louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02410044: Prospective PRO/QoL Registry for Patients With Bone Metastases of Breast or Prostate Cancer
Official title: Open-labeled, Multicenter, Non-interventional Prospective PRO/QoL Registry for Patients With Osteoprotective Treatment for Bone Metastases of Breast or Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Prostate Cancer
Bone Metastases
Keywords: Patient Reported Outcomes
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2015-04-07
Enrollment: 500
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 metastasized breast or prostate cancer at the start of first systemic osteoprotective treatment for bone metastases

Brief summary: Evaluation of patient reported outcomes (PRO) / QoL regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

Detailed description: The PRO Bone project will recruit a representative cohort of patients with breast or prostate cancer suffering from bone metastases. The aim of this study is to collect data on Patient Reported Outcomes (PRO)/Quality of Life regarding bone pain and the impact of bone pain on quality of life and daily activities. PROs are assessed by a questionnaire consisting of a visual analog scale for bone pain, two questions regarding bone pain management, the bone pain module of FACT questionnaire (FACT-BP) and four questions addressing the impact of treatment on daily life (overall, social life, ability to work and ability to perform routine tasks)

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic breast or prostate cancer
* Start of first systemic osteoprotective treatment
* Ability to read and understand German
* Written informed consent

Exclusion Criteria:

• None

Primary outcomes:
measure: Patient Reported Outcomes (PRO) regarding bone pain and the impact of bone pain on quality of life and daily activities in patients with bone metastases treated with osteoprotective agents.
timeFrame: 12 months
Secondary outcomes:
measure: Patient Reported Outcomes regarding the impact of treatment on daily life
timeFrame: 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
facility: Multiple sites all over Germany
Study officials:
affiliation: medical practise for oncology
name: Mark-Oliver Zahn, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00963144: Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study
Official title: Diagnosis and Response to Treatment Using a Reliable Gerd Questionnaire-an In Clinical Practise Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Gerd Questionnaire
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-08-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.


Eligibility criteria: Inclusion Criteria:

* Patients of either gender aged between 18-79 years of age
* Patients must be having symptoms of gastroesophageal reflux disease

Exclusion Criteria:

* None

Primary outcomes:
measure: To determine the applicability and utility of Gerd Q in the diagnosis of GERD and assessment of treatment response
timeFrame: The applicability and utility of the Gerd Questionnaire will be done on 2 vists- Day 1 and Day 30
Secondary outcomes:
measure: To assess and monitor the treatment response of patients diagnosed with GERD
timeFrame: The monitoring and assessment of treatment response using the Gerd Questionnaire will be done on 2 vists-Day 1 and Day 30
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
Study officials:
affiliation: Faculty of Medicine, University of Malaya Medical Center (UMMC),
name: Goh Khean Lee, MBBS, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00896844: A Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health
Official title: A Randomised Controlled Trial on the Effect of Emotional Disclosure of Traumatic Life Events on Physical Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: emotional disclosure
expressive writing
students
Lead sponsor: University Hospital Birmingham
Sponsor class: OTHER
Collaborators: name: University of Birmingham
First posted: 2009-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled trial on the effect of emotional disclosure of traumatic life events on physical health. The hypothesis is that expression of emotions could possibly improve physical health.


Eligibility criteria: Inclusion Criteria:

* healthy

Exclusion Criteria:

* any mental or physical illnesses in the last three months

Primary outcomes:
measure: health centre visits
timeFrame: within 3 months
Secondary outcomes:
measure: respiratory infections
timeFrame: within 3 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University of Birmingham
state: West Midlands
Study officials:
References:
Clinical trial NCT01234844: The Relationship Between Pet Therapy and "Well-being" in Geriatric Rehabilitation In-patients
Official title: The Relationship Between Pet Therapy and "Well Being" in Geriatric Rehabilitation In-patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Hip Fracture
Keywords: pet-therapy
guinea-pigs
rehabilitation
elderly
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In -patients in a geriatric rehabilitation unit, will participate in structured therapy with guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of their rehabilitation.

Detailed description: Measurement of anxiety before and after pet therapy using standardized questionaire.

Eligibility criteria: Inclusion Criteria:

willingness to touch the pets,-

Exclusion Criteria:

blindness,deafness,aphasia, lack of knowledge of hebrew language,allergy or phobia to animals.MMSE less than 21,duration of admission lessthan two weeks.-

Primary outcomes:
measure: The relationship between pet-therapy and "well-being"among geriatric rehabilitation in-patients
timeFrame: two weeks
Secondary outcomes:
measure: anxiety score
timeFrame: two weeks
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Geriatric Department ,Meir Hospital
Study officials:
affiliation: Meir Hospital
name: Devorah T Spiegel, MB.ChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671744: Fetal Cell Analysis From Maternal Blood
Official title: Validation of a Cell-Based Technology for Non-Invasive-Prenatal-Diagnosis (CB-NIPD) Using Circulating Whole Fetal Cells From Maternal Peripheral Blood.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prenatal Screening
Pregnancy Related
Genetic Disease
Lead sponsor: Menarini Biomarkers Singapore
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.


Eligibility criteria: Inclusion Criteria:

* Participant has a viable singleton or twin pregnancy
* Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
* Participant is at least 18 years old and can provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
* Prenatal diagnosis of clinical Chorioamnionitis
* Intake of drugs or exposure to teratogenic agents
* Infections that carry a risk of vertical transmission
* Known maternal viral diseases: HIV and HCV, HBV

Primary outcomes:
measure: Fetal chromosomal abnormalities detection in circulating fetal cells,
timeFrame: 2 year
Secondary outcomes:
measure: Number of suitable fetal cells
timeFrame: 2 year
measure: Fetal sex assessment
timeFrame: 2 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda-Policlinico di Milano Ospedale Maggiore
Study officials:
References:
Clinical trial NCT04103944: A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteonecrosis
Keywords: osteonecrosis
osteonecrotic repair device
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patients will be divided into treatment group (osteonecrotic repair device) or control group (core decompression)
Primary purpose: TREATMENT

Brief summary: Numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients.

Detailed description: Total of 20 patients were enrolled and randomized in this study. There are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.

Eligibility criteria: Inclusion Criteria:

* Skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, CT, or MRI scan
* Patients without any allergies or major systemic or organ diseases
* Patient's affected hip diagnossied as the 3rd stage of ONFH by MRI

Exclusion Criteria:

* Other lower lib fractures
* Pregnancy
* Extensive degenerative arthritis in hip
* Severe osteoporosis in the head and/or neck of the femoral bone
* Rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip
* Stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion
* Diagnosed with either Stage 4, 5, or 6, of ONFH classification by either radiography, MR, CT scan.

Primary outcomes:
measure: Western Ontario and McMAster Universities Osteoartheitis Index (WOMAC)
timeFrame: Baseline before procedure/surgery up to follow up 2 years after
measure: Visual Analogue Scale(VAS)
timeFrame: Baseline before procedure/surgery up to follow up 2 years after
measure: Harris Hip Score (HHS)
timeFrame: Baseline before procedure/surgery up to follow up 2 years after
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00916344: Master Study for the Investigation of Safety and Efficacy of the EVIA Pacemaker
Official title: Master Study of the EVIA DR-T/DR/SR-T/SR Pacemaker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker Indication
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2009-06-09
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to prove the safety and efficacy of the EVIA pacemaker. Primarily, the newly implemented Atrial Capture Control algorithm is evaluated, which automatically measures the right atrial threshold and subsequently adjusts the pacing output.


Eligibility criteria: Inclusion Criteria:

* Meet the indications for pacemaker therapy
* Understand the nature of the procedure
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet none of the pacemaker indications
* Meet one or more of the contraindications
* Patients with chronic atrial fibrillation (dual chamber pacemaker only)
* Have a life expectancy of less than six months
* Cardiac surgery in the next six months
* Enrolled in another cardiac clinical investigation
* Have other medical devices that may interact with the implanted pacemaker

Primary outcomes:
measure: Efficacy of Atrial Capture Control Feature (Automatic Atrial Threshold Test Minus Manual Atrial Measurement)
timeFrame: 1 month follow-up completed
Secondary outcomes:
measure: Complication Free Rate
timeFrame: 1- and 3- month follow-up completed
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU Bordeaux Haut-Lévêque
state: Bordeaux
Study officials:
affiliation: CHU Bordeaux Haut-Lévêque
name: Philippe Ritter, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338544: Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
Official title: Application of Epiduo(R) PUMP in Daily Practice in Patients With Inflammatory Acne
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acne Vulgaris
Lead sponsor: Galderma Laboratorium GmbH
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 1388
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: About 2000 patients aged ≥9 years with moderate to severe inflammatory acne

Brief summary: The purpose of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne.

Detailed description: The objective of this observational trial is to assess application and convenience of Epiduo® PUMP under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. In addition, efficacy of Epiduo® and incidence of adverse events will be assessed under marketed conditions. Also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire.

The observational study is designed as a multicentre study, covering all parts of Germany. Participating investigators are dermatologists with an adequate patient pool of acne patients. The observation time per patient will up to 3 months.

Eligibility criteria: Inclusion Criteria:

* Age ≥9 years
* The patient has been diagnosed with moderate to severe inflammatory acne (Leeds Grade 4-12)
* Chest/back affected allowed, but not required
* Topical therapy of acne with Epiduo® is indicated, the decision about treating the patient with Epiduo® has been made independently from this study

Exclusion Criteria:

* Pregnancy or breastfeeding
* Acne inversa
* Acne with preferential manisfestation of microcysts, macrocysts and macrocomedones
* Hypersensitivity to the medication or any of the ingredients
* Other contraindications mentioned in the Epiduo® SPC

Primary outcomes:
measure: Severity of acne
timeFrame: at baseline and after up to 3 weeks of treatment
Secondary outcomes:
measure: Patient-reported assessment
timeFrame: at follow-up
measure: Physician's assessment
timeFrame: at follow-up
measure: Adherence
timeFrame: at follow-up
measure: Dysmorphic concern
timeFrame: at baseline
measure: Adverse drug reactions
timeFrame: at follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsklinikum Gießen und Marburg GmbH
name: Uwe Gieler, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03842644: Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring
Official title: Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring: a Single Center, Perspective, Randomly, Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scar
Keywords: Tension Reduction
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 55
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.

Detailed description: Primary measurement: the mean scar width calculated by standard photos with rulers.

Secondary measure: the probability of scar hyperplasia.

Eligibility criteria: Inclusion Criteria:

* The incision is not shorter than 3cm
* Skin type is III/IV

Exclusion Criteria:

* Any medical history of facial surgery, not included injection therapy, external medication or fat graft
* Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
* Patients with a history of keloid or family history of keloid
* Patients with serious skin disorders, eg. serious psoriasis or dermatitis
* Patients with severe systemic or congenital disease which may affect the patient's safety in this study

Primary outcomes:
measure: Scar width
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Hypertrophic scar rate
timeFrame: through study completion, an average of 1 year
measure: Patient and observer scar assessment scale score
timeFrame: through study completion, an average of 1 year
measure: Vancouver Scar Scale
timeFrame: through study completion, an average of 1 year
measure: Relative side effect
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Lin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664244: Combination of Nimotuzumab and Radiotherapy for Recurrent Uterine Cervical Squamous Carcinoma
Official title: Combination of Nimotuzumab and Radiotherapy for Recurrent and Metastatic Uterine Cervical Squamous Carcinoma: a Single-arm, Open, Phase 2 Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Cervical Carcinoma
Radiotherapy
Epidermal Growth Factor Receptor
Nimotuzumab
Objective Response Rate
Progression-free Survival
Overall Survival
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible patients will undergo the same treatment.
Primary purpose: TREATMENT

Brief summary: Patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. On the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. This study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor \[EGFR\] IgG1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. The primary endpoint is the objective response rate evaluated by imaging methods. The second endpoints are the progression-free survival and overall survival. The treatment toxicity is regarded as one the second endpoint.


Eligibility criteria: Inclusion Criteria:

* Female aged more than 18 years
* Eastern Cooperative Oncology Group score 0-1
* Pathological confirmed of uterine cervical squamous carcinoma
* An interval of 3 months or more since the fulfilling of last treatment
* At least one measurable lesion defined by Response Evaluation Criteria in Solid Tumors (RECIST) guideline 1.1
* Anticipative survival period of 3 months or more
* Lab testing within reference ranges
* With appropriate contraception
* Provided consents of participating the trial

Exclusion Criteria:

* With a history of exposure to other antiangiogenic agents
* With other malignancies within past 3 years
* With vital complications
* With uncontrolled hypertension despite of medical treatment
* With brain metastasis
* With addiction to psychiatric medications or with mental disorders

Primary outcomes:
measure: Objective response rate
timeFrame: 1 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 3 years
measure: Disease control rate
timeFrame: 1 year
measure: Adverse event rates
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: