louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05265949: The Effects of Weight Loss on Tinnitus Symptoms
Official title: The Effects of Dietary and Physical Activity Interventions on Tinnitus Symptoms: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Tinnitus
Obesity
Keywords: tinnitus
diet
physical activity
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Subjective tinnitus is the perception of irregular sound at different frequencies. Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. This study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms. Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical 8 activity (P.A.), diet, P.A., and control groups. Dietary and anthropometric records, Tinnitus Handicap 9Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were compared at the baseline and at the end of the study.

Detailed description: Although the underlying cause of tinnitus is unclear, increased body weight is known to increase tinnitus symptoms. The present study aimed to determine the effects of dietary and physical activity interventions on tinnitus symptoms.

Sixty-three obese subjects with tinnitus aged 20 to 65 years were divided into diet + physical activity (P.A.) (n = 15), diet (n = 16), P.A. (n = 15), and control (n = 17) groups. Dietary records, anthropometric measurements, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Short-Form Health Survey (SF-36), and Visual Analogue Scale (VAS) of all individuals were recorded and compared at the baseline and at study completion.

Eligibility criteria: Inclusion Criteria:

* obese

Exclusion Criteria:

* diagnosed with tinnitus

Primary outcomes:
measure: Weight Loss
timeFrame: At the end of the 3 months
measure: Tinnitus Severity
timeFrame: At the end of the 3 months
measure: Tinnitus Frequency
timeFrame: At the end of the 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) Score
timeFrame: At the end of the 3 months
measure: Quality of Life Score
timeFrame: At the end of the 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ümüş Özbey
Study officials:
References:
Clinical trial NCT05870449: The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications
Official title: The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Thrombus
Phlebitis
Infections
Lead sponsor: Shandong Branden Med.Device Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Hainan Cancer Hospital
First posted: 2023-05-23
Enrollment: 1666
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: In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 18 years old;
* Patients who follow medical advice and require PICC catheterization;
* Patients who have not participated in other clinical studies;
* Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
* There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block

Exclusion Criteria:

* Known allergies to catheter materials;
* There is a history of infection, injury, and radiation therapy at the puncture site;
* The puncture site has a history of venous thrombosis or surgery;
* Severe abnormal coagulation function;
* Superior vena cava compression syndrome;
* Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
* Heart pacemaker and arteriovenous fistula on the same side of the limb;
* Patients or patients' family members refuse to sign the informed consent form.

Primary outcomes:
measure: rate of complications
timeFrame: 120 days after operation
Secondary outcomes:
measure: time of catheter retention
timeFrame: 7, 30, 60, 90 and 120 days after operation
Other outcomes:
measure: rate of unplanned extubation
timeFrame: 7, 30, 60, 90 and 120 days after operation
measure: Success rate of one-time catheterization
timeFrame: 7, 30, 60, 90 and 120 days after operation
measure: Operation time
timeFrame: Immediately after operation
measure: incidence of difficulty in pulling out the tube
timeFrame: 7, 30, 60, 90 and 120 days after operation
Locations:
Study officials:
References:
Clinical trial NCT04216849: Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
Official title: Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes With Renal Manifestations
Keywords: human umbilical cord mesenchymal stem cells
type 2 diabetic nephropathy
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2020-01-03
Enrollment: 54
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.

Detailed description: The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects，which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5\*10\^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.

Eligibility criteria: Inclusion Criteria (in brief):

* Type 2 diabetes mellitus
* Diabetes duration≤20 years
* 18.5kg/m\^2 ≤ BMI\< 30 kg/m\^2
* 7.5%≤HbA1C≤10%
* UACR≥30mg/gCr
* eGFR ≥45/milliliter/1.73m\^2

Exclusion Criteria (in brief):

* Type 1 diabetes mellitus
* tumor history
* Other causes of chronic kidney disease
* Abnormal liver function

Primary outcomes:
measure: UACR
timeFrame: 48weeks after treatment
Secondary outcomes:
measure: HbA1c
timeFrame: 48weeks after treatment
measure: insulin/C peptide
timeFrame: 48weeks after treatment
measure: insulin dosage
timeFrame: 48weeks after treatment
measure: eGFR
timeFrame: 48weeks after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital, Shanghai Tongji University
name: Zhongming Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04309149: Market Research - Acceptability Study for a Range of MCT Products
Official title: Market Research - Acceptability Study for a Range of New MCT Based Products (Dr Schär - Kanso MCT) Kanso MCT 100% Oil Kanso MCT 77% Oil Kanso MCT 83% Margarine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketosis
Epilepsy
Ketogenic Diet
Fatty Acid Oxidation Disorder
Malabsorption
Lead sponsor: Dr. Schär AG / SPA
Sponsor class: INDUSTRY
First posted: 2020-03-16
Enrollment: 12
Sex: ALL
Minimum age (years): 2
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a market research, observational study to evaluate the tolerability and acceptability of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation disorder, which requires a specialist diet including MCT will be included in this study


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy or a fatty acid oxidation disorder requiring a ketogenic or a specialist diet as part of their treatment, which includes MCT.
* Subjects who are new to or already taking an MCT oil and are willing to try each of the 3 study products for 7 days each. 21 days taking product with 2 days between new product trialled.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from patient or parental caregiver.

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.

Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: 7 days for each product, maximum 25 days
measure: Product compliance
timeFrame: 7 days for each product, maximum 25 days
measure: Product palatability
timeFrame: 7 days for each product, maximum 25 days
measure: Product acceptability
timeFrame: 7 days for each product, maximum 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Bristol Royal Hospital for Children
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
Study officials:
References:
Clinical trial NCT04080349: Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery
Official title: Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women Delivered Only by Cesarean Delivery:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: IUD Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in women delivered only by cesarean section.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* women delivered only by elective cesarean section and not received analgesics in the last 24 hours

Exclusion Criteria:

* contraindications to dinoprostone or misoprostol or IUD insertion and allergy to study drugs.

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01854749: S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Official title: S1 Combined With Cisplatin in Treatment of Recurrence/Metastasis of ESCC Open-label Single Center Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: ESCC
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the efficacy and safety of S1 combined with cisplatin in treatment of recurrence/metastasis of ESCC


Eligibility criteria: Inclusion Criteria

* Joined the study voluntarily and signed informed consent form;
* Age 18-75

  .Presence of at least one index lesion measurable by CT scan or MRI
* recurrence/metastasis of Esophageal carcinoma or gastroesophageal cancer confirmed by pathology
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* PS ECOG 0-1
* Life expectancy of more than 3 months
* ANC≥2×109/L，PLT≥100×109/L，Hb≥90g/L

  * Cr≤1.0×UNL
  * TBIL≤1.25×UNL； ALT/AST≤2.5×UNL，with hepatic metastases ALT/AST≤5.0×UNL；AKP≤2.5×UNL

Exclusion Criteria:

* there is radical cure of the cancer

  * uncontrolled chronic diarrhea and esophageal obstruction
  * Neurological or mental abnormalities Influence of cognitive ability include central nervous system metastases
  * Severe complication(s), e.g.,uncontrolled active infection,myocardial infarction,hypertension,arrhythmia,stenocardia
  * Patient who has metastasis except cured skin basal cell carcinoma and carcinoma in situ of cervix
* accept other antitumor therapy •Female patients during their pregnant and lactation period, or patients without contraception

Primary outcomes:
measure: Progression Free Survival
timeFrame: from the first cycle of treatment (day one) to two month after the last cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer hospital Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04870749: The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.
Official title: Diagnostic Role of Visual Prostate Symptom Score and Intravesical Prostatic Protrusion in Male Lower Urinary Tract Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Obstruction
Keywords: IPP
IPSS
VPSS
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 219
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients over 50 years old who applied to Sivas Cumhuriyet University Hospital urology outpatient clinic between March 2020 and August 2020.

Brief summary: The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Detailed description: Aims The diagnosis of bladder outlet obstruction is made by pressure-flow studies, which is an invasive method. This study was conducted to evaluate non-invasive, effective, and low-cost diagnostic methods in male patients with bladder filling and emptying abnormalities.

Methods The study included 219 male patients aged 50 and over, who were admitted between March 2020 and August 2020. Patients completed the Visual Prostate Symptom Score (VPSS) along with International Prostate Symptom Score (IPSS). Intravesical prostatic protrusion (IPP), prostate volume, bladder volume, and post voiding residual urine (PVR) were measured by suprapubic ultrasound. Urethral resistance was calculated using the Bladder Outlet Obstruction Number (BOON), and patients over -20 were considered obstructed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of BPH Disease

Exclusion Criteria:

* Patients with previous urological surgery
* History of urological malignancy
* Systemic disease (diabetes mellitus, multiple sclerosis, etc.)
* Trauma that may cause LUTS
* Pharmacotherapy for LUTS
* Use diuretic antihypertensive
* PSA \> 4 ng/dl
* History of pelvic radiotherapy
* Visual problems that could not complete the VPSS test were not included.

Primary outcomes:
measure: The Importance of Non-invasive Methods in the Diagnosis of Lower Urinary System Symptoms.
timeFrame: During the patient's outpatient clinic examination
Secondary outcomes:
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet Universty
Study officials:
References:
Clinical trial NCT03902249: Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
Official title: Effect of Intravenous Dexamethasone in Combination With Pudendal Nerve Block on Postoperative Pain Control in Pediatric Hypospadias Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Hypospadias
Keywords: Intravenous Dexamethasone
Pudendal nerve block
Analgesia
Postoperative pain
Children
Hypospadias
Lead sponsor: Hôpital d'enfants Béchir-Hamza
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 70
Sex: MALE
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to determine if intravenous Dexamethasone combined with a pudendal nerve block is able to prolong postoperative analgesia in children undergoing hypospadias repair.

Detailed description: It was a prospective study, randomized, double blind study, conducted at the Tunis Children's Hospital (January 2017-December 2018). After agreement with parents and the local ethics committee, the investigators included children aged 1 to 18 years, ASA 1-2, proposed for a hypospadias repair. Patients were randomized to: Group D receiving 0. 15mg/kg of Dexamethasone IV after induction and group P receiving the same volume of saline. The pudendal block was performed by neurostimulation after induction with Sevoflurane and 3 gamma/kg Fentanyl IV. The success of the block was tested at 10 and 15 minutes, it was declared successful when the systolic blood pressure and heart rate did not increase by more than 20% compared to the baseline values at the time of the incision. No analgesics were administered at the end of the surgery. The pain was assessed by the CHEOPS score the first 24 hours. The X2 test was used for qualitative variables and the student test for quantitative variables with P\<0. 05 as the significance threshold. The number of patients required for the study was calculated (alpha=5% beta=90%) and was 62.

Eligibility criteria: Inclusion Criteria:

* ASA physical status classification 1 or 2
* Procedure: hypospadias repair
* Eligible for a pudendal nerve block

Exclusion Criteria:

* parents or patient refusal
* nerve block failure
* Peroperative complication.

Primary outcomes:
measure: The mean time to first rescue analgesic
timeFrame: The first 24 hours after surgery
measure: number of rescue analgesic consumption
timeFrame: The first 24 hours after surgery
Secondary outcomes:
measure: pain scores (CHEOPS)
timeFrame: Hour 0, Hour 1, Hour 2, Hour 3, Hour 4, Hour 8, Hour 12, Hour 24
measure: Number of episodes of postoperative nausea and vomiting
timeFrame: The first 24 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02530749: Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients
Official title: Frailty as a Predictor of Neurosurgical Outcomes in Brain Tumor Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Tumors
Keywords: Surgery
Frailty
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 265
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes patients 18 years and older with a history of brain tumor scheduled for elective resection of tumor. Patients have to be ambulatory and be able to complete the examination and obtain a Hopkins Frailty Score.

Brief summary: Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Detailed description: Preoperative risk assessment is important, but inexact, in older patients because physiologic reserves are difficult to measure. This also makes an important difference related to brain tumor patients, who may be burdened with systemic disease, alterations in cognition, or affected by other comorbidities. When assessing quality of life for brain tumor patients, having a better predictor of postsurgical outcome would be beneficial in appropriately counseling these patients. Frailty is thought to estimate physiologic reserves, and its use has been found to predict postoperative complications, length of stay, and discharge to a skilled or assisted-living facility in neurosurgical patients. Frailty as an adjunct to preoperative assessment of neurosurgical patients has never been evaluated. This study aims to determine if frailty predicts neurosurgical complications in brain tumor patients and enhances current perioperative risk models.

Eligibility criteria: Inclusion Criteria:

* Adult
* Ambulatory (able to walk)
* Scheduled for neurosurgical resection of brain tumor

Exclusion Criteria:

* Parkinson disease
* Previous stroke
* Taking: carbidopa/levodopa, donepezil hydrochloride, or antidepressants

Primary outcomes:
measure: Number of patients with a Complication risk
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay based on a Hopkins Frailty Score (HFS).
timeFrame: 30 days
measure: Number of patients Discharge to a skilled or assisted-living facility
timeFrame: 30 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: D. R. Ormond, MD
role: PRINCIPAL_INVESTIGATOR
References: