louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03972371: The ProVerum First in Man PROVE Study
Official title: The ProVerum First in Man PROVE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: ProVerum Medical
Sponsor class: INDUSTRY
First posted: 2019-06-03
Enrollment: 10
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomised, single centre, safety and feasibility study
Primary purpose: TREATMENT

Brief summary: A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).


Eligibility criteria: Inclusion Criteria:

* Males ≥ 50 years of age
* Moderate-to-severe symptomatic BPH
* IPSS of \> 15
* Peak urinary flow rate (Qmax) of \<12 mL/s
* Prostate volume of ≥ 30 and ≤80 cc
* Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

* A prostatic urethral length of less than 4cm
* A prostatic volume \<30cc or \>80cc
* An obstructing intravesical prostatic median lobe
* Urinary incontinence due to an incompetent external sphincter
* Urethral pathologies that may prevent insertion of delivery system
* A current symptomatic urinary tract infection
* Current significant visible haematuria
* Patients with known allergy to nickel or titanium
* History of significant medical co-morbidity or prior surgery that may confound the results of the Study
* Another medical condition that would pose an unacceptable patient risk
* Known or suspected urological condition that may affected voiding function
* Neurogenic bladder and/or sphincter abnormalities
* Patients with cognitive disabilities unable to understand and give informed consent to the research study

Primary outcomes:
measure: Deployment of the Implant
timeFrame: Immediately after the implant deployment procedure
measure: Expansion of the Implant
timeFrame: Within 24 hours of the implant deployment procedure
Secondary outcomes:
measure: Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period
timeFrame: Immediately after the implant deployment procedure, within 24 hours
measure: Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years
timeFrame: 2 years
measure: Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms
timeFrame: 2 years
measure: Preliminary assessment of the effectiveness of the procedure in improving urinary flow
timeFrame: 2 years
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
Study officials:
References:
Clinical trial NCT02242071: Cell Therapy for Motor Neuron Disease/Amyotrophic Lateral Sclerosis
Official title: The Effect of Autologous Bone Marrow Mononuclear Cell Transplantation on Motor Neuron Disease/Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Autologous Mononuclear Cell therapy
Stem cells
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effect of autologous bone marrow mononuclear cells on Motor Neuron Disease/Amyotrophic Lateral Sclerosis patients.


Eligibility criteria: Inclusion Criteria:

* Patients with the diagnosis of definite Motor Neuron Disease/amyotrophic lateral sclerosis.
* Age 18-80 years

Exclusion Criteria:

* HIV/HBV/HCV
* Malignancies
* Bleeding tendencies
* Pneumonia
* Renal failure
* Severe liver dysfunction
* Severe anemia \[hb \< 8\]
* Any bone marrow disorder
* Space occupying lesion in brain
* Pregnancy and lactation
* Other acute medical conditions/infections such as respiratory infection and pyrexia
* left ventricular ejection fraction \< 25%
* Patient on artificial ventilatory support

Primary outcomes:
measure: Amyotrophic Lateral Sclerosis Functional rating scale-revised
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
Clinical trial NCT02899871: Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease
Official title: Joint Pain Occurring During Anti-TNF Therapy in Chronic Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: joint pain
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IBD (Crohn's disease or ulcerative colitis),

Brief summary: IBD (inflammatory bowel disease) are associated with various types of joint manifestations, especially inflammatory. Patients with IBD treated with anti-TNF commonly report joint symptoms, with variable expressions and aetiologies, possibly responsible for impaired quality of life, and possibly leading to discontinuation of an effective and validated treatment.


Eligibility criteria: Inclusion Criteria:

* Males or females over the age of 18 years at the time of inclusion
* Patients with IBD (Crohn's disease or ulcerative colitis), diagnosed by a set of compatible clinical (chronic diarrhoea, haematochezia, anoperineal lesions, etc.), laboratory, histological and endoscopic arguments. Patients will be included regardless of the severity of their disease, its clinical course, the type of lesions, and the presence or absence of associated manifestations.
* Patients treated with anti-TNF: infliximab or adalimumab.
* Informed patients not refusing to participate.
* Patients covered by French national health insurance.

Exclusion Criteria:

* Patients under the age of 18 years at the time of inclusion.
* Patients previously treated with anti-TNF, but no longer treated with anti-TNF at the time of inclusion.
* Protected majors (under permanent or temporary guardianship).

Primary outcomes:
measure: Diagnosis of joint pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Jean-Louis DUPAS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06612671: Treatment Outcomes of Retroperitoneal Sarcoma
Official title: Prognostic Factors and Oncological Outcome Analysis of Retroperitoneal Sarcoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Retroperitoneal Sarcoma
Keywords: Retroperitoneal Sarcoma
Surgery
Radiotherapy
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital. The preoperative procedure including angiography or TAE, radiotherapy is allowed.

Brief summary: Investigators tried condult a retrospective study to analysis the prognostic factors and oncological outcome analysis of Retroperitoneal Sarcoma treated in our high volume medical center.

Detailed description: Retroperitoneal Sarcoma (RPS) which is a rare disease which incidence is 1.79/100,000. The treatment is difficult to due to it anatomy position which often invade to multiple organs and cause the complete surgical resection to be very complex and difficult. It was known to sacrifice one side kidney will improve the resection rate. To this days, successful surgical resection was still the gold standard that provide most benefit in overall survival. To reach that goal, pre-operative radiotherapy was applied to RPS which intended to achieve similar effect in rectal cancer for the down staging effect and improved the respectability but with limited benefit. Herein, investigators conducted this study to find the best way to achieve successful surgical resection and prognostic factor analysis.

Eligibility criteria: Inclusion Criteria:

* the patient who have retroperitoneal maliganacy and receive complete tumor excision in our hospital

Exclusion Criteria:

* the patient did not receive complete tumor excision in our hospital
* the pathological report yielded not malignancy tumor

Primary outcomes:
measure: Overall survival
timeFrame: The proportion of patients still alive at 1 year, 3 years, and 5 years after treatment.
Secondary outcomes:
measure: Progression free survival
timeFrame: The rates of local recurrence, regional recurrence, or distant metastasis at 1 year, 3 years, and 5 years after treatment.
Other outcomes:
measure: The resectability of preoperative embolization
timeFrame: From the start of preoperative evaluations to the day of surgery, it typically spans 7 days.
measure: The value of eGFR in renal function
timeFrame: Period from date before surgery to the date one year after suregry
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Department of Radiation-Oncology, Taichung Veterans General Hospital
name: Radiation-Oncology Department Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00445471: A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development Disorders, Pervasive
Keywords: Autism Spectrum Disorder
Autistic Disorder
Pervasive Developmental Disorder
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-03-09
Enrollment: 45
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as usual. A child and adolescent psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental psychologist will make the developmental and psychological assessments using the Vineland Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before the child enters the study. Each child will be reassessed following completion of the Mifne intervention, at three and at six months after commencement of treatment. The control child will also be reassessed at three and at six months after commencement of a therapeutic intervention.


Eligibility criteria: Inclusion Criteria:

* All children between the ages of 2-5 years who meet diagnostic criteria for Autism or Pervasive Developmental Disorder by DSM IV criteria who are referred for treatment at Mifne for the treatment group.
* The control group will consist of children meeting the same criteria who are referred to Schneider Children's Medical Center of Israel (SCMCI). Matching will be for age, sex, ethnicity, socioeconomic status, IQ, language development and diagnosis.

Exclusion criteria:

* All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.

Primary outcomes:
measure: ADOS scores at 3 and 6 months after commencement of treatment
timeFrame: 2.5 years
Secondary outcomes:
measure: CGI-I score after 3 and 6 months
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
Study officials:
affiliation: Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
name: Alan Apter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00498771: Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Official title: Aquatic Exercise Study for Breast Cancer Patients With Lymphedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Keywords: Lymphedema
Aquatic Exercise
Breast Cancer
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2007-07-10
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine what effects aquatic exercise has on participants with Lymphedema.

Detailed description: This pilot study will examine the effectiveness of aquatic exercise in reducing Lymphedema. The study is designed for breast cancer patients who have developed Lymphedema following cancer treatment. Potential study participants should have explored conventional treatments such as decongestive therapy and lymph drainage massage before joining the study.

There are two groups that the participants may choose from until enrollment for the group has reached its capacity.The active arm of the study will attend 12 one-hour aquatic exercise classes and classes will be held in an indoor heated pool. There is no cost to the participants.Both the active arm and the control group (not attending aquatic exercise classes) will have 3 measurement assessments that will compare the circumference and volumetric measurement of arms, as well as height, weight and body mass index (BMI).

Both group will fill out a program questionnaire. Quality of life survey taken at baseline, week 6, month 6 and 12 will be compared. A follow up questionnaire will be completed at 6 and 12 month intervals, and annually for five years.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients with Lymphedema
* Patients must have received standard Lymphedema treatment (Complete Decongestive Therapy) prior to participating in the study.
* Patients undergoing treatment will require written permission from their physician
* Complete an assessment by a licensed physical therapist before beginning the exercise program
* Patients must sign a consent form to participate

Exclusion Criteria:

* Patients undergoing treatment without physician's written permission
* Patients with health problems that contraindicate exercise
* Patients are not eligible if the physical therapy assessment identifies a contraindication to participation

Inclusion of Women and Minorities:

- Men, women and minorities with breast cancer related lymphedema are eligible

Primary outcomes:
measure: Reduction of Lymphedema
timeFrame: baseline, week 6, month 6, and month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor Sammons Breast Center
state: Texas
Study officials:
affiliation: Baylor Sammons Breast Center
name: Michael Grant, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00272571: The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells
Official title: The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: ECPT, endothelial progenitor cells
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-01-06
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of the study are to test the hypothesis that external counter pulsation therapy (ECPT) provides clinical benefit by improving the number and function of endothelial progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.

Detailed description: ECPT is a non-invasive approach for increasing blood flow to the heart in patients with myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD) patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute to neoangiogenesis.

We prospectively study CAD patients \[Canadian Cardiovascular Society (CCS) angina class II-IV\], before and after ECPT , and compare them with age- and sex-matched controls. Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using high-resolution ultrasound.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* CCS angina class II-IV

Exclusion Criteria:

* aortic regurgitation
* acute myocardial infarction \<3 months
* systemic hypertension \>180/110 mm
* atrial fibrillation
* deep vein thrombosis
* phlebitis and hemorrhagic diathesis
* pregnancy
* abdominal aortic aneurism
* metastatic tumor

Primary outcomes:
measure: The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)
Secondary outcomes:
measure: Brachial artery endothelial function (before and one week after treatment)
measure: CCS angina class (before and one week after treatment)
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Neufeld cardiac research institute, Sheba medical center
Study officials:
affiliation: Chaim Sheba Medical Center
name: Jonathan Leor, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810571: Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study
Official title: Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: erector spina plane block
quadratus lumborum block
patient controlled analgesia
nephrectomy
analgesia
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Detailed description: patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continious remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.

Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* open nephrectomy elective patients
* BMI\<35

Exclusion Criteria:

* ASA 4-5-6
* Laparoscopic nephrectomy
* infection at the block side
* coagulation disorder
* BMI\>35

Primary outcomes:
measure: postoperative morphine consumption
timeFrame: 24 hour postoperatively
Secondary outcomes:
measure: peroperative remifentanil consumptions
timeFrame: 4 hour preoperatively
measure: numeric rating scale
timeFrame: 24 hour postoperatively
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
References:
Clinical trial NCT05410171: Machine Learning-based Early Clinical Warning of High-risk Patients
Official title: Machine Learning-based Early Clinical Warning of High-risk Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-risk Patients
Risk Reduction
Machine Learning
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Through the early warning platform for inpatients established by our hospital, the various indicators of patients collected in real time are carried out for automated intelligent evaluation and analysis, early warning of high-risk patients to assess the impact on patient prognosis and the impact on the occurrence of adverse events in inpatients.

Detailed description: Build the early warning system.

Eligibility criteria: Inclusion Criteria:

1. Patients who use ECG monitoring
2. Age ≥ 18 years old
3. Understand and sign an informed consent form

Exclusion Criteria:

* Pregnancy or lactation

Primary outcomes:
measure: 28-day all cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: Hospital mortality
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital, Southeast University, China
name: Songqiao Liu, PhD.
role: PRINCIPAL_INVESTIGATOR
References: