louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05406063: Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases
Official title: Stereotactic Multiple Fraction Radiotherapy for Non-spine Bone Metastases a Multicentre Prospective, Open Label, Randomised Controlled Phase 3 Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Therapy
Bone Metastases
Pain
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
Collaborators: name: Krebsforschung Schweiz, Bern, Switzerland
First posted: 2022-06-06
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate, whether multi-fraction stereotactic body radiation therapy (SBRT) within 3 treatment fractions is non-inferior to the current standard of care of 5 fraction SBRT regarding pain response at 3 months after radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Personally signed and dated written informed consent,
* Histological diagnosis of malignancy,
* Histologically or radiologically diagnosed bone metastasis,
* Age ≥ 18 years
* Pain or under pain control medication

Exclusion Criteria:

* Pregnant or lactating women,
* Women of childbearing potential or sexually active males not willing to use effective contraception while on treatment and 3 months after the end of treatment,
* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.,
* Prior radiotherapy to the intended treatment site,
* Lesions \> 5cm in maximum diameter,
* Prior treatment with radioactive isotopes within 30 days of randomisation,
* Spinal column, hands, feet, or head as intended treatment site,- Fracture at the intended treatment site,
* Surgery required or previous surgery at the intended treatment site
* Instability of the intended treatment site.

Primary outcomes:
measure: Pain relief (response rate) measured with the Visual Analog Scale (VAS) from Baseline to 3 months after treatment.
timeFrame: Baseline and 3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Kanton Zürich
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Robert Foerster, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04945863: COVID-19 in Nursing Homes 2020 and 2021
Official title: Association Between COVID-19 Vaccination and Reduced Mortality in Nursing Home Facilities.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comorbidities and Coexisting Conditions
Frailty
Covid19
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
Collaborators: name: Region Östergötland
First posted: 2021-06-30
Enrollment: 258
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Residents in nursing homes in Östergötland County Council, Sweden

Brief summary: To describe the effect on mortality in nursing home facilities during three separate equally long periods during the pandemic and more specifically to analyse the effect on mortality of improved preventive routines and vaccination.

Detailed description: Retrospective descriptive cohort study in Östergötland County Council, Sweden comprising 136 nursing home facilities with a possibility to host 4500 residents. All residents in any of these NHs who had a laboratory confirmed COVID-19 diagnosis between March 2020 to April 2021 and who died within 30 days after the verified diagnosis are included. The study is undertaken as a retrospective record review. From the records patient-level data on demographic variables, clinical signs, comorbidity, performance status, and cause of death are collected.

Eligibility criteria: Inclusion Criteria:

* All residents in any of 136 nursing homes in Östergötland County Council, Sweden who had a laboratory confirmed COVID-19 diagnosis and who died within 30 days after the verified COVID-19 were included in three separate periods: First period from March 31 to June 30 2020; second period from October 15 2020 to January 15 2021; third period from January 16 to April 18 2021.

Exclusion Criteria:

-

Primary outcomes:
measure: Comorbidity
timeFrame: March 2020 to April 2021
measure: Frailty
timeFrame: March 2020 to April 2021
measure: Cause of death
timeFrame: March 2020 to April 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Anestesi- och operationskliniken, Universitetssjukhuset
Study officials:
References:
Clinical trial NCT00497263: End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Diverticulitis
Lead sponsor: Niti Medical Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2007-07-06
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis


Eligibility criteria: Inclusion Criteria:

* Patient age over 18
* Patient schedule for colonic surgery requiring E-t-E anastomosis
* Patient is able to understand and to sign the Informed Consent Form

Exclusion Criteria:

* Patient has known allergy to Nickel
* Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
* Patient on regular steroid medication
* Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
* Patient following radiation (that compromised the anastomosis)
* Patient who are undergoing a defunctioning stoma
* Patient with contraindication to general anesthesia
* Patient who is currently participating in other clinical trial
* Patient who refuse consent

Primary outcomes:
measure: functioning anastomosis & no occurrence of adverse events related to device use
timeFrame: during hospitalization and until 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Gasthuisberg Leuven
state: Brabant
Study officials:
affiliation: University Hospitals Gasthuisberg Leuven
name: André D'Hoore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06135935: Postprandial Glucose Response Using Mass-Market No-Added-Sugar Ice Cream
Official title: Postprandial Glycaemic Changes When Patients With Type 2 Diabetes Consume the New KDD Products
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
no added sugar-flavored ice cream
conventional ice cream
postprandial glycemic response
Lead sponsor: Dasman Diabetes Institute
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In this double blind randomized controlled cross over design trial, patients will be randomized to receiving new KDD product or analog first. On the subsequent visit the opposite product will be provided.
Primary purpose: SCREENING

Brief summary: KDD is developing a new line of no-added-sugar products in line with its metabolic reengineering initiative and its metabolic matrix. The recipes fundamentally do not alter total saturated fat or protein levels and mainly offer the benefit of no added sugar and a significant reduction in net carbohydrates as well glycaemic index.

Detailed description: The consumption of highly ultra-processed foods has been identified as having detrimental effects on human metabolic health, leading to various adverse health outcomes. The Metabolic Matrix represents a highly quantified, science-based tool for reengineering products with the aim of promoting positive metabolic outcomes. This approach may also contribute to creating shared value by solving important social problems such as obesity and type 2 diabetes by scalable products that are profitable.

KDD is committed to addressing the pandemic of metabolic diseases in Kuwait and would like to develop products that benefit the collective metabolic health of the Kuwait population. KDD is working with partners to assist in its ground-breaking work and to support its efforts with a strong evidence-base rooted in leading-edge science in metabolic health and nutrition. We hypothesise that no-added sugar-flavored ice cream have a substantially different postprandial glycaemic response compared to conventional products in patients with type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

1. Type 2 diabetes
2. Aged over 18 years
3. HbA1c 6.5-8.5% (48-69 mmol/L)

Exclusion Criteria:

1. Lactose intolerant
2. Not liking chocolate ice cream

Primary outcomes:
measure: The primary outcome will be area under curve for the plasma glucose response over 120 minutes after consumption of the ice creams.
timeFrame: 8 months
Secondary outcomes:
measure: Plasma insulin responses over 120 minutes after consumption of the ice creams.
timeFrame: 8 months
measure: CGM monitor readouts over 24 hours after consumption of the ice creams.
timeFrame: 8 months
Other outcomes:
Locations:
city: Kuwait City
country: Kuwait
facility: Ebaa Al Ozairi
state: Dasman
Study officials:
affiliation: Dasman Diabetes Institute
name: Ebaa Al Ozairi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01644435: A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring
Official title: A Prospective, Multicentric, Open Label, Bio Interventional, Phase I, Phase II Pilot Study to Evaluate the Safety and Efficacy of Autologous Human Platelet Lysate (HPL) for Treatment of Acne Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: ACNE SCARRING
Lead sponsor: Kasiak Research Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2012-07-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.


Eligibility criteria: Inclusion Criteria:

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
* Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects with active infection or active acne.
* Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders.
* Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
* Subjects who have received prior chemotherapy and radiotherapy
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days

Primary outcomes:
measure: Changes in the Global Acne scarring classification
timeFrame: Day 0, End of study - Month 3
Secondary outcomes:
measure: Photographic Assessment
timeFrame: Day 0, Month 1, Month 2 End of study - Month 3
Other outcomes:
measure: Physician's assessment scores
timeFrame: End of Study - Month 3
measure: Patient's assessment scores
timeFrame: End of Study - Month 3
Locations:
city: Thane
country: India
facility: Kasiak Research Pvt Ltd
state: Maharashtra
Study officials:
affiliation: Dermocosmetic laser center hair and skin clinic
name: Sharmila Patil, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radiance Cosmetology Clinique
name: Pankaj Maniar, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315235: The Peripheral Mobilized Mononuclear Cell-based Therapy in Patient With Diabetic Neuropathy
Official title: The Efficacy and Safety of Peripheral Mobilized Mononuclear Cell-based Therapy in Patients With Diabetic Painful Neuropathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetic Neuropathy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of autologous peripheral blood stem cell based therapy in patients with diabetic painful neuropathy.

Detailed description: Diabetic painful neuropathy a prevalent, disabling disorder. Currently, the only effective treatments are glucose control and pain management. Diabetic neuropathy is characterized by reduction of vascularity in peripheral nerves and deficiency in neurotrophic and angiogenic factors. Recent studies have shown that bone marrow (BM)-derived stem or progenitor cells have favorable effects on the repair of cardiovascular diseases. Since these BM-derived stem or progenitor cells contain various angiogenic and neurotrophic factors, these cells have been attempted for treating experimental diabetic neuropathy, and turned out to be effective for reversing various manifestations of experimental diabetic neuropathy.

However, stem-cell therapy was not proven in human study. Therefore, we will investigate the efficacy and safety of autologous peripheral blood stem cell injection in diabetic neuropathy.

Eligibility criteria: Inclusion Criteria:

* symptomatic diabetic neuropathy moderate pain more than 3 months Michigan Neuropathy Screening Instrument (MNSI) \>3 3/day mean pain scale \> NRS 4 Body weight \>50 kg systolic blood pressure: 90-150 mmHg, Diastolic blood pressure \<100 mmHg, Body temperature \<37.5℃, Pulse rate: 50-100/min

Exclusion Criteria:

* other cause of neuropathy symptomatic peripheral vessel disease skin lesion or arthritis central neuronal disease drug addiction or abuse Aspartate aminotransferase or Alanine aminotransferase \>1.5 times than upper normal limit range Creatinine clearance rate \<60ml/min or dialysis Myocardial infarction, unstable angina or heart failure diagnosed in 3 months psychologic disorder pregnancy or lactation

Primary outcomes:
measure: Changes in pain for a week after the procedure
timeFrame: baseline, 4 week, 12 week
Secondary outcomes:
measure: The evaluation of changes in the specific neuro-sensory system
timeFrame: baseline, 4 week, 12 week
Other outcomes:
measure: The secondary effect of the procedure for the peripheral nerves and blood vessels
timeFrame: baseline, 12 week
Locations:
city: Seoul
country: Korea, Republic of
facility: SeoulNUH
Study officials:
affiliation: Seoul Nation University Hospital
name: Hye Seung Jung, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02407535: Assessing Uterine Ultrasound Done as a Diagnostic Tool for the Depth of Carcinoma Invasion
Official title: Assessing the Ultrasound Done on a the Uterus After Hysterectomy as a Diagnostic Tool for the Depth of Endometrial Carcinoma Invasion Into the Myometrium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Endometroid Carcinoma
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study the investigators aim to assess the diagnostic performance of intraoperative, ultrasonographic assessment of the surgical extracted uterus for determining myometrial invasion's depth in comparison to preoperative ultrasound, intraoperative gross inspection and final pathological report (gold standard). The investigators hope that intraoperative gross inspection of the extracted uterus might offer an additional intraoperative tool for assessing the need for pelvic lymphadenectomy in early stage of endometrial cancer at least as good as pathological exam.


Eligibility criteria: Inclusion Criteria:

1. Patient's age is 18 or above
2. Patient has been scheduled to undergo hysterectomy (laparoscopic or abdominal) for the staging and treatment of endometrial cancer (endometrioid subtype) and with the relevant suspected symptoms.
3. Patient able to understand,read and sign informed consent.
4. Patient is not participating in other medical trials at present or in the past 30 days

Exclusion Criteria:

1. Age under 18 years
2. Patients assessed preoperatively to be at stage 2 and higher endometrial carcinoma
3. Subjects which their biopsy in the pre operating process will include high risk cell types:

   * Grade 3 endometrioid adenocarcinoma,
   * clear cell carcinoma
   * papillary serous carcinoma
   * carcinosarcoma

Primary outcomes:
measure: Tumor invasion
timeFrame: Average of 2 weeks (immediate assessment by ultrasound, average of 2 weeks for final pathological report)
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Ido Feferkorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02185235: A Randomized Controlled Trial of Electrical Stimulation to Treat Pelvic Floor Disorder
Official title: To Evaluate The Efficacy of Electrical Stimulation and Biofeedback Treatment for Pelvic Floor Disorder Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Incontinence
Keywords: Electrical stimulation
Biofeedback
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2014-07-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Female pelvic floor disorders (PFDs) include urinary incontinence,pelvic organ prolapse (POP), and fecal incontinence-which often occur together.

Pelvic floor disorders impair multiple aspects of the life quality, including the sexual function of women.

Surgery became the first choice of treatment, however, and not until 1980s was the renewed interest in conservative therapies.

This may be because of higher awareness among women and cost of and morbidity after surgery.

The conservative treatment included pelvic floor muscle training, electrical stimulation, vaginal cones, and biofeedback.

The outcome was up to 35\~70 % improved rate as the literature before. Current guidelines recommended conservative management as a first-line therapy. However, there was no consistent consensus on this issue due to variations in stimulation parameters、adjuvant concurrent modality or duration of treatment course, and insufficient result about large and long term follow up of randomized- controlled studies.

Therefore, the investigators try to conduct one randomized-controlled trial to evaluate the efficacy of conservative treatment for Pelvic floor disorder (Pelvic organ prolapse, urinary incontinence, chronic pelvic pain etc.).

At the aspect of Quality of life, our studies tried to focus on the different domains of pelvic disorder and sexual quality by means of validated questionnaire more objectively.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from pelvic organ prolapse and/or urinary incontinence and/or fecal incontinence.

Exclusion Criteria:

* Patient is pregnant The patient had any major medical or psychiatric disease The patient with Metabolic medical device

Primary outcomes:
measure: 1-Hour Pad test of urine leakage amount (gm)
timeFrame: Total 18 times of treatment, for 3 months
Secondary outcomes:
measure: Quality of life (score)
timeFrame: Total 18 times of treatment, for 3 months
Other outcomes:
measure: Vaginal pressure (mmHg)
timeFrame: Total 18 times of treatment, for 3 months
measure: Urodynamics data analysis
timeFrame: Total 18 times of treatment, for 3 months
Locations:
city: Taipei
country: Taiwan
facility: Taiwan, Taipei, Mackay Memorial hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: TSUNG H Su, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02590835: Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients
Official title: Efficiency of Piezocision-assisted Orthodontic Treatment in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Overcrowding
Keywords: Adult patients
Patient demand for orthodontic treatment
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed as a randomized controlled clinical trial to compare conventional orthodontic treatment (control group) and piezocision-assisted orthodontic treatment (PS group). Twenty-four consecutive adult patients from the Orthodontics Department of Liege University Hospital, Belgium who met the inclusion criteria were enrolled from January to October of 2013.


Eligibility criteria: Inclusion Criteria:

* Adult patients (completed growth)
* Maxillary and mandibular overcrowding
* Patient demand for orthodontic treatment
* Adequate dento-oral health
* ASA I and ASA II
* Compliance with clinic visits every 2 weeks

Exclusion Criteria:

* A need for tooth extraction
* A need for orthodontic temporary anchorage devices
* A history of periodontal disease
* Smokers
* Altered bone metabolism (e.g., due to anti-resorptive drug, steroid or immunosuppressant use)
* Mental or motor disabilities
* Pregnancy

Primary outcomes:
measure: Overall treatment time measurement (in days)
timeFrame: 3 years
Secondary outcomes:
measure: Root resorption parameters measurements (intrabuccal radiographic in millimeters)
timeFrame: 3 years
measure: Comparaison of periodontal parameters between the test group and the control group before (at baseline) and after orthodontic treatment.
timeFrame: 3 years
measure: Patient-centered outcomes (VAS questionnaire)
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
citation: Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.