louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00944138: 8-week Pilot Study of Relaxation for Weight Loss in Adults With Chronic Kidney Disease
Official title: Randomized 8-week Pilot Study of Relaxation Methods for Weight Loss in Adults With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Keywords: Obesity
meditation
chronic kidney disease
Lead sponsor: Edward Hines Jr. VA Hospital
Sponsor class: FED
First posted: 2009-07-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity plays a causal role for kidney disease incidence and progression. Moderate weight loss reduces the high metabolic demands on the kidney and decreases proteinuria in both diabetic and non-diabetic nephropathies. However, maintaining behavioral changes for weight loss is very challenging, and common chronic kidney disease (CKD) co-morbidities such as decreased exercise capacity only compound this difficulty. Moreover, no weight loss medications have been adequately tested in adults with CKD and most are contraindicated in this population. Mindful meditation or "mindfulness" in addition to other relaxation techniques may help adults lose weight by interrupting learned behavior, curbing compulsive eating, and reducing stress and appetite. Although mindful meditation and other relaxation techniques have gained the attention of the mainstream media for obesity treatment, scientific data on its efficacy remain limited. Due to the short duration of this study, substantial weight loss in any participant is not expected. Instead, the primary purpose of this study is to examine the feasibility of a randomized controlled trial of mindful meditation relaxation techniques combined with standard care compared to standard care alone for the treatment of obesity among Veterans with CKD.


Eligibility criteria: Inclusion Criteria:

* receive medical care at the Hines VA CKD clinics.
* Presence of chronic kidney disease defined as an estimated glomerular filtration rate \< 60 ml/min/1.73 m2 BSA or a spot urine albumin/creatinine ratio ≥ 30 mg/g
* BMI ≥ 35 kg/m2 or a waist circumference ≥ 102 (40 inches) and ≥ 88 cm (35 inches) in men and women, respectively.

Exclusion Criteria:

* Inability to give informed consent
* inability to come to VA for two group sessions
* inability to listen to an MP3 player using headphones

Primary outcomes:
measure: weight, waist circumference, measures of stress and mood and overall satisfaction
timeFrame: 8 nweeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT04083638: The Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants
Official title: Investigation of the Relationship Between Erythrocyte Transfusion and Nutrition and Necrotizing Enterocolitis in Preterm Infants: a Randomized Controlled Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Necrotizing Enterocolitis of Newborn
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
First posted: 2019-09-10
Enrollment: 81
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants

Brief summary: In this study; The aim of this study was to investigate the changes in fasting and dietary and mesenteric blood flow in the acute period during and after transfusion and to evaluate the necrotizing enterocolitis.


Eligibility criteria: Inclusion Criteria:

* \<32 gestational week and/or \<1500 g birth weight

Exclusion Criteria:

* Major congenital anomalies, hemodynamic instability

Primary outcomes:
measure: necrotizing enterocolitis
timeFrame: 0-48 hours after tx
measure: Mortality
timeFrame: 0-24 hour after tx
Secondary outcomes:
Other outcomes:
Locations:
city: İzmirli
country: Turkey
facility: Behçet Uz Children's Hospital
state: Izmir
Study officials:
affiliation: Behcet Uz Children's Hospital
name: Rüya Çolak, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06865638: Efficacy and Safety of Colorectal Anastomotic Leak Testing
Official title: A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Leakage Testing
Colorectal Surgery
Complications
Anastomotic Leakage
Lead sponsor: Nanchong Central Hospital
Sponsor class: OTHER_GOV
First posted: 2025-03-10
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.
2. Aged between 18 and 85 years.
3. American Society of Anesthesiologists (ASA) physical status classification is I - III.
4. The patient or his/her legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.

Exclusion Criteria:

1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.
2. Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.
3. Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate \< 30 ml/min).
4. Patients with coagulation disorders (such as platelet count \< 50×10⁹/L, international normalized ratio (INR) \> 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.
5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.
6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.
7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.

Primary outcomes:
measure: Number of Participants with Anastomotic Leak within 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Number of Participants with Postoperative Complications within 30 days
timeFrame: 30 days
Other outcomes:
Locations:
city: Nanchong
country: China
facility: Nanchong Central Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT00004938: Phase II Study of Fluconazole for Lymphocutaneous and Visceral Sporotrichosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sporotrichosis
Keywords: fungal infection
rare disease
sporotrichosis
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: University of Alabama at Birmingham
First posted: 2000-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVE:

I. Evaluate the efficacy of fluconazole in patients with lymphocutaneous or visceral sporotrichosis.

Detailed description: PROTOCOL OUTLINE:

Patients are treated with daily oral fluconazole for up to 24 months. Follow-up continues for at least 1 year.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Presumptive evidence of sporotrichosis Culture-proven sporotrichosis determined on study Relapsing disease following antifungal therapy eligible if culture positive for Sporothrix schenckii prior to entry No life-threatening disease No central nervous system sporotrichosis --Prior/Concurrent Therapy-- No concurrent drugs known to react with fluconazole No more than 3 days of systemic antifungals for current sporotrichosis episode --Patient Characteristics-- Hepatic: Liver function tests no greater than 5 times normal Other: No HIV infection No pregnant or nursing women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: William Dismukes
role: STUDY_CHAIR
References:
citation: Kauffman CA, Pappas PG, McKinsey DS, Greenfield RA, Perfect JR, Cloud GA, Thomas CJ, Dismukes WE. Treatment of lymphocutaneous and visceral sporotrichosis with fluconazole. Clin Infect Dis. 1996 Jan;22(1):46-50. doi: 10.1093/clinids/22.1.46.
Clinical trial NCT06941038: Intraoperative vs. Postoperative Intravesical Epirubicin Instillation for Prevention of Bladder Recurrence in High-Risk Upper Urinary Tract Urothelial Carcinoma
Official title: Effect of Intravesical Chemotherapy on Disease Recurrence in Patients Undergoing Nephroureterectomy for Upper Urinary Tract Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer Recurrence
Intravesical Instillation
Upper Urinary Tract Carcinoma
Keywords: bladder cancer
bladder cancer recurrence
intravesical instillation
upper urinary tract carcinoma
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-23
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care clinic

Brief summary: Upper urinary tract urothelial carcinoma (UTUC) accounts for 5%-10% of urothelial malignancies, with up to 50% of patients developing bladder recurrence post-RNU. High-risk UTUC (≥pT2, high-grade, or N+ disease) necessitates aggressive management. Intravesical chemotherapy mitigates recurrence risk, yet optimal timing-intraoperative vs. postoperative-remains unclear. This study evaluates intraoperative epirubicin instillation during RNU compared to postoperative administration and no instillation.


Eligibility criteria: Inclusion Criteria:

* primary high-risk UTUC.

Exclusion Criteria:

* prior bladder cancer,
* low-risk UTUC (managed conservatively),
* metastatic disease,
* incomplete follow-up

Primary outcomes:
measure: To evaluate the relationship between intravesical chemotherapy administered intraoperatively or postoperatively and bladder recurrence.
timeFrame: 365 days from the first instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent, Ankara, Ankara 06800
Study officials:
References:
Clinical trial NCT06352138: Comparative Study of Two Recombinant Human Erythropoietin Products in Chronic Kidney Disease Patients
Official title: Phase III, Multicentre, Double-blind, Randomised, Parallel, Equivalence Clinical Trial to Assess Efficacy, Safety of Megalabs® Recombinant i/v Human Erythropoietin Compared to Epogen® in Anaemia in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Megalabs
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre, double-blind, randomised, parallel, equivalence trial
Primary purpose: TREATMENT

Brief summary: Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for intravenous use, compared to Epogen®, in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis

Detailed description: Patients with chronic kidney disease undergoing hemodialysis will be administered human recombinant alfa epoetin to revert anemia. Hemoglobin, hematocrit and reticulocyte counts will be assessed. Immunogenicity will be evaluated through bi-weekly Anti Drug Antibody determination. Test drug and comparator drug will be compared to evaluate biosimilarity.

Eligibility criteria: Inclusion Criteria:

* Stage V Chronic kidney disease undergoing hemodialysis

Exclusion Criteria:

* Lack of consent to participate in the trial, other severe chronic disease, history of pure red cell aplasia, existence of anti erythropoietin antibodies

Primary outcomes:
measure: Mean Absolute Change in Hemoglobin Levels
timeFrame: 18 months
measure: Change in Mean Hb Level
timeFrame: 18 months
Secondary outcomes:
measure: immunogenicity
timeFrame: 18 months
Other outcomes:
Locations:
city: Colonia Nicolich
country: Uruguay
facility: Megalabs
state: Canelones
Study officials:
affiliation: Azidus Principal Investigator
name: Satish Kumar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06808438: Incremental and Decremental PEEP Titration by Diverse Strategies in Subjects with ARDS: a Prospective Physiological Study
Official title: Research on Precision Individualized Mechanical Ventilation Strategies for ARDS Guided by Electrical Impedance Tomography Monitoring and Evaluation of the Differences in Ventilation and Perfusion Distribution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ntubated and mechanical ventilated patients over 18 years with moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg) admitted to the ICU within 48 hours were enrolled from October 2022 to July 2024.

Brief summary: The investigators conducted a prospective physiological observation study on ARDS population, described their physiological and EIT indexes with various PEEP titration methods, and also compared and analyzed those indexes to determine whether there were differences among various PEEP titration methods.The objective of this study was to explore and uncover the physiological differences in response to optimal PEEP in different ways，and analyzed the correlation of the optimal PEEP in these different ways.


Eligibility criteria: Inclusion Criteria:

* Intubated and mechanical ventilated patients in ICU within 48 hours
* Be over 18 years old
* With moderate-severe ARDS (PaO2 /FIO2 ,200 mm Hg)

Exclusion Criteria:

* Severe chronic obstructive pulmonary diseases
* Pulmonary bulla(\>1CM) or pneumothorax or pneumomediastinum or subcutaneous emphysema
* Pregnancy
* BMI≥35kg/m2
* Suspected pulmonary vascular hemorrhage
* Disturbance of consciousness or intracranial hypertension
* Severe cardiac dysfunction (New York Heart Association Class III or IV, acute -Coronary syndrome or persistent ventricular tachyarrhythmia), cardiogenic shock or after major cardiac surgery
* Hemodynamic instability (i.e., mean arterial pressure \[MAP\]\<60 mm Hg despite vasopressor use
* The medical team considering short periods of high pressure to be unsafe
* Contraindications for placement of esophageal pressure catheters (e.g., esophageal varix or fracture of skull base)
* Contraindications for EIT monitoring (including pacemaker, or cutaneous diseases which limiting electrode placement)
* Agonal stage or end-stages of diseases

Primary outcomes:
measure: the value of set PEEP
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan University, Chengdu
state: Sichuan
Study officials:
References:
Clinical trial NCT01436838: China Betaferon Adherence, Coping and Nurse Support Study
Official title: Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis, Chronic Progressive
Keywords: Relapsing-Remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MS center located in general hospital

Brief summary: Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.


Eligibility criteria: Inclusion Criteria:

* Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients
* Having Betaferon treatment, including patients who are

  * First time using; or
  * Re-staring; or
  * Switching from other diseases modifying drugs (DMDs)

Exclusion Criteria:

* Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).

Primary outcomes:
measure: Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment
timeFrame: at 6, 12, 18 and 24 months
Secondary outcomes:
measure: Ways of Coping Questionnaire (WCQ)
timeFrame: at 6, 12, 18 and 24 months
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: at 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Many locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05410938: Intraperitoneal Chemotherapy Versus Triweekly Chemotherapy
Official title: Triweekly Chemotherapy With Bevacizumab Versus Intraperitoneal Chemotherapy as Frontline Therapy in Advanced Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraperitoneal Chemotherapy, Bevacizumab, Ovarian Cancer
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 59
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer

Brief summary: The combination of paclitaxel and carboplatin is the standard first-line chemotherapy for ovarian cancer as recommended by the NCCN Guidelines for Epithelial Ovarian Cancer, and is conventionally given via intravenous route every three weeks. The addition of target therapy (bevacizumab) has shown to improve progression free survival but not overall survival. Several trials have also demonstrated a clinically significant survival advantage associated with intraperitoneal chemotherapy compared to intravenous chemotherapy, and the best outcomes are consistently seen for patients who have no residual disease. This study aims to compare triweekly chemotherapy with bevacizumab versus intraperitoneal chemotherapy in patients with advanced stage ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* women aged 20 and above with FIGO stage II-IV advanced ovarian, fallopian tube or primary peritoneal cancer who received debulking surgery, followed by either triweekly intravenous chemotherapy with bevacizumab or intraperitoneal chemotherapy; women who received neoadjuvant chemotherapy followed by interval debulking surgery were also eligible for participation. Intraperitoneal chemotherapy was defined as having one or more cycles of an intraperitoneal regimen administered.

Exclusion Criteria:

* women who quit half-way or received chemotherapy at other site

Primary outcomes:
measure: Progression free survival
timeFrame: the time interval from the date of surgery or neoadjuvant chemotherapy to clinically defined recurrence, disease progression, or the last follow-up
Secondary outcomes:
measure: Overall survival
timeFrame: the time interval from the date of surgery or neoadjuvant chemotherapy to the date of death from any cause or the last follow-up
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT03731338: Nurse-Led Rapid Access Chest Pain Clinic
Official title: An Exploratory Study of a Nurse-Led Rapid Access Chest Pain Clinic, From the Patients' Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Lead sponsor: The Royal Wolverhampton Hospitals NHS Trust
Sponsor class: OTHER_GOV
First posted: 2018-11-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population targeted will be patients referred to the rapid access chest pain clinic undertaken once a week by the researcher or one colleague on alternate weeks.

Brief summary: This study aims to ascertain the lived experiences of 6 patients attending a nurse-led chest pain clinic via an interview, and to understand the demographics of referred patients.

Detailed description: A qualitative analysis of a nurse-led chest pain clinic will be undertaken to improve understanding of patient experience. Patients who have used this service will be invited to take part in an interview. Patients will be split in to two groups: those reassured and discharged after first attendance, and those who went on to have further diagnostic testing. The aim is to interview three patients from each group to compare experiences and perceptions of a service which previously would have been undertaken by physicians, but is now completely nurse-led.

Eligibility criteria: Inclusion Criteria:

* Patients who have attended the chest pain clinic in the last four month months
* Eighteen years-of-age and older
* Able to give valid consent
* English speaking

Exclusion Criteria:

* Non-English speaking patients
* Patients under 18 years of age
* Patients with any cognitive impairment.
* Any vulnerable patients (defined by the mental health act 2005 as anyone lacking capacity to make decisions, ie, someone with severe impairment in the functioning of the brain).
* Offenders in the care of prison services (for logistical reasons)

Primary outcomes:
measure: Explore the lived experiences through interview
timeFrame: 1 hour
Secondary outcomes:
measure: Outcome of the consultation Effects through interview
timeFrame: 1 hour
Other outcomes:
Locations:
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
Study officials:
affiliation: The Royal Wolverhampton NHS Trust
name: Justin Lewis
role: PRINCIPAL_INVESTIGATOR
References: