louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01213485: An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Patients With Chronic Kidney Disease on Dialysis (HORTENSIA)
Official title: Observational Cohort Study in Chronic Kidney Disease Patients on Dialysis Initiating Treatment With Mircera During the Correction and Maintenance Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic kidney disease on dialysis

Brief summary: This observational study will evaluate the course of treatment, the efficacy on anemia and the safety of Mircera (methoxy polyethylene glycol-epoetin beta) in patients with chronic kidney disease on dialysis. Eligible patients will be on either haemodialysis or peritoneal dialysis and treatment-naïve for or having had prior therapy with erythropoiesis stimulating agents (ESA). Data will be collected from each patient for 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic kidney disease, on dialysis for \> 3 months
* Treatment-naïve or previous treatment with ESA
* Initiation of treatment with Mircera for renal insufficiency associated anemia by decision of the treating physician

Exclusion Criteria:

* Participation in a clinical trial
* Anemia due to an associated malignant pathology

Primary outcomes:
measure: Haemoglobin levels
timeFrame: Month 6
measure: Mircera therapy (dosage, schedule, mode of application) in the treatment of anemia in clinical practice
timeFrame: Month 6
Secondary outcomes:
measure: Change in haemoglobin/haematocrit
timeFrame: from baseline to Month 12
measure: Biological parameters of anemia: transferrin saturation, serum ferritin, folates
timeFrame: 12 months
measure: Efficacy of dialysis (Kt/V, urea levels)
timeFrame: 12 months
measure: Safety: Incidence of adverse events
timeFrame: 12 months
measure: Compliance (treatment modification or discontinuation)
timeFrame: 12 months
measure: Quality of life: Short Form (SF-36) questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04538885: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
Official title: Mesenchymal Stem Cell-derived Pleiotropic Factor in Treating Poorly Healed Wounds of Postoperative Incision
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: MSCs-PFs in Treating Poorly Healed Wounds of Postoperative Incision
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Gansu Provincial Maternal and Child Health Care Hospital
First posted: 2020-09-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Poor incision healing is a common complication after abdominal surgery, mainly manifested as incision dehiscence, subcutaneous fat liquefaction, malnutrition, and incision infection. Poor healing of the incision will increase the patient's pain and prolong the patient's hospital stay, and the choice of wound treatment is closely related to the wound healing effect. Mesenchymal stem cells mainly rely on paracrine effects to exert their therapeutic effects and obtain better therapeutic effects in wound healing. Here, the pleiotropic factors secreted from mesenchymal stem cells (MSCs-PFs) will be used to treat patients with poor healing after surgery to evaluate its effectiveness and safety.


Eligibility criteria: Inclusion Criteria:

1. Wound size \<10X10cm2, the wound base only involves subcutaneous and muscle tissue；
2. Underwent surgical treatment, all incisions were type I, and the incisions healed poorly and delayed healing after 1 week；
3. There is inflammatory reaction at the incision, but no clear indication of infection, or severe infection of the incision.After debridement and dressing change, the infection is controlled and the fresh granulation period is entered
4. Men or women older than 17 years old and younger than 75 years old;
5. Psychologically stable, able to complete the test process.

Exclusion Criteria:

1. Wound size\>10X10cm2, the wound base is as deep as the chest and abdominal cavity, causing infection or osteomyelitis in the chest and abdominal cavity;
2. Surgical incision with purulent infection, local purulent secretions can be seen;
3. Those with obvious body temperature and white blood cell elevation, local purulent secretions have positive bacterial culture;
4. Patients with diabetes;
5. Glucocorticoid users;
6. Patients with immune dermatosis;
7. Neoplastic wounds, such as wounds after skin cancer resection, or skin wounds caused by tumor invasion;
8. Psycho-psychological disorders and poor compliance.

Primary outcomes:
measure: Wound healing time and healing rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02228785: A Study of the Safety and Tolerance of Three Doses of G17DT in Metastatic Colorectal Cancer
Official title: Study of the Safety and Tolerance of Three Doses of G17DT in Patients With Metastatic Colorectal Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Colorectal Cancer
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-29
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This study was designed to investigate the safety and tolerance of three doses (100µg, 200µg, 500µg) of G17DT for the treatment of patients with colorectal cancer.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or over with histologically verified adenocarcinoma of colon or rectum.
* Recurrent of metastatic disease not amenable to curative surgery and/or radiotherapy.
* Life expectancy greater than 3 months.
* Karnofsky Index Score greater than or equal to 50%.
* Written informed consent obtained.

Exclusion Criteria:

* Neoplastic lesions other than colorectal cancer (except treated basal cell carcinoma of the skin or cancer of the uterine cervix, through Stage I.
* Acute intercurrent illness.
* Patient considered to be a medical risk because of non-malignant systemic disease or grossly abnormal laboratory results.
* Patients who had received any other anticancer therapy within 3 months.
* Factor liable to alter the serum gastrin concentration or affect intra-gastric acidity, for instance concomitant therapy with H2 receptor antagonist drugs, proton pump inhibitors, or previous gastric surgery.
* Patients immunologically compromised including those on corticosteroid therapy.
* Women of child-bearing age.
* Positive immediate hypersensitivity reaction to skin testing with study medication.
* Patients unable to complete the diary book
* Haematogical Status Haemoglobin count less than 10g/dL White Blood Cell count less than 4.0 x 10\^9/L Platelet count less than 100 x 10\^9/L

Primary outcomes:
measure: Injection Site Reaction
timeFrame: Through Week 12
measure: Antibody Levels
timeFrame: Through Week 12
Secondary outcomes:
measure: Intra-gastric pH
timeFrame: Through Week 8
Other outcomes:
Locations:
Study officials:
affiliation: University of Nottingham
name: J D Hardcastle, MChir, FRCP, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05266885: Prevalence of Hypertension in Type-2 Diabetes Mellitus
Official title: Prevalence of Hypertension in Type-2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevalence of Elevated Blood Pressure in Type-2 Diabetics
Keywords: Prevalence; Hypertension; Type-2 diabetes
Lead sponsor: Kabul University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Type -2 diabetics who were presented to our center from November 2019 to January 2020.

Brief summary: Cardiovascular disease is the most prevalent cause of morbidity and mortality in diabetic patients. Hypertension has been confirmed as a major risk factor for cardiovascular disease, which is frequently associated with diabetes mellitus. Therefore, the detection and management of elevated blood pressure (BP) is a critical component of the comprehensive clinical management of diabetics. Since the rates of hypertension in diabetics are lacking in Afghanistan, this study aimed to evaluate the prevalence of elevated blood pressure in type-2 diabetic patients.

Detailed description: Cardiovascular disease is the most prevalent cause of morbidity and mortality in diabetic patients. Hypertension has been confirmed as a major risk factor for cardiovascular disease, which is frequently associated with diabetes mellitus. Therefore, the detection and management of elevated blood pressure (BP) is a critical component of the comprehensive clinical management of diabetics. Since the rates of hypertension in diabetics are lacking in Afghanistan, this study aimed to evaluate the prevalence of elevated blood pressure in type-2 diabetic patients.

This is a descriptive cross-sectional study, which included 322 type -2 diabetic patients (37 male, 63 female) who were presented to our center from November 2019 to January 2020.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed diabetic patients
* Newly diagnosed Diabetics
* known case of diabetes

Exclusion Criteria:

* The patients who were seriously ill
* Pregnant women
* Type-1 diabetic patients,

Primary outcomes:
measure: High incidence of HTN in Diabetics
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: Habib Ahmad Esmat
state: None Selected
Study officials:
affiliation: KMUs
name: Mohammad wali Nasary, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03046485: Use of Self-management Group to Improve Quality of Life in Patients With Low Vision
Official title: A Randomized Controlled Trial to Assess if Attending an Interactive, Self-management Group, 'Living With Vision Loss', in Addition to Having Vision Rehabilitation in Our Clinic, Improves Patients' Quality of Life
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Age Related Macular Degeneration
Keywords: AMD
vision loss
self-management strategies
low-vision rehabilitation
IVI
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 120 Patients with visual acuity \<6/12 will be randomized to receive either usual care or participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We hypothesize that a structured self-management low-vision rehabilitation program provides a greater improvement in participation in daily activities, and improves quality of life in vision-impaired people compared to the provision of the usual low vision rehabilitation services. We also plan to document barriers that prevent patients with low vision (visual acuity \<6/12) from participating in self-management course.


Eligibility criteria: Inclusion Criteria:

* Clients who have attended the MEEI Vision Rehabilitation for the first time within 12 months
* Visual acuity of \<6/12 in the better eye with habitual correction
* Age 55+ years
* Living independently (not in a nursing home)
* English speaking
* No cognitive impairment
* Adequate hearing to respond to normal conversation

Exclusion Criteria:

* vestibular disease

Primary outcomes:
measure: Impact of Vision Impairment Questionnaire (IVI)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Vision Rehabilitation Center
state: Massachusetts
Study officials:
affiliation: MEEI Vision REhabilitation Center Dir.
name: Mary Lou Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04991285: People of Color and Dermatology: A Deeper Look at Patients' Perceptions of Care and the Need for Greater Diversity in Dermatology
Official title: People of Color and Dermatology: A Deeper Look at Patients' Perceptions of Care and the Need for Greater Diversity in Dermatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatology
Keywords: People of color, dermatology training
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People of color who are over the age of 18 years old, English speaking/ English proficient and living in the U.S.

Brief summary: Surveys will be collected to evaluate views from people of color and their dermatology experience. The information collected will look at patients' perceptions of care and the need for greater diversity in dermatology.

Detailed description: This survey looks to gain a much-needed perspective from POC in order to better understand their views on 1. the field of dermatology 2. the diversity in dermatology and its acceptance of skin of color and hair 3. skin of color centers 4. Race concordant dermatology and 5. perceived views on dermatologic training. The sample size will be the number of participants that respond to the survey, with a target sample size of 1000 respondents. Eligible participants need to identify with at least one of the following groups

* Black or African American
* Latinx
* American Indian or Alaska Native
* Native Hawaiian or Pacific Islander
* Asian

Participants will need to be over the age of 18 years old, English-speaking/English proficient and anticipated to be living within the United States. Recruitment and screening will be done through ResearchMatch.

Eligibility criteria: Inclusion Criteria:

Eligible participants need to identify with at least one of the following groups

* Black or African American
* Latinx
* American Indian or Alaska Native
* Native Hawaiian or Pacific Islander
* Asian
* Over the age of 18 years old
* English-speaking/ English proficient
* Anticipated to be living within the United States

Exclusion:

Subjects who do not meet the inclusion criteria

Primary outcomes:
measure: Frequency (percentage) of participants with knowledge of skin of color clinics/training
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Fienberg School of Medicine Department of Dermatology
state: Illinois
Study officials:
References:
Clinical trial NCT02586285: Effect of S-Adenosyl Methionine Treatment on Recurrence After Curative Resection of Hepatocellular Carcinoma
Official title: A Randomized Controlled Study on the Effect of S-Adenosyl Methionine Treatment on Anti-tumor Recurrence After Curative Resection of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Keywords: S-Adenosyl Methionine
Recurrence
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2015-10-26
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: The aim of this study is to explore the effect of S-Adenosyl Methionine on recurrence after curative resection of Hepatocellular Carcinoma.

Detailed description: Hepatocellular carcinoma (HCC) is now a major health problem. Although the recent advances in treatment of HCC have significantly improved the prognosis of patients with HCC, the overall survival rate is still unsatisfactory; the 5-year survival rate is only 50-70% even after curative treatment such as hepatic resection and percutaneous radiofrequency ablation. One of the reasons for the poor prognosis of HCC is its high rate of recurrence.However,anti-relapse treatment remains a pressing work to do.

In recent years, some study reported that S-Adenosyl Methionine had an impact on promoting apoptosis and inhibiting the growth on breast cancer, colon cancer,gastric cancer and liver cancer in vitro and vivo.

In this study, we aim to examine whether S-Adenosyl Methionine have an effect on improving patients' recurrence after curative resection of Hepatocellular Carcinoma.

Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age
* Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
* Within Milan criteria
* Without or mild liver cirrhosis and the liver function is Child A class.
* Without any other treatments such as TACE、PEI、PRFA before the surgery
* No evidence for extrahepatic metastasis

Exclusion Criteria:

* Patients with macro tumor thrombus or extrahepatic metastasis.
* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction.
* Subjects accepting other trial drugs or participating in other clinical trials.
* Patients refuse to join our trial.
* Female with pregnancy or during the lactation period.

Primary outcomes:
measure: Time to tumor recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern hepatobilliary surgery hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Shen Feng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05910385: TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)
Official title: Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.


Eligibility criteria: Inclusion Criteria:

* Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion
* Able to give informed consent to participate in research
* Affiliated to a social security system.

Exclusion Criteria:

* Current pregnancy or breastfeeding
* Indications of another concomitant surgical procedure (other than procedure on the appendix)
* History of upper genital infection
* Proven or suspected rectovaginal endometriosis on clinical examination
* History of rectal surgery
* Virgin patient
* Any concomitant pathology deemed incompatible with the study.
* Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery.
* Protected adult patient, under guardianship or curatorship
* Patients not affiliated to the social security system
* Patients who do not speak French
* Patients under legal protection
* Refusal to participate.

Primary outcomes:
measure: quality of sexual life
timeFrame: 6 months
Secondary outcomes:
measure: characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)
timeFrame: 6 months
measure: postoperative pain
timeFrame: 6 months
measure: consumption of peroperative analgesics.
timeFrame: 6 months
measure: consumption of postoperative analgesics.
timeFrame: 6 months
measure: per and post-operative complications
timeFrame: 6 months
measure: patient satisfaction
timeFrame: 6 months
measure: quality of life after surgery
timeFrame: 6 months
measure: number of days of sick leave
timeFrame: 6 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Issoire
country: France
facility: CH d'Issoire
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Sandra Curinier
role: PRINCIPAL_INVESTIGATOR
References: