louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02685189: Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
Official title: Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hyperbilirubinemia
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2016-02-18
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.

Brief summary: The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".

Detailed description: The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration

Eligibility criteria: Inclusion Criteria:

* All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.

Exclusion Criteria:

-

Primary outcomes:
measure: NEUROLOGICAL EXAMINATION; Child Behavior Check List
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
name: Nancy Ruiz, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04814589: Bioequivalence of Ezetimibe Tablets in Healthy Subjects
Official title: Bioequivalence of Ezetimibe Tablets in Healthy Subjects: A Single-dose and Two-period Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Therapeutic Equivalency
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: According to the relevant provisions of bioequivalence test, ezetimibe Tablets (test preparation, T, 10mg / tablet) provided by China Resources Saike Pharmaceutical Co., Ltd. were compared with Ezetrol ® (reference preparation, R, 10mg / tablet) produced by MSD Pharma (Singapore) Pte. Ltd. to evaluate the bioequivalence of single dose in healthy subjects under fasting and fed conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects ≥18 years of age, with appropriate sex ratio;
* The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test and Nicotine test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Alanine aminotransferase \>1.0×ULN ,Aspartate aminotransferase \>1.0×ULN or Total bilirubin \>1.0×ULN.
* Subjects with allergic constitution.
* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 90 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 90 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 90 days
measure: Incidence of abnormal blood pressure
timeFrame: 90 days
measure: Incidence of abnormal temperature
timeFrame: 90 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase Ⅰ Clinical Research Center
state: Shandong
Study officials:
affiliation: the study director of phase I clinical research center
name: yu Cao, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04319289: Effect of Aerobic Interval Training With Vitamin D Supplement on Functional Capacity and Perceived Myalgia
Official title: Effect of Aerobic Interval Training Combined With Vitamin D Supplement on Functional Capacity and Perceived Myalgia in Middle Aged Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 45
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate whether there will be an effect of adding a program of aerobic interval training in managing patients suffering from myalgia associated with vitamin D deficiency.

Detailed description: Forty five women complaining from myalgia with vitamin D deficiency participating in this study. Their ages are ranged from 30 to 40 years.

They are assigned randomly into three groups:

* Group (A): included 15 patients who are participating in an aerobic interval training exercise program with vitamin D supplementation (cholecalciferol 400 IU/day).
* Group (B): included 15 patients who are receiving vitamin D supplementation only (cholecalciferol 400 IU/day).
* Group (C): included 15 patients who are participating in an interval training exercise program only.

The intervention will last for 12 weeks

Eligibility criteria: Inclusion Criteria:

* Forty five sedentry women with non specific myalgia pain.
* The patients' ages ranged from 30 -40 years.
* All patients have non specific muscle pain for more than 2 months.
* They have vitamin D deficiency.
* All patients have BMI from 25 to 34.9 kg/m2.
* All patients were clinically and medically stable when attending the study.

Exclusion Criteria:

* Unstable cardiovascular and chest problems.
* Patients with diseases which affect vitamin D level as a history of rheumatic or metabolic bone diseases and diabetes.
* Patients taking drugs which affect vitamin D level as steroids and anticonvulsants drugs .
* Musculoskeletal disorders which may affect their physical ability to do the exercises.

Primary outcomes:
measure: Concentration of Plasma Serum vitamin D level (25OHD)
timeFrame: It is performed before and after the study(12 weeks interval) for all groups
measure: Description of Functional capacity efficiency
timeFrame: It is performed before and after the study(12 weeks interval) for all groups
measure: Intensity of non specific muscle pain (myalgia)
timeFrame: It is performed before and after the study(12 weeks interval) for all groups
measure: Description of the improvement in Quality of life
timeFrame: It is performed before and after the study(12 weeks interval) for all groups
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT02865889: Cost-Effectiveness and Patients Satisfaction of Conventional vs Robotic-Assisted Laparoscopy in Gynecologic Oncologic Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: UTERINE CERVICAL NEOPLASMS
ENDOMETRIAL NEOPLASMS
Keywords: laparoscopic surgery
Uterine Neoplasms
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 343
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Endometrial and cervical cancer

Brief summary: Laparoscopic surgery is gaining currency in the field of oncologic care, particularly for colorectal and gynecologic cancers. This innovation could be used either for staging purpose and therefore could steer global therapeutic options or for surgical management only.

Increase knowledge and skills lead to an increase in the number and rate of the women this innovation could be offered. The project team observed a shift from traditional surgical management (abdominal radical surgery) towards laparoscopic with a focus on lymphadenectomy.

This innovation however increases some costs (the surgical stage) but decrease some others (the post surgical stage).

Foreseeing the pace of the dissemination needs to have objective and reliable data about who had access to laparoscopic surgery and who didn't (and why) and accurate assessment of related costs.

This program will focus on uterine cancer (both cervix and corpus).


Eligibility criteria: Inclusion Criteria:

* Age\>18 years
* Endometrial or cervical cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Cost comparison between Conventional vs Robotic-Assisted Laparoscopy
timeFrame: 2 years
measure: Comparison of the effectiveness of procedures (Conventional vs Robotic-Assisted Laparoscopy)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
affiliation: Institut Paoli-Calmettes
name: Eric Lambaudie, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00692289: Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer
Official title: Quality of Life Analysis of Arimidex Treatment in Postmenopausal Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Quality of Life
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 1510
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Postmenopausal, hormonreceptor positive patients with early breast cancer treated with Arimidex (in accordance with the local SmPC).

Brief summary: This is an open label, non-interventional quality of life analysis for Arimidex treated postmenopausal patients in early breast cancer by investigator's questionnaire


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Postmenopausal, hormon receptor positive patients with early breast cancer treated with Arimidex
* Investigators are requested to recruit patients only with at least 1 month prior Arimidex treatment.

Exclusion Criteria:

* Allergy to substance of medication
* Pre-perimenopausal woman
* Woman not eligible for treatment

Primary outcomes:
measure: Elements of the investigator questionnaire SF RAND-36 questionnaire
timeFrame: Quarterly (plus or minus 3 days )
Secondary outcomes:
measure: Investigator Assessment Report
timeFrame: Yearly (plus or minus 1 week )
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Research Site
city: Komlo
country: Hungary
facility: Research Site
city: Miskolc
country: Hungary
facility: Research Site
city: Mohacs
country: Hungary
facility: Research Site
city: Vac
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
Study officials:
affiliation: National Institute of Oncology
name: Zsolt Horváth, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca Hungary
name: Csaba Csongvai
role: STUDY_DIRECTOR
affiliation: AstraZeneca Hungary
name: Éva Gulyás
role: STUDY_CHAIR
References:
Clinical trial NCT02936089: Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+
Official title: Risk Stratification-directed Therapy for Acute Myeloid Leukemia With t(8;21) /AML1-ETO-positive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Risk Stratification
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
First posted: 2016-10-18
Enrollment: 207
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with newly diagnosed AML1/ETO-positive AML took risk-directed stratification therapy based on c-KIT and ASXL1 mutations and measurable residual disease (MRD). low risk (LR) group (KIT-ASXL1- with main molecular response (MMR)) was recommended to chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT). Intermediate risk (IR) group (KIT+/ASXL1+ with MMR) was suggested for auto-HSCT or HLA-matched HSCT. High risk (HR) group (KIT+ASXL1+ or without MMR) was treated with allogeneic (allo-) HSCT.
Primary purpose: TREATMENT

Brief summary: Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses. There were significant differences in the therapeutic effect between different subgroups of AE AML. Therefore, risk stratification-directed therapy is very necessary for AE AML.

Detailed description: Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses.There were significant differences in the therapeutic effect between different subgroups of AE AML. For example, patients with c-kit mutation had higher relapse rate and lower overall survival, compared with those without c-kit mutation. Therefore, risk stratification-directed therapy is very necessary for AE AML. The purpose of this study is to establish risk stratification-directed therapy for AE AML.

Eligibility criteria: Inclusion Criteria:

* AE AML aged 14-70
* No abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Expected survival time is more than 2 months

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: overall survival (OS)
timeFrame: 3 year
Secondary outcomes:
measure: leukemia relapse rate
timeFrame: 3 year
measure: disease-free survival (DFS)
timeFrame: 3 year
measure: event Free Survival (EFS)
timeFrame: 3 year
Other outcomes:
Locations:
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Dan Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00139789: A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis
Official title: A Multicenter, Open-label Randomized Crossover Trial to Assess Subject Preference for Kemstro™ Compared to Conventional Baclofen Tablets in Subjects With Stable Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This was a multicenter, open-label, randomized, crossover trial in subjects with MS who were already taking a stable dose of baclofen (up to 80 mg/day) for spasticity. The trial was designed to assess subject preference for Kemstro or conventional baclofen. At Visit 1, subjects were screened, and if qualified, were randomly assigned to one of two following treatment sequences: Kemstro/conventional baclofen or conventional baclofen/Kemstro.


Eligibility criteria: Inclusion Criteria:

* stable dose of baclofen

Exclusion Criteria:

* not stable dosing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Schwarz
state: Wisconsin
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01170689: The Prevalence of Obesity For Schizophrenia Inpatients in Taiwan
Official title: The Prevalence of Obesity For Schizophrenia Inpatients in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Obesity
Keywords: Schizophrenia
inpatient
obesity
prevalence
Lead sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 710
Sex: ALL
Minimum age (years): 20
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 710 adult schizophrenia patients living in the chronic ward in Tsau-Tun psychiatric center during the first week in March 2010

Brief summary: This study is the first hospital-based, cross-sectional study to discuss the prevalence of obesity among 710 inpatients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

1. diagnosis as ICD 295
2. Living in rehabilitation ward during 2010/03/22\~2010/04/02

Exclusion Criteria:

none

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: cross-sectional study, check one time
Secondary outcomes:
measure: waist circumference
timeFrame: cross-sectional study, check for one time
Other outcomes:
Locations:
city: Nan-Tou
country: Taiwan
facility: Tsao-Tun Psychiatric Center
Study officials:
affiliation: Tsaotun Psychiatric Center
name: Ching Han-Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790789: Stress Reduction in Ovarian Cancer
Official title: Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian, Fallopian, and Primary Peritoneal Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS).
* Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS.
* Receive chemotherapy at the University of Wisconsin-Madison.
* Subjects must be at least 18 years of age.
* English-speaking
* Subjects must be able to use audio media, and read and understand the study manual.
* ECOG performance status 0-2.
* Subjects must have a phone.

Exclusion Criteria:

* Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration.
* Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer.
* Subjects with diagnosis of Chronic Fatigue Syndrome (CFS).
* Subjects unable to use audio media due to auditory dysfunction.
* Subjects unable to read written English.
* Subjects who are prisoners or incarcerated.

Primary outcomes:
measure: Fatigue
timeFrame: 18 weeks (completion of chemotherapy)
Secondary outcomes:
measure: Natural Killer Cell Activity
timeFrame: 18 weeks (completion of chemotherapy)
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Stephen Rose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118389: Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure
Official title: The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure in Patients With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure

Detailed description: The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure in Patients with Obesity

Eligibility criteria: Inclusion Criteria:

1. age：14\~60years
2. BMI ≥ 28kg/m2
3. without liver, kidney, gastrointestinal and other major organic serious diseases,lactating women, pregnancy

Primary outcomes:
measure: Dual energy X-ray absorptiometry
timeFrame: 5 weeks
Secondary outcomes:
measure: lab testing
timeFrame: 5weeks
Other outcomes:
measure: blood pressure
timeFrame: 5 weeks
Locations:
Study officials:
affiliation: Shang Tenth People's Hospital
name: Qu Shen, PhD
role: STUDY_DIRECTOR
References: