louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002143: Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Official title: Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Psoriasis
Keywords: Psoriasis
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Acitretin
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients.

Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in treating psoriasis in patients without HIV infection by reducing skin involvement and clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.

Detailed description: Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in treating psoriasis in patients without HIV infection by reducing skin involvement and clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.

Patients receive acitretin daily, with dose increases every 4 weeks based on quantitative assessment of the skin using the Psoriasis Area and Severity Index (PASI). Treatment continues for a total of 20 weeks. Patients are followed every 2 weeks.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Any nondermatologic medication.

Patients must have:

* HIV infection.
* Psoriasis involving at least 10 percent of body surface.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Israel Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT02375243: Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
Official title: Use of Dexmedetomidine in Children Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Deep Sedation
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy of dexmedetomidine in reducing the need for sedatives and analgesics in the immediate post-operative period in children who underwent surgical correction of complex congenital heart disease

Detailed description: The hypothesis the investigators want to verify is that the reduced administration of sedative drugs (opioids and benzodiazepines) in children undergoing cardiac surgery, reduces the side effects of the drugs themselves, such as respiratory depression (reduction of mechanical ventilation) and the onset of withdrawal symptoms while maintaining an adequate analgo-sedation.

The study is an unblinded randomized controlled study. It will involve 60 children aged \> 1 and \< 24 months sedated and mechanically ventilated after corrective or palliative surgery of congenital heart disease on cardiopulmonary bypass with Aristotle score \> 8.

Dexmedetomidine infusion will be started upon arrival in the CICU and continued until the time of discontinuation of morphine.

Eligibility criteria: Inclusion Criteria: age \< 24 months but \> 30 days, Aristotle score \>8, elective procedures in cardiopulmonary bypass -

Exclusion Criteria: atrioventricular block prior to the start of infusion; vasoactive inotropic score on arrival to the CICU\>30; brain malformations orbone, muscle or neuromuscolar disease; pleural effusion or pneumothorax prior to the study; hepatic or renal failure

-

Primary outcomes:
measure: mechanical ventilation time
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
Secondary outcomes:
measure: analgo-sedation level
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: withdrawal symptoms
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
measure: safety of dexmedetomidine infusion as a measure of systemic pressure decrease
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 5 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Children's Hospital
Study officials:
affiliation: Bambino Gesù Children Hospital
name: Paola Cogo, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01055743: The Effect of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
Official title: A Randomized, Controlled Trial of Fluorouracil Implants Regional Chemotherapy During the Surgical Treatment for Early Stage Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Early Stage Hepatocellular Carcinoma
Keywords: Fluorouracil Implants
Hepatocellular carcinoma
Radical resection
Lead sponsor: Simcere Pharmaceutical Co., Ltd
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
First posted: 2010-01-26
Enrollment: 250
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 will assess the clinical efficacy and safety of fluorouracil implants regional chemotherapy during the surgical treatment for early-stage hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of stage I hepatocellular carcinoma
* Child-Pugh class A, B
* Radical resection is feasible
* Patients with adequate renal, hepatic, and hematologic function
* Written informed consent

Exclusion Criteria:

* Allergic to chemotherapy drugs
* No measurable lesion
* Receive chemotherapy, radiotherapy or biotherapy within 30 days prior to enrollment
* Evidence of serious infection
* Renal or hepatic dysfunction, significant cardiovascular disease
* Pregnant or lactating women

Primary outcomes:
measure: To assess the clinical benefit of fluorouracil implants regional chemotherapy during the radical resection in early stage hepatocellular carcinoma patients. The primary endpoint is disease-free survival (DFS).
timeFrame: 1, 2, and 3 years
Secondary outcomes:
measure: Quality of Life
timeFrame: from baseline to the last visit
measure: Incidence Rate of Complications
timeFrame: 1, 2, and 3 years
measure: Adverse Events
timeFrame: from the beginning of treatment to the end of study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Shuqun Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725543: Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)
Official title: Remicade Therapy in Ankylosing Spondylitis: Investigation of Real Life Regimen in Austria Over 9 Consecutive Infusions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylitis, Ankylosing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Centocor, Inc.
First posted: 2008-07-30
Enrollment: 358
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with AS will receive Remicade induction therapy at specialized centers.

Brief summary: This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).

Detailed description: This study population was chosen from a non-probability sample.

Eligibility criteria: Inclusion Criteria:

* Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.

Exclusion Criteria:

* Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
* Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
* Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.

Primary outcomes:
measure: Mean Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
timeFrame: Maximum of 24 months
measure: Median Time Interval Between Remicade Infusions in Participants During Maintenance Treatment Following Induction Therapy
timeFrame: Maximum of 24 months
measure: Mean Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
timeFrame: Maximum of 24 months.
measure: Median Dose of Remicade in Participants Receiving Induction Therapy and Subsequent Maintenance Therapy
timeFrame: Maximum of 24 months.
measure: Mean Remicade Dose Per Participant
timeFrame: Maximum of 24 months
measure: Median Remicade Dose Per Participant
timeFrame: Maximum of 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03550443: A Phase 3 Study of Bardoxolone Methyl in Patients With Diabetic Kidney Disease; AYAME Study
Official title: RTA 402 Phase 3 Clinical Trial (A Randomized, Double-blind, Placebo-controlled Clinical Trial in Patients With Diabetic Kidney Disease)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetic Kidney Disease
Keywords: Bardoxolone Methyl
Diabetic Kidney Disease
Diabetes Mellitus
Kidney Diseases
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 1323
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized double-blinded part followed by open label extension part.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the efficacy of multiple oral doses of RTA 402 (5, 10, or 15 mg) administered once daily in patients with diabetic kidney disease (DKD) using the time to onset of a ≥ 30% decrease in estimated glomerular filtration rate calculated from serum creatinine (eGFR) from baseline or end-stage renal disease (ESRD) as an indicator in a randomized, double-blind, placebo-controlled study; the safety of RTA 402 will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with DKD
* Mean eGFR ≥ 15 and \< 60 mL/min/1.73 m²
* Albumin/creatinine ratio (ACR) ≤ 3500 mg/g Cr
* Treatment with an angiotensin converting enzyme (ACE) inhibitor and/or an angiotensin II receptor blocker (ARB) with no change in dosage or medication etc.

Exclusion Criteria:

* Diabetes mellitus that is neither type 1 nor type 2
* Decreased renal function mainly attributed to a non-diabetic cause
* History of renal transplantation or upcoming preemptive renal transplantation
* Confirmed mean systolic blood pressure \> 160 mmHg or a confirmed mean diastolic blood pressure \> 90 mmHg during the 8-week period before screening
* Hemoglobin A1c level \> 10.0% during screening
* Serum albumin level ≤ 3.0 g/dL during screening
* Cardiovascular disease specified in the study protocol
* History of cardiac failure
* BNP level \> 200 pg/mL during screening etc.

Primary outcomes:
measure: Time to onset of a ≥ 30% decrease in eGFR from baseline or ESRD
timeFrame: Through double-blind part completion, approximately 3 to 4 years
Secondary outcomes:
measure: Time to onset of a ≥ 40% decrease in eGFR from baseline or ESRD
timeFrame: Through double-blind part completion, approximately 3 to 4 years
measure: Time to onset of a ≥ 53% decrease in eGFR from baseline or ESRD
timeFrame: Through double-blind part completion, approximately 3 to 4 years
measure: Time to onset of ESRD
timeFrame: Through double-blind part completion, approximately 3 to 4 years
measure: Change in eGFR from baseline at each evaluation time point
timeFrame: Through double-blind part completion, approximately 3 to 4 years
Other outcomes:
Locations:
city: Sendai
country: Japan
facility: Japan Community Health care Organization Sendai Hospital
state: Miyagi
Study officials:
References:
Clinical trial NCT06947343: Effect of Action Observation Therapy in Comparison to Motor Relearning Program on Balance and Mobility Among Subacute Stroke Patients
Official title: Effect of Action Observation Therapy in Comparison to Motor Relearning Program on Balance and Mobility Among Subacute Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacute Stroke
Cerebral Stroke
Cerebrovascular Stroke
Posture
Functional Performance
Keywords: Action observation therapy
Motor relearning program
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized controlled trial. The purpose of this study is to determine the effect of Action Observation Therapy in Comparison to a Motor Relearning Program on Balance and Mobility among subacute stroke patients.

Detailed description: Action observation therapy has proven its positive effects in improving functional performance in stroke patients compared to other neurological and musculoskeletal conditions motor relearning program is also very effective in improving functional performance in stroke patients but previous studies have shown individual effects of AOT and MRP but there is no comparison of AOT with MRP on balance and mobility.

as a result, this study aims to contribute new data to the sparse literature on subacute stroke patients.

The research finidings could provide valuable insights into potential benefits, encouraging evidence-based practices.

Eligibility criteria: Inclusion Criteria:

* Both genders, male and female
* Ischemic stroke patients
* Age 45 years and above
* MMSE\>24
* Able to stand independently for 1 minute
* Patient can maintain starting sitting static position for 10 seconds without arm rest

Exclusion Criteria:

* Any other neurological disorder
* Orthopedic conditions(fracture) affecting balance and mobility
* Visual or auditory impairments

Primary outcomes:
measure: Balance
timeFrame: 8 weeks
measure: anticipatory balance
timeFrame: 8 weeks
measure: Mobility
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
Study officials:
References:
Clinical trial NCT03003143: Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients
Official title: Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients - A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Autoimmune Encephalopathy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation of efficacy of vigabatrin in refractory autoimmune encephalitis patients


Eligibility criteria: Inclusion Criteria:

* Age 18-85
* Possible autoimmune encephalitis
* Patients who have been diagnosed and treated for encephalitis for more than 4 weeks
* Patients with epilepsy (EEG finding or clinically)

Exclusion Criteria:

* septic shock, fever \>38.5 ℃, O2 saturation \<90%, respiratory rate \>25, HR \>120
* previously, mRS=3 or mRS\>3
* MMSE\<20
* Patients who have terminal disease
* eye problem
* pregnancy

Primary outcomes:
measure: Seizure frequency reduction
timeFrame: 3 month of vigabatrin administration
Secondary outcomes:
measure: Modified Rankin Scale
timeFrame: 3 month of vigabatrin administration
measure: Quality of life (Quality of Life in Epilepsy Inventory, QOLIE-31)
timeFrame: after 3 month of vigabatrin administration
measure: Depression (Beck Depression Inventory®-II)
timeFrame: 3 month of vigabatrin administration
measure: Cognition (Mini-Mental State Examination-Korean)
timeFrame: 3 month of vigabatrin administration
measure: Sleep quality (Pittsburgh Sleep Quality Assessment)
timeFrame: 3 month of vigabatrin administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KON CHU, MD, PhD
role: STUDY_CHAIR
References:
citation: Bjurstom H, Wang J, Ericsson I, Bengtsson M, Liu Y, Kumar-Mendu S, Issazadeh-Navikas S, Birnir B. GABA, a natural immunomodulator of T lymphocytes. J Neuroimmunol. 2008 Dec 15;205(1-2):44-50. doi: 10.1016/j.jneuroim.2008.08.017. Epub 2008 Oct 26.
citation: Rossi S, Muzio L, De Chiara V, Grasselli G, Musella A, Musumeci G, Mandolesi G, De Ceglia R, Maida S, Biffi E, Pedrocchi A, Menegon A, Bernardi G, Furlan R, Martino G, Centonze D. Impaired striatal GABA transmission in experimental autoimmune encephalomyelitis. Brain Behav Immun. 2011 Jul;25(5):947-56. doi: 10.1016/j.bbi.2010.10.004. Epub 2010 Oct 20.
Clinical trial NCT06593743: The Safety and Dose Response to Single Anal Doses of NRL001
Official title: Proof of Concept Study in Healthy Volunteers to Investigate the Safety and Dose Response to a Single Dose (0.3%,1% or 3%) of Methoxamine (NRL001)applied to the Anus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Faecal Incontinence
Lead sponsor: Norgine
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.

Detailed description: This is a single centre dose-finding and proof-of-concept study in healthy volunteers to assess the effects of single doses of NRL001 on the mean anal resting pressure (MARP). In addition, the pharmacokinetics of NRL001 and subject safety are also examined.

The study consists of four parts, which evaluate different NRL001 concentrations and sites of application. Treatments consist of a single local application of either 0.3%, 1% or 3% w/w NRL001 gel applied peri-anally, of either 1% or 3% w/w NRL001 gel applied intra-anally, or 1% w/w NRL001 administered rectally. In addition, a 10 mg NRL001-containing suppository applied to the rectum is assessed.

Eligibility criteria: Inclusion Criteria:

* No previous history of ano-rectal conditions/diseases.
* No history of heart disease.
* 18 to 75 years of age.
* Males and females but pre-menopausal females of child bearing potential must be using adequate contraceptive methods and have a negative pregnancy test before the start of the study.

Exclusion Criteria:

* Use of medication in the last 30 days with vasodilatory activity.
* Use of any medication in the last 30 days applied to the anus and/or via the rectum (exception: participation in Part A, Part B or Part C of NRL001-01/2002(HV)
* Regular intake of more than 21 units of alcohol per week.
* Pregnant females.
* Breast feeding mothers.
* Presence of concomitant gastrointestinal diseases or disorders, such as significant abdominal symptoms and haemorrhoids but also any significant organ (e.g. renal, hepatic or cardiac)dysfunction.
* Volunteers whom the investigator feels would not be compliant with the requirements of the trial.

Primary outcomes:
measure: Mean anal resting pressure
timeFrame: Six hours at visit 2
Secondary outcomes:
measure: Blood pressure (mmHg)
timeFrame: Six hours at visit 2
measure: Pulse rate (beats per minute)
timeFrame: Six hours at visit 2
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University Hospital - Queens Medical Centre
Study officials:
affiliation: Norgine
name: Hans-Jürgen Gruss, MD
role: STUDY_DIRECTOR
affiliation: University Hospital - Queens Medical Centre
name: John H Scholefield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04754243: New Protocol in Unexplained Infertility
Official title: A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Unexplained Infertility
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 parallel groups each is receiving different intervention
Primary purpose: TREATMENT

Brief summary: The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

Detailed description: Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs.

Before trying ICSI, we could help these patients with ANTIUI

Eligibility criteria: Inclusion Criteria:

* Unexplained infertility
* Duration less than 5 years
* Good ovarian reserve AMH\> 1.1
* Normal patent tubes
* No previous trials of IUI with the same protocol

Exclusion Criteria:

* Age \> 35 years
* Duration of infertility\> 5 years
* Abnormal semen
* Hypoplastic tubes
* prior failed ICSI

Primary outcomes:
measure: Ovulation
timeFrame: 6 months
measure: Pregnancy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Gharbia
Study officials:
References: