Fibrosis
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 35
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients ages 3 months to 3 years with CF identified via new born screening

Brief summary: The purpose of this study is to improve the understanding of the relationship of zinc status and growth in infants and young children who were diagnosed with cystic fibrosis via newborn screening.

Detailed description: The objective of this study is to improve the understanding of the relationship of zinc (Zn) status and growth in infant and young people with cystic fibrosis (PWCF). The investigators hypothesize that Zn deficiency in infant and young PWCF is associated with poor growth.

Aim #2: To study the association between Zn levels in red blood cells and nutritional status in PWCF at 3 months to 3 years of age and compare it to the association between serum Zn and nutritional status in the same population. Hypothesis: Lower Zn levels in red blood cells is associated with poorer nutritional status in infant and young PWCF and is a better measure of Zn status compared to serum Zn.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients ages 3 months to 3 years with CF identified via new born screening

Exclusion Criteria:

* History of meconium ileus
* History of prematurity (born prior to completing 36 weeks 6 days gestation)

Primary outcomes:
measure: Zinc Status
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at Indiana University Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Clement Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05488028: 3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT
Official title: Three-dimensional Facial Swelling Evaluation of Piezo-electric Versus Conventional Drilling Bur Surgery of Impacted Lower Third Molar: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Swelling/ Edema
Impacted Third Molar Tooth
Keywords: piezosurgery
conventional osteotomy
impacted lower third molar
facial scan
3d rendering
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth model
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate the swelling following the osteotomy when performed with drilling bur versus piezo-electric instrument in the mandibular impacted third molar extraction, using a facial reconstruction software


Eligibility criteria: Inclusion Criteria:

* good general health conditions;
* presence of bilateral and symmetrical impacted third molars (according to the classifications of Winter and Pell and Gregory);

Exclusion Criteria:

* no clinical evidence of major facial asymmetry;
* use of medication that would influence or alter wound healing;
* temporomandibular joint disorder history;
* smoking

Primary outcomes:
measure: Facial swelling
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University Hospital Policlinic Gaetano Martino
state: Messina (ME)
Study officials:
References:
Clinical trial NCT05059028: Effect of Oxytocin Massage and Music on Breastfeeding
Official title: Effect of Oxytocin Massage and Music on Breastfeeding: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxytocin
Massage
Music
Breastfeeding
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the effect of oxytocin massage and music performed immediately after birth on breastfeeding.


Eligibility criteria: Inclusion Criteria:

* mothers who are 20 years or older,
* Primiparous delivery,
* Single fetus pregnancy,
* Born at term (38-42 weeks of gestation),
* Your baby's Apgar score is at least 8 points in the 5th minute,
* Being literate,
* Interviewed on the first day after birth,
* Does not have a problem that prevents breastfeeding,
* No complications during and after birth,
* Staying in the same room with her baby after birth,
* There is no health problem that may affect the baby's suckling,
* Those who become pregnant by normal means (without IVF, IVF, etc.),
* Babies with a birth weight of more than 2500,
* Mothers without chronic disease,
* Non-smoking mothers,
* Mothers who do not give formula to their babies

Exclusion Criteria:

* The mother/baby has a serious health problem that prevents breastfeeding,
* Absence from education for at least two sessions,
* Women with a known disease (HIV, hepatitis B, hepatitis C, etc.) known to be transmitted through breast milk will be excluded from the study.

Primary outcomes:
measure: Breastfeeding Diagnostic and Evaluation Scale
timeFrame: 1 month
measure: Breastfeeding Self-Efficacy Scale short form
timeFrame: 1 month
measure: Infant Nutrition Attitude Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
state: Other
Study officials:
References:
Clinical trial NCT02274428: Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Official title: Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Mesenchymal Stromal Cells
Keywords: intraventricular hemorrhage
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-10-24
Enrollment: 9
Sex: ALL
Minimum age (years): 23
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)


Eligibility criteria: Inclusion Criteria:

* 23-34w
* IVH grade 3-4, confirmed with brain ultrasonogram
* within 7 days after IVH diagnosis

Exclusion Criteria:

* severe congenital anomaly
* intrauterine intracranial bleeding
* intracranial infection
* severe congenital infection
* active and uncontrolled infection, CRP\>10mg/dl
* Platelet count \<50,000/ml
* severe metabolic acidosis (PH\<7.1, BE\<-20)

Primary outcomes:
measure: unsuspected death or anaphylactic shock
timeFrame: within 6 h after pneumostem transplantation
Secondary outcomes:
measure: Death or hydrocephalus required shunt operation
timeFrame: First discharge home, maximum time frame : 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Soon Park, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References: