louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04320225: Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia
Official title: A Prospective Observational Study: Connection Between Vitamin D Level and the Efficacy of Dexamethasone in Immune Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Thrombocytopenia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed ITP patients

Brief summary: The project was undertaking by Qilu Hospital of Shandong University in China. The objective is to find out if there is a connection between vitamin D level and the efficacy of dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Detailed description: The investigators anticipate to undertaking a prospective, observational，non-randomized control trial of 60 ITP adult patients. Dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days) will be used in the target patients. Vitamin D level will be detected before the utilization of treatment measures. Depend on the vitamin D level, the patients will be divided into 2 groups(higher vitamin D level group and lower vitamin D level group).Platelet count, bleeding and other symptoms were evaluated before and after treatment.

Eligibility criteria: Inclusion Criteria:

Corresponding to the diagnostic criteria for immune thrombocytopenia Newly diagnosed ITP patients To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations Willing and able to sign written informed consent

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test; Patients who are deemed unsuitable for the study by the investigator.

Primary outcomes:
measure: Sustained response to ITP treatments
timeFrame: 3 months after treatment started
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06175325: Trans-radial Superior Rectal Artery Embolisation for Haemorrhoids
Official title: Pilot Study of the Safety and Efficacy of Trans-radial Superior Rectal Artery Embolisation for the Treatment of Haemorrhoids
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Keywords: Embolisation
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2023-12-18
Enrollment: 20
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: Endovascular embolisation is already a common procedure for bleeding haemorrhoids in the acute setting, where surgical options are not possible or have been exhausted. This pilot study aims to add to the small body of evidence that transarterial embolisation of symptomatic haemorrhoids is also safe and effective in the elective setting, providing a good alternative to conventional surgical management. This is a day case procedure that is performed under local anaesthetic. For selected patients, this presents a less invasive management option with reduced potential morbidity. For a health care system under significant financial stress, this provides a potential means of cost improvement, the extent of which this study will try and quantify. A series of 20 selected patients will be recruited to undergo this procedure and then followed up for 24 months. The long-term goal of this pilot study is to form the basis of a national registry of such procedures.


Eligibility criteria: Inclusion Criteria:

Patients eligible for the study must comply with all of the following prior to enrolment:

* Patients with grade II-IV haemorrhoid disease with re-current or active bleeding
* Patients with (i) who do not wish to undergo surgery for their symptoms
* Patients with (i) despite recent surgery
* Patients willing and able to give fully informed consent
* Patients aged ≥18 years

Exclusion Criteria:

* Patients who are not otherwise fit for surgery
* Patients with significant ano-rectal comorbidities (cancer, fistula, abscesses)
* Patient who are unable to sign the informed consent form.
* Patients who are pregnant (completed as part of standard IRMER protocol)
* Patients with history of significant colorectal disease or previous colectomy.
* Patients with history of an allergic reaction to x-ray contrast
* Patients who are currently involved in research

Primary outcomes:
measure: Safety and long-term effects
timeFrame: 3 years
Secondary outcomes:
measure: Change of symptoms
timeFrame: 3 months
measure: Change of symptoms
timeFrame: 12 months
measure: Change of symptoms
timeFrame: 24 months
measure: Cost comparison
timeFrame: 3 years
measure: Procedural times comparison
timeFrame: 3 years
measure: Radiation dose comparison
timeFrame: 3 years
measure: Contrast volume comparison
timeFrame: 3 years
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References:
Clinical trial NCT00894725: Laparoscopic Versus Open Left Colonic Resection
Official title: Laparoscopic vs. Open Left Colonic Resection: a Randomized Monocentric Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colon Cancer
Benign Disease
Keywords: left colon cancer
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2009-05-07
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main goal of this study is to clarify if laparoscopy (LPS) could become the standard approach in patients undergoing left colonic resection.

268 patient candidates to left colonic resection were randomly assigned to LPS (n=134) or open (n=134) approach. Postoperative care protocol was the same in both groups. Trained members of the surgical staff who were not involved in the study registered 30-day postoperative morbidity. Cost-benefit analysis was based on hospital costs. Long-term morbidity, quality of life, and 5-year survival have also been evaluated.

Detailed description: The study design was explained to the potential participants who were asked to sign a written informed consent before randomization.

Eligible patients were randomly allocated to LPS or open surgery. Randomization list was computer generated. Assignments were made by means of sealed sequenced masked envelopes which were opened, before the induction of anesthesia, by a nurse unaware of the trial design.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* suitability to elective surgery

Exclusion Criteria:

* cancer infiltrating adjacent organs assessed by computed tomography
* cardiovascular dysfunction (New York Heart Association class \> 3)
* respiratory dysfunction (arterial pO2 \< 70 mmHg)
* hepatic dysfunction (Child-Pugh class C)
* ongoing infection
* plasma neutrophil level \< 2.0x109/L

Primary outcomes:
measure: short-term morbidity rate
timeFrame: 30 days
Secondary outcomes:
measure: long-term outcome
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital, Surgical Department
Study officials:
affiliation: San Raffaele Vita-Salute University
name: Marco Braga, MD
role: STUDY_DIRECTOR
References:
citation: Braga M, Frasson M, Zuliani W, Vignali A, Pecorelli N, Di Carlo V. Randomized clinical trial of laparoscopic versus open left colonic resection. Br J Surg. 2010 Aug;97(8):1180-6. doi: 10.1002/bjs.7094.
Clinical trial NCT03869125: Masked Hypertension in Patients With Obstructive Sleep Apnoea
Official title: Masked Hypertension Evaluated by Automated Office Blood Pressure Measurement (AOBPM) and Office Blood Pressure Measurement (OBPM) in Patients With Obstructive Sleep Apnoea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 65
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: Patients with suspected obstructive sleep apnoea syndrome

Brief summary: Assessment of the possible difference in masked hypertension prevalence when it is evaluated by automated office blood pressure measurement (AOBPM) instead of office blood pressure measurement (OBPM) in patients with obstructive sleep apnoea.

Detailed description: Rationale:

Obstructive sleep apnoea is characterized by repetitive closure of upper airways leading to apnoea (complete airflow cessation) or hypopnoea (airflow limitation \> 50%+ blood oxygen desaturation \> 4%). It is considered to be an important risk factor for arterial hypertension. In these patients is highly prevalent nocturnal hypertension (NH) and also masked hypertension (MH). Ambulatory blood pressure monitoring (ABPM) is considered to be a gold standard for the diagnosis of NH and MH. Results of ABPM are compared with office blood pressure measurement which could be falsely elevated in some patients (white coat effect). For this reason, automatic office blood pressure measurement was developed. Nowadays some devices like BpTRU were developed. This was validated on some patient groups but robust data for patients with obstructive sleep apnoea are missing.

Process:

Patient with ronchopathy and suspected obstructive sleep apnoea undergo automated office blood pressure monitoring followed by office blood pressure monitoring at the Department of Exercise Medicine and Cardiovascular Rehabilitation. After education, ambulatory blood pressure monitor will be provided to patients for the following 24 hours. In the same night, respiratory polygraphy will be performed in the Sleep Laboratory, Department of Respiratory Medicine, University Hospital Olomouc. All data will be statistically evaluated after completion of the target number of subjects. Patients without obstructive sleep apnoea (apnoea-hypopnoea index \< 5) will not be included in statistical evaluations.

Eligibility criteria: Inclusion Criteria:

* Obstructive sleep apnoea syndrome

Exclusion Criteria:

* Non- compliance of patients with blood pressure monitoring

Primary outcomes:
measure: The difference in masked hypertension prevalence between definition I and definition II
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
Study officials:
affiliation: University Hospital Olomouc
name: Milan Sova, MD.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03246425: Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study
Official title: Influence of Mechanical Ventilation Mode on Arterial Pressure Variations- a Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Pressure
Critical Illness
Hypovolemia
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Mechanical ventilation has been known to produce changes in the flow of blood through the major blood vessels in the body. These changes may go undetected, but with continuous arterial blood pressure measurements, changes in the arterial waveform can be visualized. Although we know that these arterial pressure variations occur during mechanical ventilation, little is known about the effects of various modes of mechanical ventilation on these changes. The most common modes of ventilation used in ICU are Volume control, Pressure control and Airway pressure release ventilation.

Objective We have designed a prospective randomized pilot study to determine the effects of the commonly used ventilator modes on the arterial pressure.


Eligibility criteria: Inclusion Criteria:

Patients 18 yrs of age and older, Patients on mechanical ventilation, Patients deeply sedated in the ICU with RASS scores of atleast -3, Patients having an A-line for blood pressure monitoring, Patients with stable hemodynamics.

Exclusion Criteria:

Patients with moderate-severe ARDS, Patients requiring high inspiratory oxygen requirements, High peak inspiratory pressures requirement for ventilation, Presence of arrhythmia, Patients with spontaneous breathing activity, Patients on weaning mode, Patients having CHF or Cor pulmonale.

Primary outcomes:
measure: The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Stroke Volume Variation.
timeFrame: For 12 months
measure: The study is to compare the effects of different modes of mechanical ventilation on arterial pressure variations. The arterial pressure variations will be measured as changes in the Pulse Pressure Variation
timeFrame: 12 Months
Secondary outcomes:
measure: Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Pulse Pressure Variation
timeFrame: For 12 months
measure: Secondary outcome measured will be the influence of Airway Pressure Release Ventialtion (APRV) on arterial pressure measured using Stroke Volume variation.
timeFrame: 12 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
Study officials:
affiliation: State University of New York - Upstate Medical University
name: Carlos J Lopez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821925: Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes
Official title: Estimation of Osteoporosis' Prevalence in France: Pilot Study in the Department of the Alpes-Maritimes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 800
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to estimate Osteoporosis' prevalence in France and is a pilot study in the Department of the Alpes-Maritimes.


Eligibility criteria: Inclusion Criteria:

* Patient member of Caisse Primaire d'Assurance Maladie

Exclusion Criteria:

* Patient incapable of understanding the questionary

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of Rheumatology
Study officials:
affiliation: Department of Rheumatology
name: Liana Euller-Ziegler, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04573725: Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder
Official title: Early Phase 2 Clinical Study of TS-142 in Patients with Insomnia Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insomnia Disorder
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.


Eligibility criteria: Inclusion Criteria:

* Outpatients
* Patients diagnosed with insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Patients who scored 15 or higher on the Insomnia Severity Index (ISI) at Visit 1
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Patients with a history of any of the following diseases according to the DSM-5 criteria:

  1. Hypersomnolence disorder
  2. Narcolepsy
  3. Breathing-related sleep disorders
  4. Circadian rhythm sleep-wake disorder
  5. Parasomnias
  6. Restless legs syndrome
  7. Substance/medication-induced sleep disorder
* Patients complicated with organic brain disease (including neurodegenerative disease, cerebrovascular disorder), and/or epilepsy
* Patients with a history of poorly controlled diabetes mellitus (HbA1c \>8%)
* Patients with difficulty in sleeping due to medical problems such as pain, pruritus, heart disease, nocturia (\>3 times per night), bronchial asthma, reflux oesophagitis, endocrine disease, hot flush, and periodic limb movement disorder
* Other protocol defined exclusion criteria could apply

Primary outcomes:
measure: LS mean difference of LPS from placebo
timeFrame: Day 1
measure: LS mean difference of WASO from placebo
timeFrame: Day 1
Secondary outcomes:
measure: LS mean difference of TST from placebo
timeFrame: Day 1
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Toshiro Heya
role: STUDY_DIRECTOR
References:
citation: Uchiyama M, Kambe D, Imadera Y, Kajiyama Y, Ogo H, Uchimura N. Effects of TS-142, a novel dual orexin receptor antagonist, on sleep in patients with insomnia: a randomized, double-blind, placebo-controlled phase 2 study. Psychopharmacology (Berl). 2022 Jul;239(7):2143-2154. doi: 10.1007/s00213-022-06089-6. Epub 2022 Mar 17.
Clinical trial NCT05264025: Fexofenadine in Patients With Active Rheumatoid Arthritis
Official title: Fexofenadine as Adjunct to Standard Rheumatoid Therapy in Patients With Active Rheumatoid
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is an inflammatory autoimmune polyarthritis affecting ∼1% of the world population, resulting in the loss of joint function and progressive structural damage in affected joints. Fexofenadine has been widely used to treat various allergic diseases, like allergic rhinitis, conjunctivitis and chronic idiopathic urticaria. the molecular mechanisms underlying fexofenadine mediated inhibition of TNF-α signalling


Eligibility criteria: Inclusion Criteria

* Moderate to severe RA (disease activity score-28 joints: DAS-28 \> 3.2) were recruited.
* Age between 18 - 60 years having active disease according to the diagnosis of an experienced rheumatologist, being under treatment with disease-modifying anti-rheumatic drugs (DMARDs), not receiving cytokine inhibitors
* Signing informed consent and willingness of the participant to accept randomization to any assigned treatment arm.

Exclusion Criteria:

* History of biological DMARDS.
* History/presence of acute heart disease, liver and kidney diseases, COPD
* Intolerance or allergy to fexofenadine or methotrexate
* Alcohol abuse
* Any changes in using medication (changing the dosage or type of medicines
* Receive hormone replacement therapy, warfarin, and other anticoagulants

Primary outcomes:
measure: ACR 20%
timeFrame: at baseline
measure: ACR 20%
timeFrame: at week 12
measure: (HAQDI)
timeFrame: at baseline
measure: (HAQDI)
timeFrame: at week 12
measure: CRP
timeFrame: at baseline
measure: CRP
timeFrame: at week 12
Secondary outcomes:
measure: TNF-α
timeFrame: at baseline and at week 12
measure: NF-κB
timeFrame: at baseline and at week 12
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef Hospital
city: Banī Suwayf
country: Egypt
facility: Faculty of Medicine - Beni Suef Hospital
Study officials:
References:
Clinical trial NCT00707525: Embryo Aneuploidies and Ovarian Stimulation
Official title: Incidence of EmbyoO Aneuploidies in Natural Versus Stimulated Cycles in the Same Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Embryo Aneuploidies
Keywords: aneuploidies, natural cycle, stimulated cycle, preimplantation genetic diagnosis
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2008-07-01
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There is a considerable concern about the effects of controlled ovarian hyperstimulation (COH) for In Vitro Fertilization- Embryo Transfer (IVF-ET) on embryo quality and on the incidence of chromosomal abnormalities in oocytes and embryos.

The main question remaining is if COH may increase the aneuploidies rate in young and healthy women. Therefore, the primary endpoint of the present study is to analyse the incidence of chromosomal abnormalities in this group of patients (oocyte donors), either in oocytes obtained after a natural cycle or in those retrieved after a COH cycle. To get rid of the male factor influence, donated sperm will be used.


Eligibility criteria: Donor Inclusion Criteria:

* 18 to 35 years old.
* BMI: 18-25Kg/m2
* Regular menstrual cycles
* Normal kariotype
* No previous controlled ovarian hyperstimulation (COH) treatments.

Donor Exclusion Criteria:

* Endometriosis
* Policystic ovarian syndrome
* Recurrent miscarriages.

Recipient Inclusion Criteria

* Aged until 45 years old
* No systemic diseases
* Following egg and sperm donation treatment.

Recipient exclusion criteria:

* Uterine disease (polyps, myomas, mullerian defects)
* Recurrent miscarriages.

Primary outcomes:
measure: Embryo aneuploidies
timeFrame: 2 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad
Study officials:
References:
citation: Labarta E, Bosch E, Alama P, Rubio C, Rodrigo L, Pellicer A. Moderate ovarian stimulation does not increase the incidence of human embryo chromosomal abnormalities in in vitro fertilization cycles. J Clin Endocrinol Metab. 2012 Oct;97(10):E1987-94. doi: 10.1210/jc.2012-1738. Epub 2012 Aug 3.