louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00720265: A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
Official title: A PHASE III, Randomized, Open-Label, Comparative, Multi - Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus) and MR4 (Modified Release Tacrolimus) in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Organ Transplantation
Tacrolimus
Prograf
FK506MR
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2008-07-22
Enrollment: 135
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To prove non-inferiority of MR4 to Prograf by evaluating the efficacy and safety of Prograf and MR4 in new kidney transplant recipients


Eligibility criteria: Inclusion Criteria:

* Patient must receive first oral dose of randomized study drug 2days(min 1day) prior to transplant procedure
* Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to enrollment

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient has received a Kidney transplant from non-heart beating donor or a cadaveric donor
* Patients has received an ABO incompatible donor kidney
* Recipient or donor is known to be seropositive for human immunodeficiency virus(HIV)
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully
* Patient has significant liver, disease, defined as having during the past 28 days continuously elevated AST (SGOT) and/or ALT (SGPT) levels greater than 3 times the upper value of the normal range of the investigational site
* Patient has an uncontrolled concomitant infection(including Hepatitis B, Hepatitis C)or any other unstable medical condition that could interfere with the study objectives
* Patient is currently taking or has been taking an immunosuppressive agents in the 30 days prior to transplant(except from two days prior to transplant)
* Patient has a known hypersensitivity to tacrolimus
* Patient is pregnant or lactating

Primary outcomes:
measure: Acute rejection within 24 weeks (6 months)
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of biopsy-proven acute rejection (Banff Grade ≥ 1)
timeFrame: at 6 months
measure: Time to first acute rejection episode
timeFrame: for 6 months
measure: 6 month patient and graft survival rate
timeFrame: at 6 months
measure: Severity of acute rejection
timeFrame: 6 months
measure: Adverse events, laboratory parameters and vital signs
timeFrame: Throughout trial
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Korea, Inc.
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT02094365: A Phase 2a Study to Evaluate ALS-008176 in the Virus Challenge Model
Official title: A Randomised, Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered ALS-008176 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Alios Biopharma Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the antiviral effect of ALS-008176 compared to a placebo control in the respiratory syncytial virus challenge model.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 45 years, inclusive.
* In good health with no history of major medical conditions
* A total body weight ≥ 50 kg and a body mass index (BMI) of \> 18kg/m2.

Exclusion Criteria:

* Acute or chronic medical illness
* Positive for Human Immunodeficiency Virus, Hepatitis B or C
* Nose or nasopharynx abnormalities
* Abnormal lung function

Primary outcomes:
measure: Change in viral load measurements.
timeFrame: Baseline to day 12
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Retroscreen Virology Ltd
Study officials:
affiliation: Retroscreen Virology Ltd.
name: Hosnieh Fathi, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: DeVincenzo JP, McClure MW, Symons JA, Fathi H, Westland C, Chanda S, Lambkin-Williams R, Smith P, Zhang Q, Beigelman L, Blatt LM, Fry J. Activity of Oral ALS-008176 in a Respiratory Syncytial Virus Challenge Study. N Engl J Med. 2015 Nov 19;373(21):2048-58. doi: 10.1056/NEJMoa1413275.
Clinical trial NCT05554965: Endoscopic Hemostatic and Sedative Treatment of Esophageal and Gastric Variceal Bleeding
Official title: Clinical Study of Remazolam Besylate for Sedation During Endoscopic Hemostatic Treatment of Esophageal and Gastric Variceal Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Endoscopic Hemostasis
Sedation
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remazolam besylate was used for sedation during endoscopic hemostasis in patients with esophageal and gastric varices rupture and bleeding in liver cirrhosis. The onset time, recovery time and incidence of adverse reactions were observed.

Detailed description: Esophagogastric variceal bleeding (EGVB) is one of the most serious and common complications of liver cirrhosis. Endoscopic hemostasis is the most widely used and important method for the prevention and treatment of EGVB. The treatment of varicose veins hemostasis under gastroscope has the problem of long operation time. Patients are prone to nausea, vomiting and excessive secretions due to nervousness and fear, which affect endoscopic insertion and observation, leading to failure of ligation and massive bleeding, and even death. Therefore, appropriate analgesic and sedative drugs are necessary to ensure endoscopic treatment and improve the prognosis. Remimazolam, an ultra-short-acting benzodiazepine drug, is obtained by introducing metabolizable methyl propionate side chain into midazolam. It may have a good effect on sedation during endoscopic hemostasis in cirrhotic patients with ruptured esophageal and gastric varices.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with bleeding from ruptured esophageal and gastric varices
* Endoscopic hemostatic treatment was performed
* Body Mass Index(BMI)18～28kg/m2

Exclusion Criteria:

* History or evidence of increased risk of sedation/anesthesia;
* Pregnant and lactating women;
* Have participated in other drug trials within 30 days prior to enrollment;
* those with contraindications to propofol, opioids and their remedies;
* Unwilling to sign informed consent.

Primary outcomes:
measure: Sedation scores
timeFrame: From the begin to 48 hours after procedure
Secondary outcomes:
measure: Rate of adverse events
timeFrame: Within 2 hours from the start of administration to the end of administration
measure: Vital signs
timeFrame: From the begin to 48 hours after procedure
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT05085665: Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Official title: Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Loiasis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Center for Research on Filariasis and Other Tropical Diseases, Cameroon
First posted: 2021-10-20
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.

Detailed description: A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.

Eligibility criteria: Inclusion Criteria:

* Loa loa blood microfilariae of between 5,000 - 18,000 per mL

Exclusion Criteria:

* known allergy to ivermectin; severe comorbidities

Primary outcomes:
measure: Cross-reactive Antigenemia
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
Study officials:
References:
Clinical trial NCT02029365: Transversal, Controlled and Not Randomized Study, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
Official title: Single-center Study, Transversal, Controlled and Not Randomized, Laying on the Desire of Children and Eating Disorders in a Population of Infertile Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Eating Disorders
Keywords: Infertility
desire for children
eating disorder
anorexia nervosa
bulimia nervosa
eating disorders not otherwise specified
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In France , 15% of couples seek help for problems conceiving . In 10% of cases, infertility remains " unexplained" . Among the causes of female infertility , there are the eating disorders, as well as sexual disorders , these two cases may be linked. In addition, data from the literature seem to suggest that beyond a diagnosis of eating disorders, the feeding behavior of infertile women is more often disturbed than the general population. Moreover, the notions of desire for a child and maternal representations seem essential to address in the comprehensive care of women with infertility but also TCA integrating all conflicting issues reactivated at the time of motherhood. However, little work has been done on this subject. Thus, we propose a study on the desire for children and the eating disorders to infertile women, to update epidemiological data, but also to better characterize this particular patient population. Perspectives of this work are to improve screening measures and support through a joint work of doctors reproductive and psychiatrists.


Eligibility criteria: Inclusion Criteria:

* Women
* Major
* In a relationship
* Infertile (WHO criteria)
* Consultant in the Department of infertility (BMDR) for AMP
* Understanding of French, literate
* Agree to participate in the study

Exclusion Criteria:

* Man
* Minor
* Pregnancy at the time of assessment
* Exclusive Infertility spouse
* Disorders of higher functions (severe cognitive impairment or confusion) or psychosis (hallucinations, delusional syndrome)
* Major protected

Primary outcomes:
measure: Children desire
timeFrame: 30 days
Secondary outcomes:
measure: Dysmorphic
timeFrame: 30 days
measure: Sexuality
timeFrame: 30 days
measure: Anxiety and depression
timeFrame: 30 days
measure: Quality of life questionnaire
timeFrame: 30 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes university Hospital
Study officials:
affiliation: Nantes University Hospital
name: Marie GRALL-BRONNEC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02046265: Clinic-based Intervention to Promote Cervical Cancer Prevention Behaviors
Official title: Step up to Prevention : A Nurse Practitioner Guided Cervical Cancer Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer prevention
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project is a clinical behavioral research project based at University of Pennsylvania. The goal of this research is to design a brief clinic-based, Nurse Practitioner-guided, and theory-based health promotion intervention to enhance cervical cancer prevention among young women ages 18-26 living in economically disadvantaged urban communities. The investigators will evaluate the intervention for feasibility, acceptability and preliminary efficacy.


Eligibility criteria: Inclusion Criteria:

* Age 18-26 years
* Not yet received the HPV vaccine
* Speak, read, and understand 5th grade level of English;
* Had vaginal sex with a male partner in the past 2 months.

Exclusion Criteria:

• Currently pregnant and/or plan to be pregnant in next 6 months

Primary outcomes:
measure: Human Papilloma Virus (HPV) Vaccine #1 Acceptance
timeFrame: For each participant, at end of first study visit. Will assess until all subjects enrolled in study.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania, Outpatient Ob/GYN clinic
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Anne M Teitelman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01912365: Splinting Versus Casting for Type I Supracondylar Fractures
Official title: Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Fractures
Keywords: Fracture
Supracondylar
Pediatric
Orthopedic
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-07-31
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible participants will be recruited from the Emergency Department at BC Children's Hospital

Brief summary: Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.


Eligibility criteria: Inclusion Criteria:

* Ages 3-12
* Type 1 supracondylar fracture

Exclusion Criteria:

* A type 2 or 3 supracondylar fracture
* Neurovascular compromise associated with the fracture
* Previous diagnosis with a metabolic or structural bone disease
* Other fractures to ipsilateral upper extremity
* History of injury to affected elbow

Primary outcomes:
measure: Baumann's Angle
timeFrame: 6 Months
Secondary outcomes:
measure: Humero-Capitellar Angle
timeFrame: 6 Months
measure: Functional Outcome Questionnaire
timeFrame: 6 Months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri, MBBS, MS, MHSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06644365: Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms
Official title: Examining the Effect of Acupressure Mat on Perceived Stress, Sleep Quality and Premenstrual Symptoms in Students Experiencing Premenstrual Syndrome: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Premenstrual Symptoms
Effect of Acupressure Mat
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose of the study: To examine the effect of acupressure mat on perceived stress, sleep quality and premenstrual symptoms in students with premenstrual syndrome.

Hypotheses of the study;

In the post-test and follow-up test between students who were applied acupressure mat and those who were applied plain mat;

H10: There is no difference in terms of severity of premenstrual symptoms.

H20: There is no difference in terms of perceived stress.

H30: There is no difference in terms of sleep quality.


Eligibility criteria: Inclusion Criteria:

* Using medication and/or non-medical methods to cope with PMS
* Having any gynecological disease (abnormal uterine bleeding, myoma, ovarian cyst, etc.)
* Using contraceptive medication.

Exclusion Criteria:

* Participants wanting to withdraw from the study at any stage of the study
* Participants not complying with the research plan
* Diagnosed with a psychiatric or gynecological disease during the study
* Participants starting to receive additional treatment for PMS during the study period

Primary outcomes:
measure: Premenstrual Syndrome Symptom Scale
timeFrame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
measure: Perceived Stress Scale
timeFrame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
measure: Visual Analog Scale (VAS) Sleep Quality
timeFrame: just before the application starts (pre-test), 12 weeks after the application starts (after the application ends/post-test) and 16 weeks later (follow-up test).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06236165: Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
Official title: Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatic and Post Hepatic Jaundice
Keywords: Jaundice
N-acetylcysteine
TAC
TNF-α
Bilirubin
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 44
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: Investigating the efficacy, safety, and molecular mechanism of N-acetylcysteine supplementation in improving elevated direct bilirubin level and liver function tests in patients with hepatic and post-hepatic jaundice.


Eligibility criteria: Inclusion Criteria:

* Patients age 18-70 years old.
* Patients diagnosed with jaundice and increased level direct bilirubin ≥ 3 mg/dL.

Exclusion Criteria:

* Pregnancy.
* Nursing mothers.
* Patients with increased indirect bilirubin level.
* Patients who have Gilbert syndrome or Crigler Najjar syndrome.
* Patients with Child Paugh C score (10-15 point).
* History of known hypersensitivity to N-acetylcysteine.

Primary outcomes:
measure: Change in total antioxidant capacity (TAC) level
timeFrame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
measure: Change in tumor necrosis factor alpha (TNF-α)
timeFrame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Secondary outcomes:
measure: Adverse events and toxicity
timeFrame: 3 months.
measure: Follow up of liver function
timeFrame: The participants will be assessed before initiation of the study (baseline), and at the end of the study after 3 months.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Pharmacy, Tanta University
Study officials:
affiliation: Tanta University
name: Samah Hussein
role: PRINCIPAL_INVESTIGATOR
References: