louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00237146: Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy
Official title: Study to Evaluate Zoledronic Acid on Quality of Life and Skeletal-related Events as Adjuvant Treatment in Patients With Hormone-naïve Prostate Cancer and Bone Metastasis Who Have Undergone Orchiectomy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: Prostate cancer
Zoledronic acid
Bone metastasis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-12
Enrollment: 38
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open, multicenter and prospective study to evaluate the impact of the treatment with zoledronic acid 4 mg, on the quality of life and the skeletal-related events in patients with prostate cancer and bone metastasis that responds to hormonal therapy. Zoledronic acid is given to patients in a 15 minute-infusion every 4 weeks until a skeletal-related event occurs.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* histologically confirmed adenocarcinoma of the prostate.
* Orchidectomy within the four previous weeks to enter the study.
* bone metastasis evidenced by bone scan.
* A hip DEXA study with a DS \< 3.
* No hormonal therapy previous to enter the study.
* ECOG performance score of 0-2.
* Signed written informed consent.

Exclusion Criteria:

* Abnormal renal function evidenced by a creatinine clearance ≤60 ml/min.
* Any kind of hormonal therapy for prostate cancer previous to enter the study.
* Serum calcium corrected for albumin level \< 8.0 mg/dl.
* WBC \< 3.0x10\^3, ANC \< 1500/mm3, Hemoglobin \< 8.0 g/dl, platelets \< 75 x 10\^3/l.
* Abnormal hepatic function evidenced by ALT and AST value \>2.5 UNL
* Subjects with any other malignant disease that can affect the bone.
* Subjects with any other non malignant disease that can jeopardize the evaluation of the primary objectives of this trial (severe osteoporosis) or that do not aloud perform the trial evaluations.
* Known hypersensibility to zoledronic acid or other bisphosphonates.
* Subjects that in the investigator's opinion can not cooperate with the protocol.

Other protocol inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Evaluate the effects of Zometa® (Zoledronic Acid) i.v in doses of 4mg for measure the following parameters of efficacy: Quality of Life, Incidence of Events related to the skeleton
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03418246: Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement
Official title: Gingival Health Around Cervical Carious Lesions Restored With Calcium Silicate Based Cement (Biodentine) Compared With Glass-ionomer Cement: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Keywords: gingiva
plaque
pocket depth
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line (Glass Ionomer). The second group will be treated with Biodentine that will be placed near the gum line.
Primary purpose: TREATMENT

Brief summary: This study will test if applying calcium silicate cements (Biodentine) to restore cervical carious lesions might adversely affect the gingival health in comparison with conventionally used tooth colored material (GIC)

Detailed description: The study will compare two different dental materials on dental lesions near the gum line. . The study will determine if one material is more effective in gingival health, after the placement of the two different dental materials.The oral hygiene and the gingival health of the restored teeth will be evaluated clinically at 1, 3 and 6-month intervals.

Eligibility criteria: Inclusion Criteria:

1. good general health;
2. good oral hygiene; and
3. age range 18-60 years old.

Patients with the following criteria were excluded:

1. current smokers;
2. pregnant females;
3. or patient with periodontal diseases; and
4. those who had a history of poorly controlled diabetes, liver disease, malignancy, radiotherapy.

Exclusion Criteria:

1. Pregnant women
2. Patients taking benzodiazepines, narcotics and multiple antidepressants for pain management not associated with the oral cavity
3. Patients requiring treatment for more than 5 decayed sites, periodontal disease and root canal therapy
4. Complicated medical history (\>4 concurrent treatment for systemic diseases)
5. Lesion \>1mm below the gum line

Primary outcomes:
measure: Changes in Gingival index around Cervical Carious Lesions Restored with Calcium Silicate Based Cement (Biodentine™) Compared with Glass-Ionomer Cement;
timeFrame: 6 months
measure: Changes in Plaque accumulation around Cervical Carious Lesions Restored with Calcium
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Pocket Depth around Cervical Carious Lesions Restored with Calcium
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: JUST
name: Rola Al Habashneh, ABP
role: STUDY_DIRECTOR
References:
Clinical trial NCT00577746: Clinical Impact of EUS in Staging NSCLC
Official title: The Clinical Impact of Endoscopic Ultrasound (EUS) in Staging Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung
Keywords: Non Small Cell Lung
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Richard L. Roudebush VA Medical Center
First posted: 2007-12-20
Enrollment: 110
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: Potentially resectable lung cancer subjects see at thoracic oncology clinics and gastroenterolgy lab.

Brief summary: The goal of this prospective study is to determine the clinical and economic impact of endoscopic ultrasound (EUS) in staging NSCLC. Aims: 1) Determine the accuracy of EUS in staging NSCLC 2) Measure 5-year survival 3) Measure quality of life in patients that undergo surgery 4) Determine the cost benefit of EUS in staging NSCLC.


Eligibility criteria: Inclusion Criteria:

* Any subject with presumed or known potentially resectable NSCLC
* Due to the nature of NSCLC, children (\<18 year of age) will not be considered
* Men, women, and minorities
* Subjects must be able to safely undergo conscious sedation for the EUS procedure
* Subjects must be surgical candidates
* Subjects must not have an uncorrectable coagulopathy and must be able to refrain from the used of aspirin one week prior to the EUS
* Patient must provide signed written informed consent

Exclusion Criteria:

* Subjects with a history of previously treated lung, head \& neck, or esophageal cancer are not eligible if the histologic cell type is determined to be the same as what is biopsied during the EUS-FNA
* Uncorrectable coagulopathy
* Significant co-morbidities such as uncontrolled heart failure, or severe chronic obstructive pulmonary disease (COPD) that would limit their survivability to surgery
* Evidence of significant active infection (e.g. pneumonia, peritonitis, wound abscess)
* Evidence of serious ongoing illness such as uncontrolled metabolic disease (diabetes mellitus, hypothyroidism, etc.) or cardiac condition
* Evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric illness that would preclude adequate compliance with this protocol

Primary outcomes:
measure: Determine the accuracy of EUS in staging NSCLC
timeFrame: at the end of the study
Secondary outcomes:
measure: Measure 5-year survival
timeFrame: 5 years
measure: Determine the cost benefit of EUS in staging NSCLC
timeFrame: at the end of the study
measure: Measure quality of life in patients that undergo surgery
timeFrame: at the end of the study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Medical Center; Clarian Health
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Julia LeBlanc, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798846: Fixation of Comminuted Distal Radius Fracture
Official title: Spanning Plate Versus Spanning External Fixator in Fixation of Comminuted Distal Radius Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Keywords: distal radius fracture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparison between different methods in fixation of comminuted distal radius fractures

Detailed description: This clinical study aims at comparison of treatment outcomes of Spanning plate versus spanning External fixator in fixation of comminuted distal radius fracture.

The primary outcomes that we like to measure are pain, healing. Stiffness and range of motion .

Eligibility criteria: * Inclusion criteria

  * Skeletally mature patients aging 18 or more
  * Comminuted distal radius fractures Fernandez type V
* Exclusion criteria

  * Age less than 18 year or more
  * Patients with previous fracture affecting wrist joint in the same side.
  * Parients with active infection in the affected joint
  * Pathological fracture
  * Neurological disorder (epilepsy...etc) Reheumatoid

Primary outcomes:
measure: Mayo modified wrist score
timeFrame: up to 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT02012946: Levosimendan Versus Dobutamine in Cardiopatic Patients Undergoing Major Non Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2013-12-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study wants to investigate the hemodynamic changes in cardiopatic patients undergoing major non cardiac surgery, during and after the continuous infusion of levosimendan or dobutamine.


Eligibility criteria: Inclusion Criteria:

* EF \< 40%, no liver and renal disfynction, chronic cardiopathy

Exclusion Criteria:

* acute coronary syndrome, life expectation \<30 days, hemodialysis, ventricular tachycardia/ventricular fibrillation

Primary outcomes:
measure: cardiac index
timeFrame: 1-3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Francesco Pugliese
Study officials:
References:
Clinical trial NCT01881646: Postoperative Neuroinflammation and Cognitive Dysfunction After Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Surgery
Neurogenic Inflammation
Cognitive Disorders
Keywords: Neuroinflammation
Postoperative cognitive dysfunction
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2013-06-19
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to assess the induction of neuroinflammation in brain regions of interest for learning and memory in adult patients undergoing urological surgery under general anesthesia

Detailed description: The investigators aim to study immune cell activation as a biomarker for neuroinflammation using the cell specific \[11C\]PBR28 probe as detected by PET imaging techniques.

Eligibility criteria: Inclusion Criteria:

1. Patients 60-75 years of age. American Society for Anesthesiologist' criteria (ASA) physical status I-III
2. Lower abdominal surgery (hysterectomy/prostatectomy) under general anaesthesia
3. Obtained consent within 3 months before execution of the study.

Exclusion Criteria:

1. Patient's refusal to participate in the trial
2. Ongoing smoking, snuff or other nicotine compound treatment
3. Disabling neuropsychiatrical disorder (a Mini mental State Examination (MMSE) score ≤ 24, diagnosis of dementia, Mb Alzheimer, Mb Parkinson, schizophrenia, or mental depression) or other signs of significant cognitive decline.
4. History of stroke with neurological sequelae
5. Surgical procedure scheduled for regional anaesthesia.
6. Severe cardia and/or renal and/or hepatic impairment.
7. Coagulopathy.
8. Terminal phase of a chronic disease.
9. Patient on steroidal or non-steroidal anti-inflammatory drugs.
10. Admission B-Glucose \> 15 mmol/litre or poorly controlled diabetes mellitus.
11. Presumed uncooperativeness or legal incapacity.
12. Preoperative or later postoperative B-hemoglobin \< 90 g/L.

Primary outcomes:
measure: Binding of the PET probe [11C]PBR28
timeFrame: Preoperatively, once at postoperative day 2-5 and after 3 month
Secondary outcomes:
measure: Cognitive testing
timeFrame: Preoperatively and after 3 month
measure: Inflammatory biomarkers
timeFrame: Preoperatively, once at postoperative day 2-5 and after 3 month, i.e. at the same time as the PET investigation
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital and Karolinska Institutet
name: Lars I Eriksson, MD,PhD, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06621446: The Beijing Adult Dry Eye Cohort Study
Official title: The Beijing Adult Dry Eye Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dry Eye
Keywords: Prevalence
Incidence
Risk Factor
Dry Eye
Adult
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a population-based study. Study population are residents (adults aged above 18) of sampled communities.

Brief summary: To investigate the prevalence of dry eye in adults in Beijing, and explore the extremely dangerous factors of dry eye in adults in Beijing through two years follow-up, and establish a prediction model of dry eye; On this basis, the prevention and treatment strategy of dry eye disease suitable for Chinese people is put forward, and its actual effect is verified.

Detailed description: Specifically, it is planned to carry out cluster random sampling in Jianguomen community, Yongdingmenwai community, and Jiaodaokou community in Dongcheng District, Beijing, and select adults over the age of 18 to enter the queue for observation; In order to ensure the accuracy of the prevalence survey, people with mobility difficulties or mental problems are not excluded. The subjects will be examined by ophthalmology and OSDI questionnaire to determine whether these people have dry eyes. Then the prevalence of dry eye would be expolored. Then through one-year and two-year follow-up, the incidence would be explored.

Eligibility criteria: Inclusion Criteria:

* Aged 18 or above, resident population of sample community, able to complete dry eye examination, informed consent signed

Exclusion Criteria:

* Mental illness, mobility difficulties, can not participate in follow-up

Primary outcomes:
measure: Incidence of Dry eye
timeFrame: two years
Secondary outcomes:
measure: Prevalence of Dry Eye
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing
state: Beijing
Study officials:
References:
Clinical trial NCT03957746: Set Volume of Optimal Resistance Exercise to Generate Hypotension
Official title: Set Volume of Optimal Resistance Exercise to Generate Hypotension in Hypertensive Elderly Subjects: a Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Post-Exercise Hypotension
Resistance Training
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 19
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the volume of optimal resistance exercise to generate postexercise hypotension after performing a single exercise in hypertensive elderly subjects. 20 subjects will perform 1 control session and 3 resistance training sessions with different volume: 3, 6 and 9 sets


Eligibility criteria: Inclusion Criteria:

* Hypertensive subjects treated with antihypertensive medication
* Controlled blood pressure
* Age between 55 and 70 years old
* Sedentary (less than 150 minutes per week of moderate physical activity and/or 75 minutes per week of vigorous physical activity)
* Non-smokers
* Non-alcoholics
* Informed consent

Exclusion Criteria:

* Any kidney, lung, neurological or psychiatric disease
* Unable to perform exercises
* Participation in other physical activity programs during the study or in the previous 3 months

Primary outcomes:
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: Immediately after the end of resistance training session
measure: Blood pressure
timeFrame: 30 minutes after the end of resistance training session
measure: Blood pressure
timeFrame: 60 minutes after the end of resistance training session
measure: Blood pressure
timeFrame: 4 hours after the end of resistance training session
measure: Blood pressure
timeFrame: 5 hours after the end of resistance training session
measure: Blood pressure
timeFrame: 6 hours after the end of resistance training session
Secondary outcomes:
measure: Heart rate
timeFrame: Baseline
measure: Heart rate
timeFrame: Immediately after the end of resistance training session
measure: Heart rate
timeFrame: 30 minutes after the end of resistance training session
measure: Heart rate
timeFrame: 60 minutes after the end of resistance training session
measure: Heart rate
timeFrame: 4 hours after the end of resistance training session
measure: Heart rate
timeFrame: 5 hours after the end of resistance training session
measure: Heart rate
timeFrame: 6 hours after the end of resistance training session
Other outcomes:
Locations:
city: Rocafort
country: Spain
facility: Primary Health-Care Center
state: Valencia
Study officials:
affiliation: University of Valencia
name: Jose Casaña
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquín Calatayud
role: STUDY_CHAIR
affiliation: University of Valencia
name: Alba Cuerda
role: STUDY_CHAIR
References:
Clinical trial NCT06898346: Ghana MHL Project, Tamale
Official title: Maternal Health, Literacy and Pregnancy Outcomes: the Role of Specialized Nutrition Education
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: Maternal Health Literacy
Dietary Diversity
Nutrition Education
RCT
Ghana
Nutrition Knowledge
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: Nestlé Foundation
First posted: 2025-03-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test a nutrition education program that focuses on local foods in northern Ghana. The goal is to help pregnant women eat a wider variety of foods, increase their intake of protein, energy, and iron-rich foods, and support healthy weight gain during pregnancy. We want to understand how this program impacts mothers' knowledge about nutrition and health, and how it affects the health of their babies. The program was created with input from pregnant women and health professionals in the community.


Eligibility criteria: Inclusion Criteria:

* Nulliparous pregnant (first-time) mothers (BMI\<20kg/m2) between the ages of 18 and 40 attending antenatal sessions and in their second trimester, gestational ages (GA) of 16 weeks to 20 weeks, who are not carrying multiple fetuses

Exclusion Criteria:

* Women with pregnancies greater than 20 weeks gestation, to ensure adequate exposure to the intervention; mothers presenting with significant morbidity or who are admitted due to complications and mothers who cannot confirm an address or contact information and do not plan to deliver at a health facility as well as those who indicate that they would not deliver in the study region (those who will be out of town at time of delivery).

Primary outcomes:
measure: Health Literacy
timeFrame: 10-12 weeks
measure: Dietary Diversity in Women
timeFrame: 15-17 weeks
Secondary outcomes:
measure: Nutrition Knowledge
timeFrame: 15-17 weeks
measure: Infant birth weight
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Tamale
country: Ghana
facility: Tamale Teaching Hospital
state: Northern Region
Study officials:
affiliation: Yale University
name: Ruthfirst EA Ayande, PhD, MSc, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ghana
name: Gloria E Otoo, PhD
role: PRINCIPAL_INVESTIGATOR
References: