louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06193941: Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits
Official title: Research on the Accurate Diagnosis of Urinary Tract Tumors and the Development of Kits
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Urothelial Carcinoma
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bladder cancer treated in Zhongnan Hospital of Wuhan University

Brief summary: Bladder cancer is the second most prevalent urological malignancy worldwide, with a high incidence and poor patient prognosis. Achieving early diagnosis and intervention for bladder cancer is one of the most important ways to improve clinical management and patient prognosis. Tumor exosomes can be released into biological fluids at an early stage of a tumor, and many studies have shown that exosomal RNA can be used as a reliable biomarker to diagnose tumors in a non-invasive way. Based on the clinical needs for early diagnosis of bladder cancer, we aim to screen several early diagnostic markers with potential predictive value, establish an early diagnostic model for bladder cancer, and validate the validity and reliability of this diagnostic model through a large-scale clinical cohort to complement the diagnosis of early-stage cancers and to improve the rate of early diagnosis of cancer.

Detailed description: In response to the clinical demand for accurate early diagnosis of bladder cancer, this project aims to gradually conduct in-depth research on precise early diagnosis of bladder cancer. This includes establishing key techniques for efficient and convenient enrichment of exosomes, identifying potential exosome biomarkers for bladder cancer based on bladder cancer transcriptome sequencing data, and conducting large-scale clinical cohort studies.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years with defined gender;
2. Preoperative patients are preliminarily evaluated as bladder tumors by cystoscopy, FISH, cytology, or imaging.

Exclusion Criteria:

1. Aged \<18 years;
2. Post-operative or after anti-tumor treatment such as chemotherapy or immunotherapy
3. History of other malignant tumors
4. Specimens with hemolytic conditions;
5. Patients with incomplete, undocumented, and uncooperative data.

Primary outcomes:
measure: RT-qPCR
timeFrame: Urine exosomes were enriched for RT-qPCR within 4 hours after the samples were collected.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Fubing Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01387841: Effect of Yoga in Reducing Chemotherapy Induced Nausea and Vomiting
Official title: Comparison of Yoga Versus Relaxation on Chemotherapy Induced Nausea and Vomiting (CINV) Outcomes Following Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Malignant Female Reproductive System Neoplasm
Lymphomas
Chemotherapy-induced Nausea and Vomiting
Keywords: yoga
chemotherapy
nausea
vomiting
Lead sponsor: Bharath Charitable Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: Bangalore Institute of Oncology
name: CENTRAL COUNCIL FOR RESEARCH IN YOGA AND NATUROPATHY
First posted: 2011-07-06
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: * This randomized controlled three arm study compares the effects of a yoga intervention with jacobsons progressive muscle relaxation training and only standard of care in chemotherapy naive cancer patients.
* This study will also assess the neurophysiological correlates of nausea and vomiting and assess if effects of intervention on nausea and vomiting outcomes are mediated by changes in gastric motility (electrogastrogram) or stress arousal (cardiac autonomic function and sympathetic skin response) or self reported anxiety.


Eligibility criteria: Inclusion Criteria:

* Patients with gynecologic malignancies (breast, ovary) and Lymphomas.
* Age between 30-70 years.
* Chemotherapy naïve.
* High school education.

Exclusion Criteria:

* Those with brain metastases
* Concurring medical condition likely to influence survival
* Uncontrolled diabetes and hypertension
* GI metastases, peritoneal fluid, uraemia
* Neurological disorders such as Parkinson's disease, myotonic dystrophy etc.
* GI obstruction and past H/o abdominal surgeries.
* Cognitive impairments.
* Regular participation in a behavioral intervention/yoga in the last six months

Primary outcomes:
measure: Effect of yoga on chemotherapy induced nausea and vomiting
timeFrame: 4 months (prior to every cycle of chemotherapy,for 4 cycles)
Secondary outcomes:
measure: Quality of life after chemotherapy
timeFrame: 4 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Health Care Global
state: Karnataka
Study officials:
affiliation: HCG
name: RAGHAVENDRA RAO, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00223041: Cranoc Lipid Study in Renal Transplantation
Official title: Cardiovascular Events in Renal Transplant Recipients With Low LDL-cholesterol Receiving Tacrolimus in Combination With the Statin Fluvastatin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Renal Transplantation
Keywords: renal transplantation
cardiovasculary disease
statin
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 200
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: PREVENTION

Brief summary: Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (\<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Detailed description: Cardiovascular disease after renal transplantation is an important problem. Patients after renal transplantation with low LDL-Levels (\<130mg/dl) receive Fluvastatin 80mg/day (or no medication, to look for the cardiovascular outcome with and without statins.

Eligibility criteria: Inclusion Criteria:

* patients (18 - 65, inclusive)
* cadaver and living kidney transplantation (1. Ntx, 2. Ntx)
* LDL-cholesterol ≤ 130mg/dl (-3 Mo until start of Tx)
* Patients with a history of Myocard infarct: LDL-Cholesterol ≤ 110mg/dl
* Immunsuppression: Tacrolimus in combination with steroids or Mycophenolat Mofetil
* patients indulgence

Exclusion Criteria:

* statin before the study

  * LDL-Cholesterol \>130mg/dl before transplantation
  * Instabil Angina, Myocard infarct \<6 months before transplantation
  * symptomatic Hypothyreosis
  * child bearing, lactating
  * elavated liver encymes (\> 2x elavated: AST, ALT, bilirubine, PCK)
  * Fibrates are not allowed
  * multiorgantransplantation

Primary outcomes:
measure: cardivasculary events (cardiovaskulary, cerebrovaskulary, peripher vaskulary)
timeFrame: during the study
Secondary outcomes:
measure: patients and kidney survival
timeFrame: during the study
measure: amount and typ of rejection (Banff-classifikation)
timeFrame: during the study
measure: change in lipids
timeFrame: during the study
measure: adverse events of the statin fluvastatin
timeFrame: during the study
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University of Schleswig-Holstein, Campus Kiel, Department of Nephrology
Study officials:
affiliation: University of Scghleswig-Holstein, Campus Kiel, Department of Nephrology
name: Lutz Renders, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550641: Pool-based Exercise in Fibromyalgia Management
Official title: Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fibromyalgia
Keywords: fibromyalgia
pool-based exercise
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).


Eligibility criteria: Inclusion Criteria:

* diagnosis of fibromyalgia according to the ACR criteria
* 18 years or older
* written informed consent to participate

Exclusion Criteria:

* unable to tolerate warm chlorinated water
* associated medical condition contraindicating exercise in warm water

Primary outcomes:
measure: Improvement in fibromyalgia symptomatology
timeFrame: 18 weeks
Secondary outcomes:
measure: Improvement in sleep, depressive and anxiety symptomatology and quality of life
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario "Virgen de las Nieves"
Study officials:
affiliation: Professor of Clinical Pharmacology
name: Elena P. Calandre
role: STUDY_DIRECTOR
affiliation: physiotherapist
name: Mª Luz Rodriguez-Claro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calandre EP, Rodriguez-Claro ML, Rico-Villademoros F, Vilchez JS, Hidalgo J, Delgado-Rodriguez A. Effects of pool-based exercise in fibromyalgia symptomatology and sleep quality: a prospective randomised comparison between stretching and Ai Chi. Clin Exp Rheumatol. 2009 Sep-Oct;27(5 Suppl 56):S21-8.
Clinical trial NCT00073541: A Study of the Safety and Effects of EMD 72000 in Subjects With Recurrent Ovarian Cancer
Official title: An Open-Label Phase II Study in Subjects With Recurrent EGFR-Positive Ovarian Cancer to Investigate the Safety and Efficacy of EMD 72000 Administered as a Single Agent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: EGFR; HER-1; monoclonal antibody; targeted therapy
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2003-11-26
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: EMD 72000 is an experimental, biological drug. Studies in animals indicate that EMD 72000 blocks a factor found on the surface of many cancer cells. The factor is called epidermal growth factor receptor or EGFR. One type of cancer which frequently contains EGFR is ovarian cancer. This study will test the safety and effects of EMD 72000 in subjects with EGFR-positive recurrent ovarian cancer following standard treatment that has failed.


Eligibility criteria: Inclusion Criteria:

* Recurrent ovarian cancer (including primary peritoneal cancer) following treatment (e.g., doxorubicin HCL liposome, topotecan, etc.) for primary or secondary platinum-refractory disease
* Immunohistochemical evidence of tumor EGFR (HER-1) expression
* At least one measurable lesion according to the WHO criteria
* Life expectancy ≥ 12 weeks
* ECOG performance status 0-1

Exclusion Criteria:

* History of prior MAb therapy
* History of prior treatment with an EGFR (HER-1) directed therapy
* Known brain metastases
* Presence of a ≥ Grade 2 pre-existing skin disorder (alopecia is permitted)
* Known intercurrent infections or immunosuppression
* Actively infected with, or chronic carriers of HBV
* Evidence of HCV disease
* Previous diagnosis of autoimmune disease
* Known hypersensitivity to the administered drugs or any of their components
* Receipt of chemotherapy, radiation therapy, or another investigational drug within 30 days of enrollment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Nashville
country: United States
state: Tennessee
Study officials:
References:
citation: Seiden MV, Burris HA, Matulonis U, Hall JB, Armstrong DK, Speyer J, Weber JD, Muggia F. A phase II trial of EMD72000 (matuzumab), a humanized anti-EGFR monoclonal antibody, in patients with platinum-resistant ovarian and primary peritoneal malignancies. Gynecol Oncol. 2007 Mar;104(3):727-31. doi: 10.1016/j.ygyno.2006.10.019. Epub 2006 Nov 28.
Clinical trial NCT00468741: Component and Couple Analysis of Cancer Communications
Official title: Component and Couple Analysis of Cancer Communications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Internet
Computer
Support
Information
Education
Control Group: Usual care and Internet access
CHESS Information Services only
CHESS Social Support & Information Services
CHESS Information, Social Support & Skills Services
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-03
Enrollment: 338
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Component and Couple Analysis of Cancer Communication

CHESS, the Comprehensive Health Enhancement Support System is an innovative technology that provides information, social support and skills training to women with breast cancer. Previous CHESS clinical trials found improved patient outcomes but little is known about what services in CHESS produce those results. This study will examine whether breast cancer patient outcomes change when conceptually distinct CHESS services (information, social support, and skills training) are systematically added to a patients treatment resources.

Primary Aims:

* Determine the relative efficacies of different types of cancer communication treatments when they are presented alone or in combination
* Determine routes or processes via which these elements work
* Determine for whom the different treatment types work best.


Eligibility criteria: Inclusion Criteria:

Eligibility for this protocol is as follows:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age,
* All subjects must be able to read and write English at the 6th-grade level
* Not homeless

Primary outcomes:
measure: Patient Quality of Life
timeFrame: monthly
Secondary outcomes:
measure: Emotional Well-being
timeFrame: monthly
measure: Self Efficacy
timeFrame: monthly
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Houston
country: United States
facility: M. D. Anderson
state: Texas
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy Baker, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04752241: Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
Official title: Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Function Disturbances
Keywords: Sexual function
Colonic diverticular disease
Inferior mesenteric artery-preserving
Neosigmoid Denervation
Postoperative sexual dysfunction
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate whether IMA sparing may represent an advantage in terms of reduced incidence and severity of sexual dysfunctions after colorectal resections for diverticular disease (DD).

Detailed description: Enrolled patients were randomly divided into 2 treatment groups. In the first group (IMAP) the IMA was preserved sectioning the sigmoid arteries near colonic wall while, in the second group (IMAS) the IMA was sectioned immediately below the origin of the left colic artery. Incidence and severity of sexual dysfunction and QoL were assessed by four validated questionnaire administered 6,12 months and 5 and 8 years after surgery.

Eligibility criteria: Inclusion Criteria:

* diverticular disease
* Diverticulitis
* BMI under 35 Kg/mq
* ASA score from I to III
* Standardized sigmoid, left colon or rectal resection

Exclusion Criteria:

* complicated diverticulitis (Hinchey III-IV)
* previous abdominal surgery or prostatic and/or gynecological resections
* adverse local condition or the need of multiorgan resection or stoma creation

Primary outcomes:
measure: Sexual disfunction 1
timeFrame: 12 months after surgery
measure: Sexual disfunction 2
timeFrame: 6 years after surgery
Secondary outcomes:
measure: Sexual Function Male 1
timeFrame: 12 month after surgery
measure: Sexual Function Male 2
timeFrame: 6 years after surgery
measure: Sexual Function Female 1
timeFrame: 12 months after surgery
measure: Sexual Function Female 2
timeFrame: 6 years after surgery
measure: Quality of Life 1
timeFrame: 12 months after surgery
measure: Quality of Life 2
timeFrame: 6 years after surgery
measure: Quality of life SF-36 1
timeFrame: 12 months after surgery
measure: Quality of life SF-36 2
timeFrame: 6 years after surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
Study officials:
References:
Clinical trial NCT00334841: Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Official title: Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes Mellitus
Preeclampsia
Placental Hypoxia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-06-08
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be a satiety factor. In addition, it has been shown to increase during pregnancy in maternal blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to fall down to basal levels after delivery.

Little is known about leptin levels in pregnant women with preexisting or gestational diabetes and their relationship with fetal and postnatal growth and perinatal complications.

Therefore, the proposed study aims to understand and characterize the role of leptin in gestational diabetes mellitus as well as the relationship between leptin, cytokines and the pathophysiological complications during diabetic pregnancy. Specifically, we will evaluate 60 pregnant women both in Germany and in Israel and evaluate serum levels and mRNA of leptin, cytokines (inflammatory as well as Th1 and Th2) and correlate them to maternal changes of body weight and birth weight in women of various degrees of glucose tolerance and with various degrees of metabolic control during pregnancy; relationship between serum and umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental expression of leptin, leptin receptor, selected cytokines, GLUT1 and 4 and relationship to leptin in serum and umbilical cord plasma; comparison between all above parameters of German and Israeli pregnant women.

The results of this new and systematic study will shed light on the role of leptin and cytokines in the development of glucose disturbances during pregnancy and the perinatal outcome of women with gestational or preexisting diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

random glucose challenge test (GCT): 50 g of glucose are orally given at any time of the day. The results are considered as positive if the capillary blood glucose concentrations 1 hour after the load are \>130 mg/dl. Those with normal results serve as control group

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Uriel Elchalal, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lappas M, Yee K, Permezel M, Rice GE. Release and regulation of leptin, resistin and adiponectin from human placenta, fetal membranes, and maternal adipose tissue and skeletal muscle from normal and gestational diabetes mellitus-complicated pregnancies. J Endocrinol. 2005 Sep;186(3):457-65. doi: 10.1677/joe.1.06227.