louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04083937: Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Official title: Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 897
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As the most common male carcinoma, prostate cancer is a major tumor entity in oncology. In addition to definitive radiotherapy, surgical procedure is considered to be an oncologically equivalent therapeutic alternative for non-metastatic malignancies in the primary setting. However, a subsequent radiotherapy of the prostate bed is often necessary, which takes place as an "adjuvant" treatment immediately after surgery or in the course of a repeated increase in PSA and usually extends over several weeks. For the primary situation (without previous surgery), several randomized phase III clinical trials have shown that it is possible to shorten radiotherapy by increasing the single dose (called hypofractionation). In the context of two prospective Phase II studies, which were carried out in Heidelberg, it has since been shown that hypofractionation with both photons and protons is safe and feasible even in the postoperative situation.

The current, prospective and randomized PAROS study is now intended to demonstrate a multicentric phase III study as an improvement in the quality of life caused by rectum toxicity (primary endpoint) by the use of protons. The oncological non-inferiority of hypofractionated radiotherapy after surgery is a secondary endpoint.


Eligibility criteria: Inclusion Criteria:

* histology-proven prostate cancer with Gleason Score and PSA-value;
* indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
* Karnofsky-Index ≥ 70%
* age ≥ 18 years

Exclusion Criteria:

* androgen deprivation therapy
* lymphatic spread
* macroscopic tumor/ R2
* stage IV (M1)
* previous irradiation

Primary outcomes:
measure: Quality of life (prostate-associated, 12 weeks vs baseline)
timeFrame: 12 weeks
Secondary outcomes:
measure: biochemical progression-free survival (bPFS)
timeFrame: 5 years after baseline
measure: overall survival (OS)
timeFrame: 5 years after baseline
measure: Toxicity acc. to NCI CTCAE V 5.0 after 2 and 5 years
timeFrame: 2 and 5 years after baseline
measure: Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)
timeFrame: 2 and 5 years after baseline
measure: Quality of life (general and prostate-associated, 2 years and 5 years vs. baseline)
timeFrame: 2 and 5 years after baseline
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
Study officials:
affiliation: University Hospital Heidelberg
name: Juergen Debus
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02990637: The Effect of Olive Leaf Extract Administration on Cardiovascular Health
Official title: The Effect of Olive Leaf Extract Administration on Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Elevated Cholesterol
Keywords: Olive leaf extract
Cardiovascular health
Cholesterol
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of daily supplementation of OLECOL for a period of 8 weeks on cardiovascular risk markers.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals
* Age between 18 and 70 years
* Total cholesterol levels ≥ 5.0 mmol/L
* BMI 25-35 kg/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (e.g. cholesterol lowering medication, hypertension medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (\> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (\> 3 kg in previous 3 months)
* High physical activity (\>4.5 hours of running/week)
* History of any side effects towards intake of olives

Primary outcomes:
measure: Blood lipid profile
timeFrame: 8 weeks
Secondary outcomes:
measure: Lipid peroxidation
timeFrame: 8 weeks
measure: Glucose metabolism
timeFrame: 8 weeks
measure: Systolic and diastolic blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht University Medical Center
name: Ad Masclee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stevens Y, Winkens B, Jonkers D, Masclee A. The effect of olive leaf extract on cardiovascular health markers: a randomized placebo-controlled clinical trial. Eur J Nutr. 2021 Jun;60(4):2111-2120. doi: 10.1007/s00394-020-02397-9. Epub 2020 Oct 9.
Clinical trial NCT07010237: Dose-attenuated IST and Hetrombopag in Elderly (≥65 Years) Patients With Severe Aplastic Anemia
Official title: Dose-attenuated IST and Hetrombopag in the Treatment of Elderly (≥65 Years) Patients With Very Severe/Severe Aplastic Anemia: A Single-Center, Single-Arm, Phase IIB Clinical Study on Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sever Aplastic Anaemia
Elderly (People Aged 65 or More)
Immunosuppressive Treatment
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 65
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospetive,Single-Center, Single-Arm, Phase IIB Clinical Study.This study aims to evaluate the efficacy and safety of dose-attenuated IST combined with Hetrombopag in elderly patients (≥65 years) with VSAA/SAA.

Detailed description: Design : Prospective, single-center, single-arm, open-label Phase IIB trial.

Intervention :

P-ATG : 15 mg/kg/day IV ×5 days. Cyclosporine : 3 mg/kg/day (adjusted to trough 100-200 μg/L). Hetrombopag : 15 mg daily. Follow-Up : Weekly for 24 weeks, with bone marrow evaluation at 24 weeks.

Inclusion Criteria :

Confirmed diagnosis of VSAA/SAA. Age ≥65 years. Completion of all screening assessments. Ability to swallow oral medication. Signed informed consent (by patient or legal guardian if patient is incapacitated).

Exclusion Criteria :

Clonal cytogenetic abnormalities (excluding isolated -Y or +8). Prior treatment with ATG/high-dose cyclophosphamide. Prior cyclosporine/tacrolimus use \>12 months. Prior TPO-RA therapy \>3 months. Uncontrolled malignancies or conditions contraindicating ATG. Severe organ dysfunction (e.g., creatinine ≥177 μmol/L). Investigator judgment of unsuitability.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of VSAA/SAA.
* Age ≥65 years.
* Completion of all screening assessments.
* Must be able to swallow tablets.
* Signed informed consent (by patient or legal guardian if patient is incapacitated).

Exclusion Criteria:

* Clonal cytogenetic abnormalities (excluding isolated -Y or +8).
* Prior treatment with ATG/high-dose cyclophosphamide.
* Prior cyclosporine/tacrolimus use \>12 months.
* Prior TPO-RA therapy \>3 months.
* Uncontrolled malignancies or conditions contraindicating ATG.
* Severe organ dysfunction (e.g., creatinine ≥177 μmol/L).
* Investigator judgment of unsuitability.

Primary outcomes:
measure: Hematologic response rate at 24 weeks post-ATG treatment.
timeFrame: 24 weeks
Secondary outcomes:
measure: Early mortality rate
timeFrame: 12 weeks
measure: Complete Response
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Red Blood Cell Diseases Center
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Diseases Hospital, CAMS
name: Jun Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02032537: Efficacy of Calmmax Cream in the Management of Chronic Uremic Pruritus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Calmmax Cream on UP in CKD Patients.
Keywords: callmax cream
uremic pruritus
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Uraemic pruritus (UP) remains a frequent and distressing problem in patients with advanced chronic kidney disease (CKD) and end-stage renal disease (ESRD).

Calmmax is a new topical cream that was introduced recently by Calmmax Pharma, an Israeli pharmaceutical company developed a topical cream based on active plant extracts for treatment of skin inflammation. We intend to conduct a prospective, double blind, placebo controlled, randomized trial that will assess the therapeutic effect of Calmmax cream on UP in a cohort of CKD and ESRD patients.


Eligibility criteria: Inclusion Criteria:

1. History of pruritus of \>8 weeks duration.
2. Severity score of pruritus ≥5 as defined by VAS
3. Discontinuation of any medication with presumed antipruritic effects at least 1 week before the study (including Calmmax cream)
4. Negative pregnancy test result for all participating women of childbearing age;

Exclusion Criteria:

1. Known allergy to Calmmax cream
2. Any acute illness
3. Liver cirrhosis
4. Active dermatological disorder other than UP
5. Decompensated heart failure
6. Inability to give informed consent
7. Known poor adherence to medical recommendations

Primary outcomes:
measure: Improvement of UP measured by reduction of VAS by more than 50 percent from baseline score
timeFrame: 1 year
Secondary outcomes:
measure: quality of life assessed by questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Itzchak Slotki, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT01832337: Limb Remote Ischemic Preconditioning for Heart and Intestinal Protection During Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparoscopic Colorectal Surgery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators hypothesized that limb remote ischemic preconditioning (RIPC) would reduce heart and gastrointestinal function injury in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.


Eligibility criteria: Inclusion Criteria:

* age \>40 years old
* ASA I-II
* receive elective laparoscopic colorectal surgery
* written informed consent can be obtained

Exclusion Criteria:

* coagulation disorders
* patients with cardiac pacemaker
* patients with severe cardiac,or pulmonary,hepatic,renal disease ,or can not tolerate laparoscopic surgery
* patients with peripheral vascular disease affecting the upper limbs
* patients with mental,or hearing, vision disorder, who is not able to communicate with physicians
* difficult airways that can not receive rapid induction

Primary outcomes:
measure: Limb remote ischemic preconditioning may have effective protection of heart and intestinal in middle-aged and elderly patients undergoing elective laparoscopic colorectal surgery.
timeFrame: within the first 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00607737: Applications Site Reactions After Injection of Insulin Detemir and Saline in Subjects With Diabetes
Official title: Doubleblind, Randomised, Single Centre Investigator Sponsored Study of Applications Site Reactions After Deep and Superficial Subcutaneous and Intradermal Injection of Insulin Detemir and Saline in Subjects With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2008-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: To compare application site reactions after superficial and deep subcutaneous and intradermal injections of insulin detemir and saline in patients with diabetes

- The patient serves as his own control, n=100 patients with diabetes


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus
* HbA1c\<11 %
* BMI: 20-35 kg/m2
* Insulin detemir naive
* Basal insulin dose\>20E

Exclusion Criteria:

* Known allergy to study drug
* Current steroid or antiallergic treatment
* Lipodystrophy
* Change in insulin and antihypertensive treatment \< 30 days
* Smokers or alcoholics

Primary outcomes:
measure: laser doppler blood flow
timeFrame: 10 minutes - 7 days
Secondary outcomes:
measure: clinical signs
timeFrame: 10 min - 7 days
measure: insulin detemir specific antibodies
timeFrame: 3 months
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: LIse Tarnow, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968837: The Kilimanjaro Cervical Screening Project
Official title: The Kilimanjaro Cervical Screening Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Cervical Neoplasms
Cervical Cancer
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Kilimanjaro Christian Medical Centre, Tanzania
First posted: 2013-10-24
Enrollment: 1072
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Although highly curable, cervical cancer kills thousands of women in developing countries annually. The investigators will pilot a project to improve detection of cervical cancer in Kilimanjaro, Tanzania through a program that combines access to cervical screening expertise available in a large medical centre and remote use of a mobile phone camera application.


Eligibility criteria: Inclusion Criteria:

* Female
* Over 18 years of age

Exclusion Criteria:

* Previous removal of uterus

Primary outcomes:
measure: Test accuracy of using digital smart phone cervicograms in place of traditional cervicography images produced through traditional SLR cameras
timeFrame: 3 months
Secondary outcomes:
measure: Measure accuracy and feasibility of non-physician healthcare workers ability to obtain adequate cervical images via smart phone camera photographs.
timeFrame: 3 months
Other outcomes:
measure: Measure accuracy, quality, and feasibility of SMS text messaging of cervical images obtained by smart phone in place of traditional transfer methods for digital cervical images.
timeFrame: 3 months
Locations:
city: Moshi
country: Tanzania
facility: Reproductive Health Centre, KCMC
Study officials:
affiliation: Queen's University
name: Karen Yeates, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03080337: Group vs. Traditional Diabetes Prenatal Care
Official title: Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pregnancy
Diabetes
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Akron Children's Hospital
First posted: 2017-03-15
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.


Eligibility criteria: Inclusion Criteria:

* Clinically confirmed viable pregnancy at the time of enrollment.
* Able to provide consent for participation.
* Diabetes diagnosed prior to 12 weeks gestation.
* Initiation of care by 20 weeks gestation.
* Age 18 years or older.

Exclusion Criteria:

* Not planning to deliver at UnityPoint Health- Meriter Hospital.

Primary outcomes:
measure: Compliance with glucose testing over time
timeFrame: 2 years
Secondary outcomes:
measure: Maternal Weight Gain (kilograms)
timeFrame: 2 years
measure: Length of stay for delivery (days)
timeFrame: 2 years
measure: Presence of infection (Y/N)
timeFrame: 2 years
measure: Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)
timeFrame: 2 years
measure: Blood Pressure (mm Hg)
timeFrame: 2 years
measure: Neonatal Birth Weight (grams)
timeFrame: 2 years
measure: Neonatal Length of stay (days)
timeFrame: 2 years
measure: Neonatal APGAR Score (0-10)
timeFrame: 2 years
measure: Gestational Age at Delivery (weeks)
timeFrame: 2 years
measure: Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)
timeFrame: 2 years
measure: Patient and care giver satisfaction (survey)
timeFrame: 2 years
measure: Cost-effectiveness (dollars per hour)
timeFrame: 2 years
Other outcomes:
Locations:
city: Madison
country: United States
facility: UnityPoint Health- Meriter Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kara Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00919737: Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme
Official title: A Phase 1/2, Multicenter, Non-Randomized, Open Label Clinical Trial of NPC-08 Implant in Patients Undergoing Surgery for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Malignant Glioma
Keywords: NPC-08
carmustine
nitrosourea
safety
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged between 18 and 65 years;
* Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
* Karnofsky Performance Score of 60 or higher;
* Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;

Exclusion Criteria:

* More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
* Prior radiotherapy to the brain;
* Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
* Known hypersensitivity to nitrosoureas;
* Participation in any other investigational protocol in the previous 6 months for any type of malignancy;

Primary outcomes:
measure: Overall survival to 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: The Tazuke Kofukai Foundation Medical Research Kitano Hospital
Study officials:
affiliation: Saitama International Medical Center, Saitama Medical University
name: Masao Mastutani, M.D., D.M.Sci.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02371837: Effects of Pilates in Risk Fall in Older Population
Official title: Effects of 6 Week of Pilates in Fall Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falling Injury
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2015-02-26
Enrollment: 103
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The intervention will consist in a 6 week of pilates practice in older population to check the prevention of fall effectiveness.

Detailed description: A study population of elder people will be randomly allocated to intervention or control group, consisted in Pilates and a booklet of balance tips respectively.

The protocol will be performed for 6 weeks.

Eligibility criteria: Inclusion Criteria: - Elder population. Not to be a pilates practitioner previous to study enrollment. Exclusion Criteria: - Cognitive issues that dont allow to practice pilates method.

Sensorial alteration or any disease that could altered balance. Any drug or medication that modify balance.

Primary outcomes:
measure: Change in Falls Efficacy Scale International test (FES I)
timeFrame: pre intervention and post 6 weeks of intervention
Secondary outcomes:
measure: Change in Star Excursion Balance Test (SEBT)
timeFrame: pre intervention and post 6 weeks of intervention
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: University of Jaén
state: Andalucia
Study officials:
affiliation: IBIMER University of Granada
name: Antonio Martinez, PhD
role: PRINCIPAL_INVESTIGATOR
References: