louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00658294: Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles
Official title: Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles in Patients With Inoperable Alveolar Echinococcosis Using PET-CT and EmII/3-10 Serology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alveolar Echinococcosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-04-14
Enrollment: 34
Sex: ALL
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: Patients with inoperable alveolar echinococchosis

Brief summary: The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to assess the parasitocidal effect of benzimidazoles

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* Patients with inoperable alveolar echinococcosis
* With negative PET-CT
* EmII/3-10 serology under long-term chemotherapy with benzimidazoles

Exclusion criteria:

* Positive PET-CT
* Positive EmII-3-10 Serology
* No compliance
* Reduced life expectancy
* Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: Beat Müllhaupt 01 Studienregister MasterAdmins
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Mullhaupt B. Outcome after Discontinuing Long-Term Benzimidazole Treatment in 11 Patients with Non-resectable Alveolar Echinococcosis with Negative FDG-PET/CT and Anti-EmII/3-10 Serology. PLoS Negl Trop Dis. 2015 Sep 21;9(9):e0003964. doi: 10.1371/journal.pntd.0003964. eCollection 2015.
Clinical trial NCT02246894: A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Official title: An Open Multicentre Phase III Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Severe Haemophilia A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia A
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no

Brief summary: The main objectives of this study are:

* to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed).
* to assess clinical outcome when treating a bleed with Optivate®.
* to evaluate Optivate® in terms of clinical tolerance and safety in children under the age of 6 years. .
* to assess FVIII inhibitor development during the study.


Eligibility criteria: Inclusion Criteria:

* Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.

Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Consumption of FVIII
timeFrame: Day 0 to Week 26
Secondary outcomes:
Other outcomes:
Locations:
city: W. Chodzki Str.
country: Poland
facility: Children's Haematology and Oncology Clinic, Ul.
state: Lublin
city: Krakow
country: Poland
facility: Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
city: Poznan
country: Poland
facility: Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
city: Warsaw
country: Poland
facility: Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
city: Wroclaw
country: Poland
facility: Children's Clinic for Bone Marrow Transplant, Oncology and Haematology, Medical University of Wroclaw, 44 Bujwida str.
Study officials:
References:
Clinical trial NCT03082794: Dietary Effects on Weight Loss and Lipid Profile in Sedentary Men
Official title: Investigating the Effects of Negative Calorie Diet Compared With Low-Calorie Diet on Weigh Loss and Lipid Profile in Sedentary Overweight/Obese Middle-Aged and Older Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Men
Life Style
Lipid Metabolism Disorders
Obesity
Overweight
Keywords: Dietary Formulations
Lifestyle
Obesity
Overweight
weight loss
Lead sponsor: P.L.Shupik National Medical Academy of Post-Graduate Education
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 104
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Negative-calorie diet is among the popular dieting guides for weight loss; however, there is still little knowledge about this method. The present study aimed to determine the effects of negative-calorie diet on weight loss and lipid profile, and to compare its efficiency with low-calorie diet in men.


Eligibility criteria: Inclusion Criteria:

* Non-smokers
* Weight-stable (± 2 kg, for more than one year)
* No history of regular exercise (in at least three months before the study).

Exclusion Criteria:

* History of medical disorders (CVD and other such as diabetes, depression, eating disorders, chronic medications, kidney disease, cancer, food allergies or intolerances to items used in meals, abnormality in thyroid or Electrocardiograph
* History of anti-obesity medication or weight loss drugs or dietary supplementations for weight control.

Primary outcomes:
measure: Weight
timeFrame: Baseline
measure: Total cholesterol (Total-C)
timeFrame: Baseline
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: Baseline
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: Baseline
measure: Triglycerides (TG)
timeFrame: Baseline
Secondary outcomes:
measure: Weight
timeFrame: 3-month
measure: Total cholesterol (Total-C)
timeFrame: 3-month
measure: High-density lipoprotein -cholesterol (HDL-C)
timeFrame: 3-month
measure: Low-density lipoprotein -cholesterol (LDL-C)
timeFrame: 3-month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04338594: Impact of the Profession on Parenthood
Official title: Impact of the Profession on Parenthood
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parenthood Status
Keywords: Parenthood
Work
child
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 10000
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Workers or retirees

Brief summary: Professional constraints can have major causes on personal and couple life. In particular, some professions with major professional constraints that can be particularly impacted, such as doctors and healthcare workers.

The main objective was to demonstrate the impact of work on the desire and the fact to have children

Detailed description: This is an observational study by questionnaire via an internet link. The self-questionnaire will assess parenthood, socio-demographic parameters, and the perception of the profession.

Eligibility criteria: Inclusion Criteria:

* All volunteers
* Workers or retirees

Exclusion Criteria:

* none

Primary outcomes:
measure: parenthood
timeFrame: Day 1
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: Day 1
measure: occupation perception
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University hospital, Clermont-Ferrand
Study officials:
References:
Clinical trial NCT01659294: Diabetes Outcomes and Nurse Case Manager Study
Official title: Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
outcomes
case management
Lead sponsor: BCDiabetes.Ca
Sponsor class: NETWORK
Collaborators: name: Sanofi
First posted: 2012-08-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.

Detailed description: The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources:

1. referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
2. referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1).

Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* A1c \> 8.0 or
* BP \> 140/90 or
* LDL cholesterol \> 2.0 (72 mg/dl)

Exclusion Criteria:

* inability to speak English or to be assisted by somebody fluent in English

Primary outcomes:
measure: A1c
timeFrame: 6 months
measure: diabetes distress (DDS)
timeFrame: 6 months
Secondary outcomes:
measure: blood pressure
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: Self-management behaviours
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Patient motivation
timeFrame: 6 months
measure: Diabetes-specific Social Support
timeFrame: 6 months
measure: Depressive Symptoms Severity
timeFrame: 6 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Bcdiabetes.Ca
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tom Elliott, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997394: The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD
Official title: The Effect of Prayer on Dyspnea Severity, Anxiety and Spiritual Well-Being in Individuals With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: DYSPNEA
SPIRITUAL GOODNESS
ANXIETY
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a semi-experimental type of study. It consists of two groups: experiment and control.
Primary purpose: TREATMENT

Brief summary: This study will be conducted in order to examine the effect of prayer to individuals with COPD on the severity of dyspnea, anxiety and spiritual well-being experienced by patients.

Detailed description: This study will be conducted on people with COPD. People with COPD disease will be divided into two groups. The experimental group will be given a prayer lesson for a month. Prayer listening will not be performed to the control group. At the end of one month, the severity of dyspnea, anxiety and spiritual well-being levels of people in both groups will be re-evaluated.

Eligibility criteria: Inclusion Criteria:

* 90 individuals (45 experiments, 45 controls) who can be contacted, who have agreed to participate in the study
* who are literate, can speak Turkish
* who have not participated in a similar application of this study before
* who have agreed to participate in the study after being informed about the research
* are 18 years old and over, with a COPD diagnosis will be taken

Exclusion Criteria:

* Individuals with mental and hearing problems, who have lost a family member and someone close to them in the last year
* who are using tranquilizers/antidepressants
* who have experienced a traumatic situation such as divorce will be excluded from the sample.

Primary outcomes:
measure: dyspnea 12 scale
timeFrame: 1 month
measure: Beck anxiety scale
timeFrame: 1 month
measure: Spiritual Well-Being Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Zile Devlet Hastanesi
Study officials:
affiliation: Tokat Zile Devlet Hatanesi
name: Gülden Kaygusuz Gülden Kaygusuz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03026894: Association of Force Distribution and Bone Resorption
Official title: Association of Occlusal Force Distribution and Bone Resorption in Implant Supported Overdentures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Resorption
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 46
Sex: ALL
Minimum age (years): 49
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the residual ridge resorption at anterior and posterior maxillary and posterior mandibular ridges among conventional complete dentures and implant overdenture wearers, and determine its association with the relative occlusal forces distribution, treatment groups and other patient variables.

Detailed description: A total of forty-six edentulous patients participated in this clinical study divided into two groups as following; complete denture group (CD) consists of 23 patients wearing conventional complete dentures and another Implant overdenture group (IOD) consists of 23 patients wearing mandibular complete overdenture with 2 implants. Two panoramic radiographs at baseline and in a follow-up to 7 years were used to measure the ratio of bone changes between the anatomical bone area and the reference area in the maxillary and the mandibular ridges. The occlusal contacts percentage of force in maximum intercuspation anteriorly and posteriorly were recorded for both groups by using T-Scan III system.

Oral and written information in English or Malay language, regarding the study, was provided and written consent obtained before enrolment.

Eligibility criteria: Inclusion Criteria:

* Patients wearing mandibular IODs opposing conventional maxillary CDs.
* Patients wearing conventional maxillary and mandibular CDs.
* Clearly visible anatomic landmarks of the panoramic radiography image.

Exclusion Criteria:

* Patients with a history of temporomandibular joint dysfunction.

Primary outcomes:
measure: Residual ridge resorption
timeFrame: 7 years
Secondary outcomes:
measure: Occlusal force distribution
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01262794: Pharmacokinetic (PK)/Pharmacodynamic (PD), Study of Single-dose Subcutaneous CDP6038 in Healthy Japanese Male Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Single-center, Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of CDP6038 Administered Subcutaneously to Healthy Japanese Males
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy volunteers
Japanese
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To evaluate the safety and tolerability of CDP6038 following single dose subcutaneous (sc) administration of CDP6038 to Japanese subjects.

To evaluate the Pharmacokinetics of CDP6038 following single dose sc administration of CDP6038 to Japanese subjects


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese volunteers

Exclusion Criteria:

* Subject has participated in any other clinical drug study (including a biologic product or a medical device) within 5 PK half-lives or 3 months (whichever is longer) prior to Screening, or the subject is currently participating in another clinical study.
* Subject is not healthy (eg, taking any drug treatments, any psychological or emotional problems, a drug/alcohol abuse or a having a history of drug/alcohol abuse, having abnormal safety parameters)

Primary outcomes:
measure: Maximum drug concentration (Cmax)
timeFrame: Multiple sampling from 0 to 113 days following single dose
measure: Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUC0-t)
timeFrame: Multiple sampling from 0 to 113 days following single dose
measure: Area under the plasma drug concentration versus time curve extrapolated to infinity (AUC)
timeFrame: Multiple sampling from 0 to 113 days following single dose
measure: Apparent volume of distribution (Vz/F)
timeFrame: Multiple sampling from 0 to 113 days following single dose
measure: Apparent total body clearance (CL/F)
timeFrame: Multiple sampling from 0 to 113 days following single dose
measure: Terminal elimination half-life (T½)
timeFrame: Multiple sampling from 0 to 113 days following single dose
Secondary outcomes:
measure: PK/PD relationship between systemic CDP6038 exposure and suppression of selected acute phase markers (such as C-reactive protein), following single subcutaneous doses of CDP6038 in Japanese subjects
timeFrame: Multiple sampling from 0 to 15 weeks following single dose
measure: Immunogenicity of single subcutaneous doses of CDP6038 in Japanese subjects
timeFrame: Multiple sampling from 0 to 15 weeks following single dose
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
state: Surrey
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04580394: Crossover Trial of AD109 in Obstructive Sleep Apnea
Official title: Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Lead sponsor: Apnimed
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.

Detailed description: The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.

Eligibility criteria: Inclusion Criteria:

* Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to \<20, or AHI ≥20 if meets other PSG criteria

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Primary outcomes:
measure: Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
timeFrame: 1 night (treatment duration) (0-8 hours collected continuously)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Preferred Research Partners, Inc.
state: Arkansas
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Brandon
country: United States
facility: Teradan Clinical Trials
state: Florida
city: Miami
country: United States
facility: Clinical Trials of Florida
state: Florida
city: Gainesville
country: United States
facility: The Neurological Center of North Georgia
state: Georgia
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
Study officials:
References:
Clinical trial NCT01353794: Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer
Official title: Prospective, Multicentric, Large Scale Observational Study to Evaluate Effectiveness and Safety of Nexavar® in Advanced Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Carcinoma, Renal Cell
Keywords: SORAFENIB
RENAL CELL CARCINOMA
TYROSINE KINASE INHIBITOR
OBSERVATIONAL STUDY
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of advanced RCC

Brief summary: The objective of this Non-Interventional study is to evaluate the effectiveness \& safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age \>70 years) and younger patients (age \<70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.

Primary outcomes:
measure: Efficacy related variables are status of tumor / metastases.
timeFrame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
measure: Efficacy related variables are patient's performance status.
timeFrame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
measure: Efficacy related variables are efficacy assessment by the physician.
timeFrame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
measure: Efficacy related variable - Quality of Life (QOL) assessment by the patient
timeFrame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Secondary outcomes:
measure: General tolerability assessment by physician and reports of adverse events.
timeFrame: After 12 months, or at discontinuation of therapy or at end of study (whatever is earlier)
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: