louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00550303: Study Comparing Formulations of Bazedoxifene/Conjugated Estrogens
Official title: An Open-Label, Single-Dose, Non-Randomized, 4-Period Crossover Bioavailability Study of Bazedoxifene Contained in Bazedoxifene/Conjugated Estrogen Tablets Administered to Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-29
Enrollment: 28
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose is to determine bioavailability of Bazedoxifene/conjugated estrogen formulations for future testing purposes.


Eligibility criteria: Inclusion Criteria:

* Healthy, post menopausal women ages 45 to 70

Exclusion Criteria:

* Male subjects

Primary outcomes:
measure: Bioavailability
Secondary outcomes:
measure: Safety & tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06071403: The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants
Official title: The Effects of Time Points to Cease Parenteral Nutrition and IGF-1 on Very Low Birth Weight Infants--A Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Retardation
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 416
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Very low birth weight infants(birth weight less than 1500 grams)

Brief summary: This study aims to estimate short-term and long-term effects of time points to cease parenteral nutrition on very preterm infants, such as growth; to estimate the role of insulin-like growth factor 1 in the growth.

Detailed description: At present, it is unclear when to cease parenteral nutrition, the effects of cessation times on preterm infants' growth, and whether insulin-like growth factor 1 (IGF-1) has a mediation effect in the procedure that nutrients regulate the growth in preterm infants.

Therefore, a prospective cohort study was designed with the aims:

1. to estimate the association between the time to cease parenteral nutrition and the growth in very low birth weight;
2. to investigate the relationship between nutrient volume in parenteral nutrition and growth in very low birth weight;
3. to analyze the IGF-1 mediation effect between nutrient volume and growth regulations.

Eligibility criteria: Inclusion Criteria:

1. Infants with a birth weight less than 1500 grams
2. Infants admitted within 72 hours after birth
3. Infants born from July 1, 2023, to June 30, 2024
4. Written informed consent from parents or guardians

Exclusion Criteria:

1. Infants with congenital abnormality
2. Infants surviving \<7 days after birth

Primary outcomes:
measure: short-term weight and long-term weight
timeFrame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
measure: short-term head circumference and long-term head circumference
timeFrame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
measure: short-term length and long-term length
timeFrame: at 36 weeks' corrected age (CA), CA 3 months, CA 6 months, CA 12 months, CA 18 months, CA 24 months, 36 months' age, 48 months' age and 60 months' age
Secondary outcomes:
Other outcomes:
Locations:
city: Xingtai
country: China
facility: Wei Guo
state: He Bei
Study officials:
affiliation: Peking University
name: Shuaijun Li, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06751303: Patient Preferences for Precision Medicine: Determining Optimal Patient Quality of Life Using PARPi's
Official title: Patient Preferences for Precision Medicine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Quality of Life
Keywords: PARPi
HRD testing
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pragmatic trial which offers HRD testing and for patients HRProficient, a patient decision aid to help them decide whether niraparib is right for them. Whatever they decide, we followup with QoL questionnaires and assessment of time to progression.
Primary purpose: DIAGNOSTIC

Brief summary: Patients with ovarian cancer with defective DNA repair mechanisms derive substantial benefit from PARP inhibitor (PARPi) maintenance therapy. Both niraparib and olaparib are effective inhibitors of PARP, which exploit already defective DNA repair mechanisms (e.g., via BRCA mutations), particularly those with homologous recombination deficiency (HRD). These two PARPis have notably different toxicity profiles, with niraparib showing many more severe side effects. In this Ovarian Cancer Canada funded study, we will implement perform HRD testing for ovarian cancer patients in Saskatchewan with response to platinum-based chemotherapy. This information will provide personalized and precision estimates about the amount of benefit that can be expected from taking a PARPi. We will evaluate both treatment outcomes and quality of life in a real-world study setting, to inform future decision-making regarding efficacy, quality of life and cost-effectiveness of PARPi therapy, specifically for niraparib.

We hypothesize that for patients who are homologous recombinant proficient (HRP), the median 32.7-month incremental benefit (in delaying cancer progression) from taking a PARPi (niraparib is the only PARPi approved in this setting) will not be seen as being value-add when balanced by the decreased quality of life that accompanies the first 6-12 weeks of therapy. We also hypothesize that for women who are HRP, that PARPi therapy will not be cost-efficient.


Eligibility criteria: Inclusion Criteria:

* Known or suspected stage 3/4 high grade serous or endometrioid ovarian cancer Able to provide oral consent and complete questionnaires in English as per study protocol

Exclusion Criteria:

* Ineligible for Maintenace PARPi therapy Refusal to undergo HRD testing

Primary outcomes:
measure: Patient decision for use of PARPi therapy
timeFrame: 6 Monhs
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatchewan Cancer Center
state: S
Study officials:
References:
Clinical trial NCT01474603: Impact of n-3 Polyunsaturated Fatty Acids in a Protein-enriched Diet With Low GI in Type 2 Diabetes Patients
Official title: IMpact of n-3 Polyunsaturated Fatty Acids With a Protein-Enriched DiEt With Low Glycemic Index on Metabolic and Inflammatory Parameters in Type 2 Diabetic and Obese Patients: an Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight
Obese
Insulin Resistance
Diabetes
Keywords: observational study
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Enervit Spa (company)
First posted: 2011-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: overweight to obese insulin resistant, prediabetic and diabetic patients

Brief summary: Type 2 diabetes is tightly associated with overweight and obesity. Inflammatory processes are crucial triggers for insulin resistance that paves the way to type 2 diabetes. In a previous study the investigators have shown that n-3 polyunsaturated fatty acids diminish adipose tissue inflammation in morbidly obese non-diabetic subjects. in this observational study the investigators will apply n-3 polyunsaturated fatty acids as addition to a protein-enriched diet with low glycemic index to overweight and obese patients with insulin resistance, prediabetes and manifest type 2 diabetes over up to 6 months. Primary efficacy parameters are changes from baseline in HbA1c and body weight for for type 2 diabetes and all other patients, respectively.


Eligibility criteria: Inclusion Criteria:

* overweight or obesity AND
* insulin resistant OR pre-diabetes OR type 2 diabetes

Exclusion Criteria:

* changes in anti-diabetic medication in the lat two months
* acute illness during the last two weeks
* HIV infection
* hepatitis of other clinically significant hepatic disease other than non-alcoholic hepatic steatosis
* severe or insufficiently treated cardiovascular, renal (GFR-MDRD \< 60 ml/min) or pulmonary disease
* Macroproteinuria (\> 300 mg/g creatinine)
* clinically significant or insufficiently treated thyroid disease
* anemia
* active malignant disease
* inborn or acquired coagulopathy

Primary outcomes:
measure: HbA1c change from baseline (type 2 diabetes patients)
timeFrame: 3 months
measure: body weight change from baseline (non-diabetic patients)
timeFrame: 3 months
Secondary outcomes:
measure: change from baseline of inflammatory and metabolic parameters
timeFrame: 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dept. Medicine III, Medical University of Vienna
Study officials:
References:
citation: Moosheer SM, Waldschutz W, Itariu BK, Brath H, Stulnig TM. A protein-enriched low glycemic index diet with omega-3 polyunsaturated fatty acid supplementation exerts beneficial effects on metabolic control in type 2 diabetes. Prim Care Diabetes. 2014 Dec;8(4):308-14. doi: 10.1016/j.pcd.2014.02.004. Epub 2014 Mar 19.
Clinical trial NCT01503203: Physical Virtual Training for Older Women
Official title: Physical Virtual Training Effectiveness on Nonspecific Chronic Low Back Pain, Body Balance, Functional Autonomy and Mood of Older Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Keywords: Older
virtual systems
low back pain
postural balance
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 39
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be assess the effectiveness of the physical virtual training on nonspecific chronic low back pain, body balance, functional autonomy and mood of older women. Two groups will be formed. One will do strength exercises and core training. The other group will do the same exercises more virtual activities with Nintendo Wii. Will be measure pre and post-intervention of the responses already shown above.


Eligibility criteria: Inclusion Criteria:

* subjects with nonspecific chronic low back pain
* patients without involvement in regular exercise program

Exclusion Criteria:

* patients not recommended for physical exercise (Physical Activity Readiness Questionnaire PAR-Q)
* trunk surgery
* cancer
* injuries in lower extremity
* neurological or vestibular disease

Primary outcomes:
measure: Pain
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Body Balance
timeFrame: up to 8 weeks
measure: Functional autonomy
timeFrame: up to 8 weeks
measure: Mood
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Fisioprime Clinical of Physiotherapy
Study officials:
affiliation: Gama Filho University
name: Elirez B da Silva, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03333603: Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenia Patients
Official title: Pharmacokinetics and Safety Studies of Esomeprazole Use in Schizophrenic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2017-11-07
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazoleon Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic and safety for the esomeprazole use for schizophrenia

Detailed description: Investigators prepare to recruit 30 schizophrenia patients in one year. Investigators will conduct a 8-week open label clinical trial for evaluation of the pharmacokinetic and safety of esomeprazole use for the schizophrenia. Investigators will give 40 mg/day esomeprazole in the first two weeks and 80 mg/day from the third week to the end of the trial. Investigators will check the area under the concentration of metabolites of esomeprazole on Day 1, Day 14 and Day 56 and the genotype of CYP2C19. The GI symptoms and related drug side effects will be evaluated.

Eligibility criteria: Inclusion criteria

1. 20-65 years old
2. Diagnosed as DSM-IV schizophrenia
3. No adjustment of dose of major antipsychotics for at least 4 weeks
4. Competence for inform consent

Exclusion criteria

1. Diagnosed with schizoaffective disorder or bipolar affective disorder or organic psychotic disorder
2. Meet the diagnostic criteria of any substance abuse or dependence in the past 6 months
3. History or evidence of any clinically significant medical or neurological disease, such as autoimmune disease, cancer, epilepsy, etc.
4. Mental retardation or pervasive developmental disorders
5. Past history of allergy to Esomeprazole
6. patient who is taking clozapine、 Depakin or Diazepam
7. Pregnant
8. The patient is under the order of involuntary admission

Primary outcomes:
measure: Plasma Concentration analysis
timeFrame: It will be assessed on Day 1 predose, Day 14 90 mins post dose, and Day 56 90 mins post dose
Secondary outcomes:
measure: CYP2C19 genotypes analysis
timeFrame: The genotype will be assessed on Day 1
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
Study officials:
affiliation: Visiting Staff
name: Chih-Min Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03251703: Ultrasound-Guided Suprascapular Pulsed Radiofrequency
Official title: Effects of Ultrasound-Guided Suprascapular Pulsed Radiofrequency Therapy on Chronic Shoulder Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PAIN, INTRACTABLE, Shoulder
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: shoulder pain lasting at least 3 months.

Brief summary: Shoulder pain is the second most common musculoskeletal disease in adults, and it often becomes chronic due to treatment difficulties.

Pulsed radiofrequency (PRF) therapy has become increasingly popular in the treatment of chronic shoulder pain due to its long duration of action and non-destructive method.

Detailed description: These patients lacked pain control despite systemic analgesics and conservative therapy and applied to our pain polyclinics for shoulder pain lasting at least 3 months.

The ultrasound-guided SSPRF was performed in those patients with a reduction of 50% or more VAS score and those that reported healing in the AROM in the diagnostic SNB.

The resting, motion and sleeping shoulder pain assessments of the patients were done using a visual analog scale (VAS). The shoulder joint function was assessed using the Shoulder Pain and Disability Index (SPADI) questionnaire and the active range of motion (AROM) of the joint was measured using a goniometer In this study, investigators aimed to reveal the effects of ultrasound-guided suprascapular PRF (SSPRF) therapy applied to patients with chronic shoulder pain on both shoulder pain and function.

Eligibility criteria: Inclusion Criteria:

Patients 18 years of age or older who were diagnosed with at least one of the following: adhesive capsulitis of the shoulder (M75.0), rotator cuff syndrome (M75.1), and impingement syndrome of shoulder (M75.4) according to the ICD-10 classifications. These patients lacked pain control despite systemic analgesics and conservative therapy (like physiotherapy) and applied to our pain polyclinics for shoulder pain lasting at least 3 months.

Exclusion Criteria:

Patients with other diseases causing chronic pain, those with neuropathic pain, those who had undergone surgery on the same shoulder, those with an allergy history from local anesthesia, those with abnormal coagulation tests, and those with cardiac pacemakers were excluded from this study.

Primary outcomes:
measure: Evaluation of The Efficacy of Ultrasound-Guided Suprascapular Pulsed Radiofrequency
timeFrame: 1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05535803: Treatment of Laryngotracheal Stenosis Using Mesenchymal Stem Cells
Official title: Treatment of Laryngotracheal Stenosis Using Autologous Olfactory-mucosa-derived Mesenchymal Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Tracheal Stenosis
Laryngeal Stenosis
Keywords: mesenchymal stem cells
Tracheal/Laryngeal Stenosis
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: The Republican Center for Research and Practice in Otolaryngology
First posted: 2022-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial evaluates the safety and efficacy of the olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis

Detailed description: Trial evaluating the safety and efficacy of olfactory mucosa-derived mesenchymal stem cells based therapy for the patients with chronic laryngeal and tracheal stenosis with/without cartilage defects

Mesenchymal stem cells are obtained from tissue biopsy of olfactory mucosa using explant method. Biomass of autologous mesenchymal stem cells in 10% human albumin solution is injected submucosally around and over the tissue after removal of a granuloma tissue during surgical intervention.

Eligibility criteria: Inclusion Criteria:

-confirmed diagnosis of chronic laryngeal or tracheal stenosis;

Exclusion Criteria:

* refuse of patient to participate in the trial;
* acute infectious diseases;
* chronic mental disorders with severe manifestations;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction;
* cachexia of any origin;
* malignant neoplasms.

Primary outcomes:
measure: Number of patients who didn't require the repeated surgical interventions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Institute for biophysics and cellular engineering NAS of Belarus
name: Andrei Hancharou, Dr
role: STUDY_DIRECTOR
affiliation: The Republican Center for Research and Practice in Otolaryngology
name: Elvira Strinkevich, Dr
role: STUDY_DIRECTOR
affiliation: The Republican Center for Research and Practice in Otolaryngology
name: Valery Chekan, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02331303: A Drug Utilization Study of Radium-223 in Sweden
Official title: A Drug Utilization Study of Xofigo Use in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-01-06
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. It will consist of mCRPC patients and potentially some other patient groups in whom Xofigo may be used off-label including women, children, cancer patients having bone metastasis with a diagnosis other than CRPC, and patients with repeated courses of treatment or in excess of those recommended in the label. This study will be based on data extracted from two pre-established data sources: 15 nuclear medicine centers across Sweden and the Swedish National Cancer Registry.

Brief summary: The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.


Eligibility criteria: Inclusion Criteria:

* Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study

Exclusion Criteria:

* Patients receiving Xofigo in a clinical trial will not be included in this study

Primary outcomes:
measure: Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use
timeFrame: Up to 2 years
measure: Proportion of being women of Xofigo use
timeFrame: Up to 2 years
measure: Proportion of being children of Xofigo use
timeFrame: Up to 2 years
measure: Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV
timeFrame: Up to 2 years
measure: Dosage of Xofigo (kBq/kg)
timeFrame: Up to 2 years
measure: Proportion of participants of dose outside label recommendation
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: