louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966368: Comparison of Two NN1250 Formulations in Healthy Volunteers
Official title: A Trial to Test for Bioequivalence Between Two NN1250 Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in North America. The aim of this clinical trial was to investigate if two formulations of NN1250 (insulin degludec) have the same level of drug exposure to the body.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and ECG (electrocardiogram), as judged by the Investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the Insulin Degludec concentration-time curve from 0 to 120 hours after single dose
timeFrame: From 0 to 120 hours after dosing
measure: Maximum observed Insulin Degludec concentration after single dose
timeFrame: From 0 to 120 hours after dosing
Secondary outcomes:
measure: Time to maximum observed Insulin Degludec concentration after single dose
timeFrame: From 0 to 120 hours after dosing
measure: Area under the Insulin Degludec concentration-time curve from 0 to 24 hours after single dose
timeFrame: From 0-24 hours after dosing
measure: Terminal half-life for Insulin Degludec
timeFrame: From 0 to 120 hours after dosing
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06313268: Safety of Effivia®, a Bevacizumab Biosimilar
Official title: Post-marketing Safety of Effivia®, a Bevacizumab Biosimilar: Phase IV, Observational, Multicenter Clinical Study in Mexican Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Metastatic Cervical Cancer
Non Squamous Non Small Cell Lung Cancer
Lead sponsor: Laboratorios Liomont
Sponsor class: INDUSTRY
Collaborators: name: Servicios Especializados en Ensayos Clínicos, S.C.
First posted: 2024-03-15
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Naive to bevacizumab, adult patients with metastatic colorectal cancer, metastatic cervical cancer, non-squamous non-small cell lung cancer, and other cancer types where Bevacizumab therapy is indicated.

Brief summary: This is a post-marketing observational study aimed to evaluated the safety profile of Effivia®, a biosimilar of bevacizumab, in mexican patients with different types of cancer.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, 18 years and older.
* Patients with metastatic colorectal cancer,unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, or epithelial ovarian, fallopian tube, or primary peritoneal cancer naive to bevacizumab therapy (Effivia®).
* Provide written informed consent.

Exclusion Criteria:

* History of recent surgery or wound healing complications.
* History of gastrointestinal perforations or fistula.
* History of renal injury and proteinuria.
* Recent surgical intervention.
* Pregnant or nursing women.
* History of bevacizumab, monoclonal antibodies, or CHO cells-derived products hypersensitivity.
* Other safety concerns or bevacizumab contraindications.

Primary outcomes:
measure: Adverse events
timeFrame: From date of patient inclusion to the end of Cycle 1 (each cycle is up to six months)
Secondary outcomes:
Other outcomes:
Locations:
city: León
country: Mexico
facility: UMAE Hospital de Especialidades No. 1
state: Guanajuato
city: Azcapotzalco
country: Mexico
facility: Hospital de Gineco-Obstetricia No. 3
state: Mexico City
city: Cuauhtémoc
country: Mexico
facility: Hospital de Oncología, UMAE Centro Médico Nacional Siglo XXI
state: Mexico City
city: Tlalpan
country: Mexico
facility: Instituto Nacional de Cancerología
state: Mexico City
city: Puebla
country: Mexico
facility: Hospital de Oncología IMSS Puebla
Study officials:
References:
Clinical trial NCT06357468: Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth
Official title: Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Labor
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 237
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women under birth

Brief summary: The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births


Eligibility criteria: Inclusion Criteria:

* Understanding written and spoken German
* Declaration of consent

Exclusion Criteria:

* under 18 years
* incomplete answered questionaire

Primary outcomes:
measure: Pain perception
timeFrame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Secondary outcomes:
measure: Satisfaction with pain therapy
timeFrame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
measure: Pain perception in women with perineal tear grade III
timeFrame: postpartum first 3 days after birth
Other outcomes:
Locations:
city: Halle
country: Germany
facility: University Hospital of Halle
state: Saxony Anhalt
Study officials:
References:
Clinical trial NCT06335368: Assessment of Nutritional and Growth Status in Rett Syndrome Patients
Official title: Assessment of Nutritional and Growth Status in Rett Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rett Syndrome
Neurologic Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rett syndrome patient.

Brief summary: Children with Rett syndrome are in a period of rapid growth, and proper and appropriate nutritional support is very important. Past foreign research papers it has been pointed out that most of these patients have feeding difficulties, dysphagia, and digestive tract abnormalities, are often constipated, and may suffer from osteoporosis and other problems. Lack of proper nutritional support will seriously affect their growth, development and health. in view of There is a lack of relevant research in China, so the investigators would like to use this research to explore the nutritional, growth and postural status of Rett's disease patients, as the reference direction and goal of dietary adjustment and nutritional support for patients, and establish dietary and nutritional strategies for sick children in Taiwan.


Eligibility criteria: Inclusion Criteria:

* Rett syndrome patient.

Exclusion Criteria:

* Not Rett syndrome patient.

Primary outcomes:
measure: gender, age , disease history checklist
timeFrame: 1 year
measure: Change in Body height
timeFrame: 1 year
measure: Change in Body weight
timeFrame: 1 year
measure: Change in knee height
timeFrame: 1 year
measure: Change in arms height
timeFrame: 1 year
measure: Change in waist
timeFrame: 1 year
measure: Change in hip circumferences
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05421468: Timing of Thyroxine Dose In Ramadan
Official title: Timing of Thyroxine Dose In Ramadan; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothyroidism
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized trial comparing two different timing of taking thyroxine in patients with Hypothyroidism during fasting the month of Ramadan.

Detailed description: To date there is debate regarding the best timing of L-thyroxine administration during Ramadan as sufficient evidence is lacking. This study aims to compare two-time points of levothyroxine intake during Ramadan focusing on change in TSH, satisfaction and compliance.

A prospective, randomized, open label, multicenter Study. The first group will be will be instructed to take their L-thyroxin dose as per current guidlines at breaking of fast time (sunset) with sip of water then wait 30-60 minutes to consume Iftar meal. The second group (pre-Fajer prayer), patients are going to be instructed to take L-thyroxin dose immediately before start of fast, i.e. Alfajer (dawn) regardless of Suhoor time. The values of Thyroid stimulating hormone (TSH) will be measured two weeks before Ramadan, and 2-4 weeks after Ramadan for comparison.

Eligibility criteria: Inclusion Criteria:

* Saudi patient (males and female) above 18 years with Primary hypothyroidism on levothyroxine replacement who are willing to fast during Ramadan.
* Patients with controlled thyroid function for last 3 months on same dose of levothyroxine.

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled thyroid function test three months prior Ramadan.
* Thyroid cancer patients who require suppressed TSH.
* Central Hypothyroidism, patient with acute illness.
* Patients diagnosed with malabsorption i.e., Celiac Disease, Short bowel, Bariatric surgeries

  * Use of certain Medications like systemic glucocorticoids, activated charcoal, sucralfate, aluminum hydroxide antacid, bile acid sequestrants, iron, calcium carbonate, PPI, rifampicin, and antiepileptic medications
  * Renal or hepatic disease:
  * Creatinine clearance \<0.6 ml/s or serum creatinine ≥200 μmol/l
  * Alanine transferase ≥2.5 times the upper limit of normal
  * Active liver disease including jaundice, chronic hepatitis, previous liver transplant
  * Unwillingness to be randomized or to sign informed consent
  * Known Psychiatric Disorders
  * Known uncontrolled substance abuse or alcoholism

Primary outcomes:
measure: Thyroid function
timeFrame: 6 - 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Reem Alamoudi
city: Jeddah
country: Saudi Arabia
facility: KingAbullahIMRC
Study officials:
References:
Clinical trial NCT06452368: Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients
Official title: Palatal Versus Buccal Protraction Using Plates Assisted With Facemask in Growing Class III Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class III Malocclusion
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to compare Palatal and buccal protraction using plates assisted with facemask in growing class III patients

Detailed description: A randomized controlled clinical trial was adopted in this study. A total of 20 growing Class III patients were selected from patients seeking orthodontic treatment. The participants were recruited from the department of Orthodontics at Faculty of Dentistry, Mansoura University. No active advertisement was used for participant recruitment, and instead, a convenience sample was formed. Prior to participating in the study, the purpose of the study was explained to the parents of the children and informed consents and assents were obtained according to the guidelines on human research adopted by the Research Ethics Committee Faculty of Dentistry, Mansoura University

Eligibility criteria: Inclusion Criteria:

* Growing patients with age ranged between 8-13 years old.
* Patients should have examination: Class III malocclusion due to maxillary retrusion as verified by clinical and radiographic examination; SNA \<79 and ANB angle \< -1.
* Good likelihood of recall availability.

Exclusion Criteria:

* Vertical skeletal mal relationship.
* History of previous orthodontic/orthopedic treatment.
* Bad habits that may jeopardize the appliance.
* Patients with systemic diseases
* Congenital deformities such as cleft lip and/or palate.

Primary outcomes:
measure: cephalometric radiographs
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mohamed Adel Raghib
state: Dakahlia
Study officials:
References:
Clinical trial NCT02311868: Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hemodialysis
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2014-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in hemodialysis patients. In the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in hemodialysis patients.

Detailed description: In patients with end stage renal disease, alterations in gut microbioma are posited to be responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that has been associated to cardiovascular mortality.

This double blind randomized placebo controlled pilot study evaluates whether Probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower plasma p-cresol concentrations and reduce gastrointestinal symptoms in hemodialysis patients.

Thirty patients on hemodialysis were randomized to receive either Probinul neutro® or placebo for four weeks. Total plasma p-cresol concentrations was assessed at baseline, and 15 and 30 days after treatment start. At the same study times, ease and frequency of defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were quantified by subjective assessment questionnaires.

Eligibility criteria: Inclusion Criteria:

* hemodialysis
* age \>18 years

Exclusion Criteria:

* severe infections
* diabetes
* malignancy
* history of food intolerance
* autoimmune disorders
* severe malnutrition
* clinical conditions requiring artificial feeding
* kidney transplant

Primary outcomes:
measure: Changes in plasma p-cresol concentration
timeFrame: 30 days
Secondary outcomes:
measure: composite outcome of gastrointestinal symptoms
timeFrame: 30 days
Other outcomes:
Locations:
city: Naples
country: Italy
facility: federico II university, department of nephrology
Study officials:
References:
Clinical trial NCT01197768: A Multi-Component Behavioral Nutrition Intervention for Homebound Elderly
Official title: A Multi-Component Behavioral Nutrition Intervention for Homebound Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undernutrition
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Duke University
name: Mayo Clinic
First posted: 2010-09-09
Enrollment: 104
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and feasibility of a multi-level self-management intervention to improve nutritional intake in a group of homebound older adults (HOAs) who are at especially high risk for undernutrition. The study will be guided by the theoretical approaches of the Ecological Model and Social Cognitive Theory and will use a prospective randomized controlled design to estimate whether individually tailored counseling focusing on social and behavioral aspects of eating results in increased caloric intake and improved nutrition-related health outcomes in a sample of 104 HOAs. The investigators hypothesize that intervention at these levels will improve caloric intake and indirectly improve health outcomes.


Eligibility criteria: Inclusion Criteria:

1. at least 65 years of age
2. homebound (based upon Medicare's definition of homebound status)
3. able to communicate or have a caregiver who is able to communicate
4. living in a private residence
5. experiencing either an acute illness or chronic condition
6. not consuming enough calories to maintain body weight or weight loss of \> 5% over past 6 months (if known)

Exclusion Criteria:

1. significantly cognitive impaired (MMSE \< 24 if living alone or MMSE \< 15 if living with caregiver) (if known)
2. terminally ill
3. any cancer diagnosis within the past five years (melanoma excluded)
4. end-stage renal disease
5. gastric or enteral tube-feedings
6. dependent on a ventilator

Primary outcomes:
measure: Caloric Intake
timeFrame: 2 and 8 months post-baseline
Secondary outcomes:
measure: Health services utilization, specifically hospitalization and re-hospitalization
timeFrame: 6 months from follow-up assessment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT00073268: Prevention of Type 2 Diabetes Mellitus in Children
Official title: Prevention of Type 2 Diabetes Mellitus in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
adolescent
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-11-19
Enrollment: 300
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study to examine the short-term effects of supervised exercise on metabolic risk factors for type 2 diabetes mellitus in children from a population that is at high risk for this disease. We hypothesize that exercise will significantly improve insulin sensitivity in all children, especially in children who are already insulin resistant, thereby lowering the risk that they will go on to develop type 2 diabetes mellitus. The specific hypotheses being tested are:

1. Insulin resistance will be most evident in overweight children while an impaired ability of the pancreas to release insulin will be most evident in children with a family history of type 2 diabetes mellitus.
2. Exercise will significantly improve insulin resistance (as measured by the fasting glucose/insulin ratio) with little or no effect on insulin secretory capacity (as measured by circulating insulin concentration at 1, 3, and 5 minutes following an intravenous glucose load) in children.
3. Participation in a school-based health, nutrition, and exercise education program will have long-term beneficial effects on health-related behaviors and on insulin resistance.


Eligibility criteria: Early adolescent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Russ Berrie Pavilion
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
References: