louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05025982: Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema
Official title: Combination of Lymphatico-venular Anastomosis and Liposuction to Treat Cancer-related Lymphedema: Rationale for a Regional Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Description of an Effective Surgical Strategy to Treat Cancer-related Lymphedema
Combination of LVA and Liposuction Guarantees Long Lasting Results
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 24
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 a previous history of cancer who developed secondary lymphedema and are currently free from cancer

Brief summary: * cooperation of an International team with many years of experience in surgical management of lymphedema
* description of an effective surgical strategy to treat cancer-related lymphedema, a high incidence pathology
* the combination of LVA and liposuction guarantees long lasting results

Detailed description: Cancer-related lymphedema represents one of the major complications of cancer treatment, especially for breast and gynecologic cancers. Moreover, it has high impact on cancer survivors and healthcare systems. Lymphedema management still remains challenging. The better understanding of lymphedema physiopathology as well as the development of sophisticated surgical and diagnostic techniques have led to effective strategies to address lymphedema patients but, despite the considerable interest in international literature, no consensus exist. The combination of LVA and liposuction may represent an effective strategy in treating patients with cancer-related lymphedema, in order to reach a significant decrease in volume and reduction of lymphangitis rate as well as stable results in time. In addition, it has the aim of being minimally invasive and well tolerated by patients

Eligibility criteria: Inclusion Criteria: patients affected by secondary lymphedema

* free from cancer disease

Exclusion Criteria:

- persistence of the neoplastic pathology

- patients affected by primary lymphedema

Primary outcomes:
measure: change in volume
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Guido Gabriele
city: Siena
country: Italy
facility: Guido Gabriele
Study officials:
References:
Clinical trial NCT03904082: Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block
Official title: Evaluation of the Efficiency of Erector Spina Plane Block and Serratus Anterior Plane Block for Postoperative Thorasic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thoracic Diseases
Keywords: dispne, pain
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 105
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: To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.

Detailed description: Thoracic wall nerve blocks such as Erector spina Plane block and Serratus Anterior Plane block have become popular for preoperative pain control in patients undergoing thoracotomy.

Eligibility criteria: Inclusion Criteria:

ASA I- ASA II Patients

Exclusion Criteria:

* history of allergy to the study medication
* refusal to participate

Primary outcomes:
measure: opioid consumption
timeFrame: 48 hours after surgery
measure: Verbal analog Pain Scores on rest and movement
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Incidences of adverse effects (like nausea and vomitting)
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Ayşe Ülgey
state: Talas
Study officials:
affiliation: TC Erciyes University
name: Ayşe Ülgey, MD
role: STUDY_DIRECTOR
References:
citation: Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
citation: Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
citation: Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.
Clinical trial NCT06764082: Nutritional Intervention for Biliary Atresia
Official title: Nutritional Intervention With High Chain Triglyceride Formulation During Perioperative Period of Kasai Surgery for Biliary Atresia: a Prospective Multicenter Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nutrition Disorder, Infant
Biliary Atresia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infants with biliary atresia (Biliary atresia, BA) have an increased risk of malnutrition due to insufficient dietary intake to maintain normal growth, impaired intestinal absorption, increased metabolic rate, and damage to some liver macronutrient metabolic pathways. The medium-chain triglyceride formula (MCT) in enteral nutrition has advantages: (1) It has a fast metabolism in the liver and possesses the advantage of being an innate energy source; (2) It can share metabolic pathways with some other fatty acids (DHA, EPA), and can promote the synthesis of phospholipids, etc. Therefore, EN containing the MCT formula is regarded as an important approach to alleviate growth retardation in BA children and improve the nutritional status of patients. This study aims to observe the effect of intensified enteral feeding with a high MCT formula during the perioperative period compared to traditional oral feeding on the prognosis of children with biliary atresia. The method adopted is a prospective, two-arm, open-label, multicenter, and interventional real-world study.


Eligibility criteria: Inclusion Criteria:

* 1. Infants under 3 months old; 2. Children clinically diagnosed with biliary atresia and in need of Kasai surgery; 3. The patient themselves, legal representative or guardian have signed the informed consent form and are willing to actively cooperate with treatment and follow-up.

Exclusion Criteria:

* 1. Low birth weight infants or very low birth weight infants; 2. Complicated with life-threatening diseases of various organ systems; 3. Complicated with other severe digestive tract malformations or other diseases that may interfere with the treatment of the patient or the patient's compliance; 4. Patients who have participated in other clinical trials within the last month; 5. Any other conditions that the researcher deems unsuitable for participation in this trial.

Primary outcomes:
measure: age by weight Z score
timeFrame: 6 months
Secondary outcomes:
measure: age by height Z score
timeFrame: 6 months
Other outcomes:
measure: age by BMI Z score
timeFrame: 6 months
measure: Jaundice clearance rate
timeFrame: 6 months
measure: The incidence of post-operative cholangitis
timeFrame: 6 months
measure: length of hospital stay
timeFrame: 2 weeks
Locations:
Study officials:
References:
Clinical trial NCT05135182: Helicobacter Pylori Rescue Treatment in Patients Allergic to Penicillin
Official title: Helicobacter Pylori Rescue Treatment Containing Tetracycline in Patients Allergic to Penicillin:a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Eradication
Allergic
Penicillin
Tetracycline
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 170
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 purpose of this study is to assess and compare the effectiveness of furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection inpatients allergic to penicillin.

Detailed description: Helicobacter pylori(H.pylori), which infects about 50% of the global population,has been recognized as a main risk factor of multiple gastric pathologies,especially non-cardiac gastric cancer. Strongly evidence supports that H.pylori eradication is an effective approach to reduce the incidence of those pathologies.However,Helicobacter pylori eradication is a challenge in patients allergic to penicillin. Therefore, the investigators aim to assess and compare the effectiveness of furazolidone-tetracycline-containing and metronidazole-tetracycline-containing quadruple regimens for the rescue treatment of Helicobacter pylori infection in patients allergic to penicillin.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 with H. pylori infection.
* Patients with previous Helicobacter pylori eradication.
* Patients Allergic to Penicillin.

Exclusion Criteria:

* Patients treated with H2-receptor antagonist, PPI, bismuth and antibiotics in the previous 4 weeks.
* Patients with gastrectomy, acute GI bleeding and advanced gastric cancer.
* Patients with known or suspected allergy to study medications.
* Currently pregnant or lactating.
* Inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.

Primary outcomes:
measure: Eradication rates in 2 groups
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416582: Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
Official title: Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Mucositis Oral
Dehydration
Head and Neck Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.


Eligibility criteria: Inclusion Criteria:

* Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head \& Neck Cancer
* Over 18 years old
* Eligible for concurrent Chemoradiation in the first line setting
* Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
* Able to read \& write English or Spanish

Exclusion Criteria:

* Under 18 years old
* Underlying Anxiety or Depression (must pass screening tools)
* Medically Diagnosed with a Cognitive Impairment
* No prior Chemotherapy or Radiation treatment
* No access to a telephone
* Blind or Deaf or Illiterate
* Requires assistance with Self-Care ADLs

Primary outcomes:
measure: Number of participants that completed calls
timeFrame: 6 weeks
measure: Duration of phone call
timeFrame: 6 weeks
measure: Percentage of patients using Intervention materials
timeFrame: 6 weeks
Secondary outcomes:
measure: Attrition Rate
timeFrame: 6 weeks
measure: Study Completion Rate
timeFrame: 6 weeks
measure: Participant Satisfaction
timeFrame: 6 weeks
measure: Change in severity of mucositis
timeFrame: 6 weeks
measure: Change in overall symptom severity
timeFrame: 10 weeks
measure: Change in quality of life
timeFrame: 10 weeks
measure: Unscheduled Medical Visits
timeFrame: 6 weeks
measure: Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy
timeFrame: 10 weeks
measure: Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Raphael Yechieli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896882: Dietary Sodium Restriction in Hemodialysis Patients
Official title: Effects of Dietary Sodium Restriction in Hemodialysis Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Patients
Keywords: Diet, Sodium-Restricted
Food and Nutrition Education
Renal Dialyisis
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 112
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: Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.

Exclusion Criteria:

* Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.

Primary outcomes:
measure: Sodium intake
timeFrame: Baseline, 30, 90, 180 and 360 days
measure: Quality of life
timeFrame: Baseline, 180 and 360 days.
Secondary outcomes:
measure: Interdialytic weight gain
timeFrame: Baseline, 30, 90, 180 and 360 days.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Gabriela Corrêa Souza, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609982: SSNHL in Head & Neck Cancer Patients
Official title: Randomized Controlled Trial Evaluating the Impact of Noise Exposure in Otolaryngology Floor Among Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A sound dosimeter will be used to measure noise level to which a population of head and neck patients on the otolaryngology ward are exposed to. The device is the EXTECH 407764 type II sound level meter (IEC 651 RS232). The device will be configured to OSHA and ISO standards, and calibration confirmed in a sound booth with a sound level calibrator. The dosimeter captures A-weighted sound levels between 30 and 130 dB. Specifically, participants included in the study will be head and neck cancer patients on the otolaryngology floor at VG site. Measurements will be taken three times a day at random intervals. Each measurement will be taken in a similar manner. The dosimeter will be placed on the head side of the bed at the level of patient's ear one inch away from the ear and kept there for ten seconds to get a representative level. The overall measurements will be averaged (Leq) for statistical analysis. Investigators will randomly select 50% of the patients and give them protective ear plugs to be used while the participants are inpatients, and the other 50% will not provide them with ear plugs (like what is being done now). Investigators will obtain a baseline hearing test prior to admission and 7 days after admission and then a repeat hearing test at 3 weeks after discharge. The goal is to establish if there is a temporary or a permanent threshold shift.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnoses of head and neck disease requiring surgery.
* Must be expected to be admitted to ENT floor.
* Must be able to conduct a hearing test.

Exclusion Criteria:

* a diagnoses of SNHL.
* participants with low mental capacity.

Primary outcomes:
measure: Hearing loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03112382: Effect of SLC30A8 rs13266634 Genetic Polymorphism on Zinc Supplementation and Glycemic Control in Egyptian Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type II
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Study whether SLC30A8 rs13266634 polymorphism is associated with type 2 diabetes mellitus (T2DM) susceptibility in Egyptian patients and study effect of Zn supplementation on glycemic control in patients with type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* Established diagnosis of type 2 diabetes mellitus.
* Age between 20 and 64 years.
* BMI \< 40 kg/m2.
* On fixed oral hypoglycemic dosage for at least 3 months.
* Normal serum creatinine (0.5 to 1.3 mg/dL) with no clinical evidence suggestive kidney disease.
* Normal liver function tests (ALT 7 to 55 U/L, and albumin ˃ 3.5 g/dL).

Exclusion Criteria:

* Those diagnosed of osteomalacia, chronic alcoholics. Patients with type 1 Diabetes Mellitus.
* Those who were taking multivitamin containing zinc or magnesium or any sort of mineral supplements in the previous three months or hormone replacement therapy (estrogen, progesterone) or chelating therapy such as penicillamine, or anticonvulsant (phenytoin, valproate).
* Those with a history of recent surgery or with concurrent acute illness including infectious disease, trauma, inflammatory bowel disease, malignancy, and active immunological diseases, using corticosteroids.
* Pregnant or intend to be pregnant for t least 3 months or lactating women.
* Those who were receiving insulin preparations as a part of diabetes management.

Primary outcomes:
measure: SLC30A8 rs13266634 polymorphism
timeFrame: one year
measure: serum zinc
timeFrame: at base line
Secondary outcomes:
measure: change from baseline in fasting and 2hr post prandial blood glucose at three months
timeFrame: at base line and after three months
measure: change from baseline in HbA1c at three months
timeFrame: base line and three months
measure: change from baseline in lipid profile at three months
timeFrame: base line and three months
measure: change from baseline in fasting serum insulin at three months
timeFrame: baseline and three months
measure: change from baseline in ALT level at three months
timeFrame: baseline and three months
measure: serum Mg
timeFrame: baseline
measure: creatinine level
timeFrame: baseline
measure: serum Iron
timeFrame: baseline
measure: change from baseline in total serum Calcium at three months
timeFrame: baseline and three months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: theoutpatient clinics, department of internal medicine, Cairo University teaching hospitals,
Study officials:
References:
Clinical trial NCT00002482: Monoclonal Antibody Plus Cyclophosphamide in Treating Patients With Metastatic Cancer
Official title: A PHASE I-II TRIAL OF MUROMONAB (OKT-3) WITH LOW-DOSE CYCLOPHOSPHAMIDE
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Keywords: unspecified adult solid tumor, protocol specific
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2004-06-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody and cyclophosphamide in treating patients with metastatic cancer.

Detailed description: OBJECTIVES: I. Evaluate the clinical feasibility and toxicity of monoclonal antibody OKT3 given with low-dose cyclophosphamide in patients with advanced malignancies. II. Perform serial immune monitoring on patients treated with this regimen. III. Identify any clinical responses produced by this regimen.

OUTLINE: Biological Response Modifier Therapy with Suppressor Cell Inhibition. Anti-CD3 Murine Monoclonal Antibody OKT3, MOAB OKT3; with Cyclophosphamide, CTX, NSC-26271.

PROJECTED ACCRUAL: At least 9 evaluable patients per diagnostic category will be required initially; if any response is seen during the dose-finding portion of the study, a total of 24 patients with that diagnosis will be entered.

Eligibility criteria: DISEASE CHARACTERISTICS: Metastatic cancer considered incurable by standard therapy and for which no higher priority protocol is available Locally progressive primary brain tumors (e.g., astrocytoma, glioma) are also eligible Brain metastases allowed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-4 (poor performance status brain tumor patients specifically eligible) Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Pulmonary: No history of adult asthma No emphysema No pulmonary insufficiency No pulmonary edema Other: No AIDS or positive HIV serology No pregnant women

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: St. Vincent Medical Center - Los Angeles
state: California
Study officials:
name: Charles L. Wiseman, MD, FACP
role: STUDY_CHAIR
References: