louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00969202: Stereotactic Hypofractionated Radiosurgery for Early Stage Prostate Cancer
Official title: Phase 1 Study of Stereotactic Hypofractionated Radiosurgery of Low Grade Prostate Cancer/Early Stage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Cancer of the Prostate
Prostate Tumor
Novalis Tx
Novalis
Stereotactic Radiosurgery
Radiosurgery
Radiation
Lead sponsor: San Diego Radiosurgery
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate a short course of very focused (stereotactic) external beam radiation therapy for the treatment of early stage prostate cancer.

The investigators will gather scientific information about the tolerance and side effects this type of radiation. The investigators will then compare these results with those of standard 8 week course of external beam radiation therapy to see if this study treatment is equally or more effective in treating prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate
* Gleason score ≤ 6 and low volume Gleason 7 (3+4)
* PSA \< 10
* Clinical Stage of T2a or less
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Prior radiation treatment for prostate cancer
* Gleason score \> 7
* PSA \> 10
* Clinical Stage of T2b or greater

Primary outcomes:
measure: PSA decline measured through laboratory testing.
timeFrame: One month following radiosurgery through 5 year follow up
Secondary outcomes:
measure: Quality of life in relation to urinary, bowel and sexual function. Measured through a questionnaire at each follow up visit.
timeFrame: One month following radiosurgery through 5 years follow up.
Other outcomes:
Locations:
city: Escondido
country: United States
facility: San Diego Radiosurgery at Palomar Medical Center
state: California
Study officials:
affiliation: San Diego Radiosurgery/X-Ray Medical Group-Radiation Oncology
name: P. Brian Volpp, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02319902: Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy
Official title: The Effects of Using Heated Humidified Carbon Dioxide Gas on Post Operative Pain Scores, Nausea and Analgesic Requirements in Patients Undergoing Gynaecological Laparoscopy: a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
* Capacity to consent

Exclusion Criteria:

* Patients unable to speak English
* Patients unable to give consent

Primary outcomes:
measure: Shoulder tip pain
timeFrame: 8 hours
Secondary outcomes:
measure: General abdominal pain, nausea, vomiting and analgesia requirements
timeFrame: 8 hours
measure: Shoulder tip pain, general abdominal pain, nausea, vomiting.
timeFrame: 7 days
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: Royal Surrey County Hospital NHS Trust
state: Surrey
Study officials:
References:
Clinical trial NCT02963402: Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
Official title: Analysis of Immunoregulatory Mechanisms of Treg Cells Induced by Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis,Rheumatoid
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AR patients treated with tocilizumab in monotherapy or treated with adalimumab as control.

Brief summary: We can speculate that the best responders to tocilizumab should have multiple related elements (Treg CD39, adenosine, IL-35) successfully induced and expressed in order to play its beneficial role. The study of these elements and its pathways could help identify the best responders to tocilizumab treatment.


Eligibility criteria: Inclusion Criteria:

* Patients of all sexes, aged ≥ 18 years.
* RA Patients (according to ACR / EULAR criteria 2010) of moderate to severe activity (DAS 28\> 3.2 or SDAI\> 11), and 6 months or more of evolution, starting treatment with ACTEMRA (tocilizumab) or with an anti-TNF, according to the product data.
* Patients with body weight ≤ 150 kg.
* Patients who have received written information about the study and gave their informed consent to participate in the study

Exclusion Criteria:

* Patients with a history of autoimmune disease or inflammatory joint disease other than RA.
* Patients treated with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is greater) before starting treatment with tocilizumab

Primary outcomes:
measure: Treg phenotype
timeFrame: Baseline to 6 months change
measure: ATP (adenosine triphosphate)
timeFrame: Baseline to 6 months change
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Insitut de Recerca Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT00574002: Establishing Safe Drainage Limits for Pleural Chest Tube Removal.
Official title: Defining the Threshold for Safe Chest Tube Removal.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thoracic Surgery
Thoracic Trauma
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 0
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: Surgery patients

Brief summary: The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.

Detailed description: Measurement of pleural fluid drainage in chest tubes of trauma patients.

Eligibility criteria: Inclusion Criteria:

* Presence of at least one chest tube
* No air leak present
* Fluid is not infected
* Pleural drainage of fluid was an indication for placement of the chest tube
* Patient is post-thoracic surgery
* Patient is post-thoracic trauma
* Informed consent obtained

Exclusion Criteria:

* Presence of air leak
* Infected pleural fluid
* Active intra-thoracic bleeding
* Thoracic empyema
* Non-removal of chest tube (i.e.: expired)
* Pregnancy
* Less than 18 years of age
* Unable to obtain informed consent

Primary outcomes:
measure: Repeat chest tube insertion within 30 days
timeFrame: two years
measure: Thoracotomy on affected side within 30 days
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Truman Medical Center
state: Missouri
Study officials:
affiliation: Truman Medical Center
name: Gerald L. Early, M.D., M.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674502: Safety of ADU-1604 in Adults With Metastatic Melanoma
Official title: A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ADU-1604, an Anti-CTLA-4 Antibody, in Adults With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Metastatic Melanoma
Lead sponsor: Aduro Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study
Primary purpose: TREATMENT

Brief summary: This study is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, PK, and PD of ADU-1604 and explore initial clinical activity in adults with metastatic melanoma.

Detailed description: ADU-CL-17 is a first-in-human, open-label, multicenter, dose-escalation study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ADU-1604, an anti-CTLA-4 monoclonal antibody, and explore initial clinical activity in adults with metastatic melanoma. The primary objective of the study is to determine the Recommended Phase 2 Dose (RP2D) of ADU-1604 administered by IV infusion once every 3 weeks for 4 doses.

The study will be conducted in two parts: Dose Escalation followed by Dose Confirmation.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged ≥18 years
2. Histologically-confirmed metastatic or unresectable melanoma
3. Progression of disease following at least one prior therapy, and is not a candidate for, or is intolerant to, established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted). Subjects must have BRAF mutation status confirmed; if a subject is BRAF V600E/K positive, they must have received a BRAF- targeted regimen prior to entering the study, unless the patient was deemed ineligible for such treatment
4. Measurable disease according to RECIST (v1.1) \[NOT required during Dose Escalation\]
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

1. Prior diagnosis of uveal or mucosal melanoma
2. Prior treatment with CTLA-4-directed therapy in the metastatic setting. Use of CTLA- 4-directed treatment in the adjuvant or neoadjuvant setting is acceptable provided the last dose was \>6 months before the first dose of ADU-1604 and there was no discontinuation of treatment due to a treatment-related toxicity.

Primary outcomes:
measure: Identify the recommended P2 dose (RP2D) of ADU-1604 administered as an IV infusion
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital de la Timone
city: Paris
country: France
facility: Hospital Saint Louis
city: Villejuif
country: France
facility: Gustave- Roussy Institute
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
References:
Clinical trial NCT02439502: EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Official title: Single Center, Prospective, Open Label Post Marketing Study of EndoChoice's Fuse® Endoscopic System Performance In Routine Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Miscellaneous Gastroenterology and Urology Devices Associated With Adverse Incidents, Not Elsewhere Classified
Lead sponsor: EndoChoice Innovation Center, Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The intent of this study is to evaluate the performance and usability of Fuse in routine practice. The participants are indicated for upper (gastroscopy) and lower (colonoscopy) gastrointestinal endoscopy procedures. The study is open label, prospective and Post Marketing study.

Detailed description: The intent of this study is to evaluate the performance and usability of Fuse in routine practice EndoChoice's Fuse system - Fuse is an FDA, CE and AMAR approved Endoscopic system (Gastroscope and Colonoscope).

Fuse® system The Fuse system is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse system consists of camera heads, endoscopes, video system, light source and other ancillary equipment.

Fuse Colonoscopes in conjunction with the FuseBox™ processor are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult subjects.

Fuse Gastroscopes in conjunction with the FuseBox™ processor are indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

Eligibility criteria: Inclusion Criteria:

* Male and female subjects ages 18 at least
* The subject has been scheduled for routine screening upper or lower endoscopy, diagnostic work up, or endoscopic surveillance.
* Signed informed consent

Exclusion Criteria:

* Subjects who are currently enrolled in another clinical study

Primary outcomes:
measure: Number of findings (abnormal GI findings, such as polyps and tec.) per diagnostic procedure, using Fuse® system
timeFrame: 1 outpatient hospitalization day for subject
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Carmel Medical Center, Haifa, Israel.
name: Jacob Dickstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862602: Pedometers for Gestational Diabetes
Official title: Type 2 Diabetes Risk in Women With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: GDM
gestational diabetes
pregnancy
diabetes
walking
exercise
pedometer
online
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-03-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ten to 50% of women with gestational diabetes (GDM), or glucose intolerance first recognized during pregnancy, develop diabetes within 5 years after delivery. Although intensive interventions can reduce diabetes incidence in women with impaired glucose tolerance, it is unknown if such strategies would be effective in women with GDM. Women with recent GDM, even though no longer pregnant, face significant barriers to lifestyle modification, including caregiving responsibilities and low perception of risk. Web-based programs can reinforce physical activity through visual feedback of pedometer output, tailored messaging, education, and on-line communities. Such a program is currently available for adults with chronic disease and is led by Dr. Richardson, a co-PI on this application. Using data from focus group and survey work conducted by Dr. Kim, the other co-PI, this program can be modified to women with recent GDM. For Specific Aim 1, we propose to adapt a chronic disease web-based pedometer program to women with recent GDM. For Specific Aim 2, we propose to conduct a pilot and feasibility study of the program. The intervention will last 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Gestational diabetes diagnosis within past three years
* Access to computer with internet, USB port and Windows XP or Vista
* Regular email user (weekly or more)
* Can walk a block on her own
* Sedentary (less than 150 minutes purposeful physical activity per week)

Exclusion Criteria:

* Pregnancy
* Unable to consent legally

Primary outcomes:
measure: Weight loss
timeFrame: Pre-post
measure: Glucose tolerance
timeFrame: Pre-Post
Secondary outcomes:
measure: Hemoglobin A1c
timeFrame: Pre-post
measure: Step counts
timeFrame: Pre-Post
measure: Insulin
timeFrame: Pre-post
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Catherine Kim, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05711602: The Physical and Mental Health of People With Type II Diabetes Mellitus.
Official title: Influence of the Pilates Method on the Physical and Mental Health of People With Type II Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult ALL
Diabete Type 2
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief summary: To analyze the effects of a Pilates exercise program on physical and mental health in people with type II diabetes mellitus.

Detailed description: This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

* A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* Not participating in an exercise program
* That they were able to carry out the different selected questionnaires.

Exclusion Criteria:

* Contraindications for performing physical tests
* Illnesses that limit static and dynamic balance and physical activity
* Central or peripheral vestibular or nervous disorders.

Primary outcomes:
measure: Dynamometer
timeFrame: Up to twelve weeks
measure: Blood Glucose Concentration
timeFrame: Up to twelve weeks
measure: BMI (Body Mass Index)
timeFrame: Up to twelve weeks
measure: TUG (Timed Up and Go test)
timeFrame: Up to twelve weeks
measure: Chair sit and reach test
timeFrame: Up to twelve weeks
measure: Back scratch test
timeFrame: Up to twelve weeks
measure: Height
timeFrame: Up to twelve weeks
measure: BBS (the Berg Balance Scale)
timeFrame: Up to twelve weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jaén
country: Spain
facility: U.E.D. Virgen de la Capilla
Study officials:
References:
Clinical trial NCT02241902: Impact of Postoperative Pyuria on Treatment Outcomes After PVP
Official title: Does Postoperative Pyuria Influence Treatment Outcomes After Photoselective Vaporization of the Prostate (PVP)?: A Short-term Serial Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Hyperplasia
Pyuria
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment

Brief summary: The aim of this study was to identify serial changes in the incidence of postoperative pyuria after the Photoselective Vaporization of the Prostate (PVP), to determine whether the presence of postoperative pyuria could be correlated with surgical outcomes after surgery and to identify predicting factors that influence on persistent pyuria after the PVP.


Eligibility criteria: Inclusion Criteria:

* men who underwent photoselective vaporization (PVP) using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment
* sterile urine on urinalysis and urine culture before surgery
* absence of indwelling urethral catheter before surgery

Exclusion Criteria:

* previous diagnosis of prostate carcinoma or bladder cancer
* co-existence of urinary stone
* any antibiotic treatment within 2-weeks before surgery

Primary outcomes:
measure: Change in the subtotal storage symptoms score of the International Prostate Symptom Score (IPSS)
timeFrame: 1-week, and 1-, 3- and 6-months after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University ilsan Hospital
state: Gyeonggi-do
Study officials:
affiliation: DongGuk University
name: Min Chul Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03770702: Statins and ARBs on Rheumatoid Activity
Official title: Investigational and Comparative Study Between the Anti-inflammatory Effectof Both Angiotensin Reeptor Blockers and Statins on Rheumatoid Arthritis Disease Activity on Egyptian Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigational and comparative study between the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

Detailed description: The study aims at ivestigating and comparing the anti-inflammatory effectof both angiotensin reeptor blockers and statins on rheumatoid arthritis disease activity on Egyptian patients

Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis.

Exclusion Criteria:

* Pregnant or lactating
* Hepatic or renal impairment.

Primary outcomes:
measure: Change in disease activity score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Head of Clinical Pharmacy Department
name: Sahar K Hegazy, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Prof of Clinical Pharmacy
name: Tarek M Mostafa, Prof
role: STUDY_DIRECTOR
affiliation: Rheumatology Dept. - Menoufia University
name: Emad M Elshebini, MD
role: STUDY_CHAIR
affiliation: Clinical pharmacy Department-Tanta University
name: Ahmed HM El-Abd, Msc
role: STUDY_CHAIR
References: