louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00018356: Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
Official title: Physiologic Effects of PRMS & Testosterone in the Debilitated Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Weakness
Muscular Atrophy
Keywords: Aging
nutrition
rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 88
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study's primary objective is to determine the independent and combined effects of progressive resistance muscle strength training and testosterone on the development of sustainable improvements in physical function.


Eligibility criteria: Inclusion Criteria:

The study will be limited to those patients who are metabolically stable and free of metastatic cancer and limiting end organ disease. Their total serum testosterone must be less than 480 and PSA less than 10.

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: No. Little Rock
country: United States
facility: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
state: Arkansas
Study officials:
affiliation: Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
name: Dennis Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sullivan DH, Roberson PK, Johnson LE, Bishara O, Evans WJ, Smith ES, Price JA. Effects of muscle strength training and testosterone in frail elderly males. Med Sci Sports Exerc. 2005 Oct;37(10):1664-72. doi: 10.1249/01.mss.0000181840.54860.8b.
Clinical trial NCT02992756: Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques
Official title: Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Low Ovarian Reserve
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-4 oocytes.

Improve the follicular response in patients with low response, increasing the number of follicles in subsequent cycles to treatment with growth factors.


Eligibility criteria: Inclusion Criteria:

1. Patients must give written consent.
2. To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the time of study selection time of selection for the study.
3. Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
4. Patients with low ovarian reserve (AMH \<1.1 ng/mL) according to the Bologna criteria.
5. Patients who are going to undergo IVF/ICSI cycle with low follicular response: who after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected to be obtained at the present time (less than 4 follicles).

   oocytes (less than 4 follicles in the basal ultrasound).
6. To have recent analytical results (haemogram, biochemistry and coagulation); at least 11 months prior to inclusion in the study and a serology, according to clinical practice.

Translated with www.DeepL.com/Translator (free version)

Primary outcomes:
measure: Number of follicles recruited after instability of ovarian growth factors
timeFrame: two months; Time included in two protocols of ovarian stimulation
Secondary outcomes:
measure: Rates of pregnancy rates
timeFrame: three months after embryo transfer after treatment of growth factors
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
Study officials:
References:
Clinical trial NCT03971656: Preoperative Nutritional Intervention in Head and Neck Cancer
Official title: Preoperative Nutritional Intervention in Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Malnutrition
Keywords: Cancer
Surgery
Malnutrition
Preoperative
Nutrition
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of preoperative nutritional supplements on head and neck surgery patients.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 who are seen in the Department of Otolaryngology-Head and Neck Surgery clinic, have a new H\&N cancer diagnosis, and have not undergone previous treatment for H\&N cancer are eligible for this study. We will enroll only patients who will be undergoing primary surgery for their cancer treatment, and those undergoing primary radiation or primary chemoradiation for treatment will be excluded. All eligible patients will undergo nutritional screening using the PG-SGA. Those who screen positive for malnutrition (\>1 on the PG-SGA scale) will be randomized to either our standard care (control) versus nutritional intervention group.

Exclusion Criteria:

* Prior treatment for head and neck cancer. Those undergoing primary radiation or chemoradiation for their head and neck cancer. Vulnerable populations. Patients who screen as well nourished (\>1 on the PG-SGA scale) will be excluded as they do not require nutritional intervention. Patients who screen as severely malnourished (\>8 on the PG-SGA scale) will be excluded as these patients require intervention and should not be potentially randomized to our control arm. Patients requiring nasogastric tube feeding or gastrostomy tube feeding will be excluded. Patients are routinely evaluated by speech pathologist prior to surgery. Those in which there is concern for aspiration will be excluded as they will not be able to participate fully in the intervention.

Primary outcomes:
measure: Change in Scored Patient-Generated Subjective Global Assessment
timeFrame: Baseline and day of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT01471756: Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia
Official title: Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia: A Randomized Prospective Comparison of Snares and Injectate in the Resection of Large Sessile Colonic Polyps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neoplasms
Gastric Cancer
Keywords: sessile neoplasms
flat neoplasms
gastric cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: US Endoscopy
First posted: 2011-11-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

Detailed description: The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.

Eligibility criteria: Inclusion Criteria:

* Sessile colorectal polyp
* laterally spreading lesions as defined by Paris Classification type II and \> 1 cm or greater

Exclusion Criteria:

* Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
* Inflammatory bowel disease patients
* Coagulopathy ( INR\> 1.5) that cannot be corrected

Primary outcomes:
measure: Efficacy of Two Devices used in EMR
timeFrame: 1 year
Secondary outcomes:
measure: Compare the Use of Two Injectates
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Timothy A Woodward, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00854256: Trabeculectomy Versus Canaloplasty to Treat Glaucoma
Official title: Comparison of Canaloplasty and Trabeculectomy in Patients With Open Angle Glaucoma and Inadequate Local Eye Pressure Lowering Therapy - a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: iScience Interventional Corporation
First posted: 2009-03-03
Enrollment: 60
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: The aim of the study is to investigate pressure lowering effect of two surgical methods canaloplasty and trabeculectomy in patients with open angle glaucoma, in which under local pressure lowering therapy the progression of the disease could not be stopped, and thus a pressure lowering surgical intervention is necessary. The risks in the postoperative course in Canaloplasty in the literature as lower than for the trabeculectomy with mitomycin-C. Conversely, large glaucoma centers questioning the effectiveness of permanent pressure lowering of canaloplasty. Precisely this question is investigated in the study.


Eligibility criteria: Inclusion Criteria:

* patients with open angle glaucoma and excavation of 0.4 - 0.8
* 60 eyes of 60 patients (30 patients for trabeculectomy, 30 patients for Canaloplasty) The ratio of female / male is not involved.
* Eye pressure under local therapy: 20mmHg and above (corrected with pachymetry table).
* Local drug therapy: at least 2 eye pressure lowering ingredients or absolute intolerance to preservatives or eye drops.
* general anesthesia possible.
* The operation must be signed by the surgeon as a state-of-the-art performed without complication to be evaluated. If the operation does not meet this criterion, the patient is excluded from the study.

Exclusion Criteria:

* all patients are not included in the group of inclusion criteria, or:
* Phenprocoumon therapy.
* operation is not done state-of-the-art.
* after the surgery: additional eye pressure lowering surgery, cataract surgery, keratoplasty, laser surgery in the anterior eye segment (except suture lysis after trabeculectomy)
* Uveitis, or possible inflammation of the eye
* Previous eye pressure lowering operations or laser interventions
* Corneal Refractive Surgery (pseudophakia allowed)

Primary outcomes:
measure: Eye pressure
timeFrame: Within 12 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Centre of Ophthalmology, University of Cologne
state: NRW
Study officials:
References:
Clinical trial NCT01935856: Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Official title: A Dose Escalation, Single and Multiple Dose, Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hyperparathyroidism
Keywords: patients
receiving
hemodialysis
Secondary
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients receiving hemodialysis


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Stable chronic renal disease patients receiving hemodialysis 3 times weekly for at least 12 weeks prior to the screening
* intact PTH value ≥ 240 pg/mL at the screening
* Corrected serum calcium ≥ 8.4 mg/dL at the screening

Exclusion Criteria:

* Patients with primary hyperparathyroidism
* Patients who received cinacalcet within 2 weeks prior to the screening
* Patients with change in dose or dosing regimen of active vitamin D/ its analogs, phosphate binders and/or calcium containing compounds within 2 weeks prior to the screening
* Patients who received parathyroidectomy and/or parathyroid intervention
* Patients with uncontrolled hypertension and/or diabetes
* Patients with severe heart disorder
* Patients with severe hepatic disease
* Patients who take investigational drug in other clinical trial within 12 weeks prior to the screening
* Patients who have been judged ineligible to participate in the study by the investigator

Primary outcomes:
measure: The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination
timeFrame: For 19 weeks
Secondary outcomes:
measure: Profiles of pharmacokinetics
timeFrame: Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose period
measure: Profiles of pharmacodynamics
timeFrame: For 4-15 days after every dosing
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact Kyowa Hakko Kirin
Study officials:
References:
Clinical trial NCT05777356: Sanitary Napkins for Urinary Assessment of Micronutrients
Official title: Pilot Study: Collection of Urine From Sanitary Napkins for the Analysis of Micronutrient Deficiencies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus: Nutritional Deficiency
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are primarily recruited at the University of Hohenheim

Brief summary: This study aims to find an easy urinary collection method for the assessment of urinary markers of micronutrient status.

Detailed description: Urinary collection in newborns and infants can be difficult. Our study aims to find an easy and cheap alternative to urinary collection bags and specialized pads that can be used to measure biomarkers of iodine and vitamin B12 status in urine and can be employed in large scale trials. Using correlation analyses, the association of urinary iodine and methylmalonic acid from healthy volunteers will be assessed between untreated sample and a sample expressed from a sanitary napkin. Participants will be recruited based on their dietary pattern (omnivorous, vegetarian and vegans) to have a broad spectrum of analyte concentration. Participants weight, height, age, nutritional supplement use and diet will be assessed.

Eligibility criteria: Inclusion Criteria:

Healthy volunteers Written informed consent

Exclusion Criteria:

BMI \< 18,5 and \>24,9 Use of medication (except contraceptives) Smoking

Primary outcomes:
measure: Correlation untreated and expressed urine
timeFrame: 8-9 weeks after completion
Secondary outcomes:
measure: Correlation of urinary biomarkers with food and supplement intake
timeFrame: 8-9 weeks after completion
Other outcomes:
measure: Mean difference of urinary biomarkers between groups
timeFrame: 8-9 weeks after completion
measure: Mean difference of urinary biomarkers between groups
timeFrame: 8-9 weeks after completion
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Wuerttemberg
Study officials:
References:
Clinical trial NCT02492256: Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF
Official title: Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-07-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.


Eligibility criteria: Inclusion Criteria:

1. Male or female patients, age ≥ 18 and ≤ 80 years.
2. Persistent AF (ECG documentation).
3. Indication for AF ablation.
4. LVEF ≥ 50%
5. Able to provide written informed consent
6. Able to comply with the requirements of the study

Exclusion Criteria:

1. Reversible cause of atrial fibrillation
2. Previous AF ablation therapy
3. Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality
4. Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year)
5. Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol
6. Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures
7. Inability to undergo D-SPECT and CT imaging

Primary outcomes:
measure: Number of patients without AF/AFl/AT
timeFrame: 12 months
Secondary outcomes:
measure: Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%).
timeFrame: 12 month
measure: Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT.
timeFrame: 12 month
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology Novosibirsk, Russian Federation
Study officials:
References:
Clinical trial NCT01744756: Subconjunctival Bevacizumab and Recurrent Pterygium
Official title: Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Recurrent Pterygium
Keywords: Subconjunctival Bevacizumab
Recurrent pterygium
Lead sponsor: Instituto de Olhos de Goiania
Sponsor class: OTHER
First posted: 2012-12-07
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Detailed description: 1. Pacients with recurrent pterygium
2. Anti-VEGF therapy -Bevacizumab

Eligibility criteria: Inclusion Criteria:

* Recurrent pterygium

Exclusion Criteria:

* Pregnant or lactating women
* History of myocardial infarction
* History of stroke

Primary outcomes:
measure: Pterygium size after subconjunctival bevacizumab
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Instituto de Olhos de Goiania
state: Goias
Study officials:
affiliation: Instituto de Olhos de Goiania
name: Larissa S Stival, MD
role: STUDY_CHAIR
References:
citation: Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.
Clinical trial NCT03972956: Samples Procurement for Colorectal Cancer, Gastric Cancer, and Non-malignant Disease
Official title: Samples Procurement for Patients With Colorectal Cancer, Gastric Cancer, and Non-malignant Disease Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Gastric Cancer
Inflammatory Bowel Diseases
Gastric Ulcer
Hemorrhoids
Hernia
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are planning to undergo surgery.

Brief summary: The purposes of this study are to collect and store samples including blood, normal and tumor tissue from patients with colorectal cancer or gastric cancer, to collect and store samples including blood and/or normal gastrointestinal tissue (if available) from patients with non-malignant disease (including, but not limited to, inflammatory bowel disease (IBD), gastric ulcer, hemorrhoids or hernia), and to create a database for the collected samples and allow access to relevant clinical information for current and future protocols.


Eligibility criteria: Inclusion Criteria:

* Any patient diagnosed with colorectal cancer, gastric cancer, non-malignant disease that requires undergoing surgery.
* Must be willing and able to provide informed consent.

Exclusion Criteria:

* Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.

Primary outcomes:
measure: Confirmation of diagnosis by pathologist
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Renmin Hospital of Wuhan University
name: Tao Fu, MD
role: PRINCIPAL_INVESTIGATOR
References: