cyrilzakka/clinical-trials huggingface dataset:
Exercise in Peritoneal Dialysis Patients (PDEX)

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. The aim of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary measures included physical function measures and patient-reported outcome measures (PROMs)

Patients with end-stage kidney disease (ESKD) receiving peritoneal dialysis (PD) are physically inactive, resulting in poor physical function and reduced quality of life. Combined resistance and cardiovascular exercise programs have been shown to be successful in hemodialysis patients but studies are limited in PD patients. The primary objectives of this pilot trial was to test the study feasibility of a combined resistance and cardiovascular exercise program (recruitment and retention rates) and report adherence and adverse events. Secondary objectives were to calculate the sample size for detecting differences in the 30 second sit to stand test (STS30) and measure the effect on physical function and patient reported outcome measures (PROMs).

Methods: The 3-month parallel two-arm pilot trial took place in California, USA. All participants were peritoneal dialysis patients in a single center who met inclusion criteria were invited into a randomized controlled trial. Recruitment was through face to face invitation following eligibility requirements. The intervention (I) group received monthly exercise physiologist consultations, exercise prescription (resistance and aerobic exercise program using exercise bands) and weekly phone calls over 12 weeks. Control (C) group received normal care. Feasibility outcomes were exercise adherence rates and adverse events. Secondary physical function measures were change in I compared to the C group in STS30, pinch strength test (PST) and the 8 foot timed up and go test (8TUG). PROMs were measured using the London Evaluation of Illness (LEVIL) instrument. Data collection was not blinded but statistical analysis was blinded.

Eligibility Criteria:
Inclusion Criteria:

* end-stage kidney disease
* receiving peritoneal dialysis for greater than 6 weeks
* approved by the center Medical Director

Exclusion Criteria:

* unable to understand English
* previous major amputations
* unable to ambulate independently
* known to be pregnant
Gustatory Dysfunction Among a Sample of Depressed Egyptian Adults Under Anti-depressants Therapy

- Assess gustatory thresholds among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using filter paper disc(FPD) method through a scoring system. - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify possible modulators for developing gustatory dysfunction among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

PECO

* P Population: depressed Egyptian adults under anti-depressants therapy
* E1 Exposure 1: commonly prescribed tricyclic antidepressants (Imipramine, Amitriptyline, Clomipramine HCL)
* E2 Exposure 2: commonly prescribed Selective Serotonin Re-uptake inhibitors antidepressants ( Fluoxetine, Fluvoxamine, Sertraline, Citalopram, Paroxetine)
* C control (non exposure) : non-pharmacological treatment ( psychotherapy)
* O Outcome:

Primary 1ry : Assess gustatory thresholds among a sample of depressed Egyptian adults (age from 20 to 50 years old) under anti-depressants therapy ( for at least 3 months) using filter paper disc(FPD) method through a scoring system.

Secondary 2ry: - Determine the taste intensity at supra-threshold among these patients using a psychophysical method through a scoring system. - Identify gustatory dysfunction modulators among these patients using a questionnaire ( appendix) with a binary measuring unit (yes/no).

Eligibility Criteria:
Inclusion Criteria:

* Depressed Egyptian adults under antidepressants therapy for at least 3 months/non-pharmacological treatment( psychotherapy)
* Age from 20 to 50 years old

Exclusion Criteria:

* Antipsychotics
* Hypnotics
* Anticonvulsants
* Ages other than the mentioned
* Olfactory dysfunction
* Chemosensory dysfunction
Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.


Eligibility Criteria:
Major Inclusion Criteria:

* Scheduled for non-emergent, hepatic surgery
* Presence of an appropriate target bleeding site (TBS) as defined by the protocol

Major Exclusion Criteria:

* Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar
* In subjects with documented history of cirrhosis, subject has uncorrected platelet count \<60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery
* Subject has severe coagulopathy defined as INR \> 2.0
* Subject has Total Bilirubin \>2.5mg/dL
* Subject has an active local infection at the Target Bleeding Site
* Study procedure involves a liver transplant recipient
Myomectomy During Cesarean Section Is This Aright Decision

myomectomy was done during cesarean section

The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.

Eligibility Criteria:
Inclusion Criteria:

* women with diagnosed uterine myoma prior to pregnancy
* needed cesarean sections for various indications.
* Women with diagnosed uterine myoma during pregnancy and needed cesarean sections for various indications.
* Women with myoma diagnosed incidentally during labour.

Exclusion Criteria:

* Refusal of the women at any time before and during the operations.
* Cervical myoma.
* Atonic uterus after delivery of the baby.
* Women with bleeding disorders due to medical or obstetric causes.
Effects of a CBD and Natural Ingredients Cream on the Chronic Pain of Triathletes, Runners, Cyclists, and Swimmers

There is a high prevalence of chronic pain in our society, which is detrimental at an individual and country level. Cannabidiol (CBD) has been proposed as a promising treatment for chronic pain, although more high-quality studies are needed in this area. On the other hand, triathlon, running, cycling, and swimming are sports modalities that have an increasing professionalism and importance, albeit not exempt from injuries.

The main goal of this study is to assess the effectiveness of a topical treatment for recurrent chronic pain caused by tendinopathies with a cream containing CBD in triathletes, runners, cyclists, and swimmers. Consequently, the research question for this study is the following: Can the CBD cream be effective in treating chronic pain? The investigators hypothesize that the cream will be able to affect the pain, both in the short and the long term.

The study will be interventional, with a crossover, randomized, and double-blinded design. Two groups of participants will be generated, as well as two treatment options (CBD cream, and a similar one without the CBD). The subjects will apply one of the treatments for one month, followed by a wash-out week without any cream application, and another month with the other treatment. During these weeks, different parameters will be controlled via online questionnaires.

The analyzed variables will include the following: Chronic pain, acute pain, wellness, perceived exertion, quality of life, and satisfaction with the treatment. Different statistical tests will be applied to the collected data, comparing their means and correlations to infer the results.


Eligibility Criteria:
Inclusion Criteria:

* Being a federated triathlete, runner, cyclist, or swimmer.
* Being 18-70 years old.
* Having chronic pain (present at least 3 months before the beginning of the study).
* Having a diagnosis of patellar, Achilles, or iliotibial band tendinopathy for the lower extremities, and/or shoulder rotator cuff or biceps brachii tendinopathy for the upper extremities.
* Training any modality of triathlon, running, cycling, or swimming 4-5 days per week with a minimal training volume of 8 hours per week.
* Having at least 1 year of experience training in triathlon, running, cycling, or swimming.
* Providing at least 80% of the needed data for the study.

Exclusion Criteria:

* Pregnant women.
* People allergic to any of the ingredients of the creams used.
* People with skin injuries in the zones in which the cream has to be applied.
* Using any other pain treatments. Those who use them before the study can still participate if they stop their usage 1 week before the beginning of the study.
Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

This is a prospective, multicenter, randomized study designed to enroll 138 patients with superficial femoral artery stenosis and /or occlusion who will be randomized 1:1 to be treated with the Drug eluting peripheral vascular stent system versus the commercially available Nitinol Stent System (Cordis Corporation). Patients will receive Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging at 6th month and 12th month post procedure. Clinical visits are scheduled at 0\~30 days, 6 months, 12 months, and telephone visits are scheduled at 1 month, 3months, and 9 months. Furthermore, CDU will also be performed at baseline in all participants of the study.

Eligibility Criteria:
Inclusion Criteria in Preoperative:

* Aged from 18 to 85 years old, male or female
* Subject's target lesions were stenosis and/or occlusion
* Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent

Exclusion Criteria in Preoperative:

* In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration
* Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration
* Subject with coagulation abnormalities should not be performed
The Efficacy and Safety of Using Tranexamic Acid to Reduce Blood Loss In Simultaneous Bilateral Total Knee Arthroplasty

A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty.

A randomized, double-blind, single-center and controlled study comparing the efficacy and safety of intravenous administration of tranexamic acid to reduce blood loss in simultaneous bilateral total knee arthroplasty. Subjects will be monitored for occurrence of any complications, particularly deep venous thrombosis and thromboembolism during the hospital stay and for 1 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who plan to undergo simultaneous primary total knee arthroplasty on bilateral knee joint with a diagnosis of osteoarthritis or aseptic bone necrosis, but not of rheumatoid arthritis;
* All patients who have normal preoperative platelet count, normal prothrombin time, normal partial thromboplastin time, and normal international normalized ratio;
* The use of only balanced electrolyte solutions and/or albumin for plasma volume restitution

Exclusion Criteria:

* Allergy to tranexamic acid;
* Receiving warfarin or heparin; had a history of hemophilia, deep venous thrombosis, pulmonary embolism, or renal impairment; or were pregnant;
* Patients with any cardiovascular problems (such as myocardiac infarction history, atrial fibrillation, angina);
* Patients with thromboembolic disorders, or those exhibiting a deteriorating general condition;
* Preoperative anemia (a hemoglobin value of \<11 g/dL in females and \<12 g/dL in males), refusal of blood products;
* Preoperative use of anticoagulant therapy within five days before surgery, fibrinolytic disorders requiring intraoperative antifibrinolytic treatment, coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \[\>1.4 times normal\]).
Project BEST: Buprenorphine Entry Into Substance Abuse Treatment

Project BEST is a clinical project funded by the Substance Abuse and Mental Health Services Administration (SAMHSA) to increase treatment to opiate dependent patients with mental illness in New Haven, CT and to prospectively follow everyone enrolled in buprenorphine care for as long as the individual takes buprenorphine to track the success of buprenorphine for the maintenance of opiate dependence.

The investigators propose to create a prospective cohort that will track outcomes for an opiate dependent population on buprenorphine maintenance. Individuals who have already decided to undergo buprenorphine treatment in Project BEST will be invited to participate in the following data collection process. The investigators propose the following series of data collection to assess clients during their time in the cohort:

GPRA, supplemental instrument, ASI, SCID, COWS, Urine toxicology.

Patients who are enrolled will enter a standardized, manual based weekly counseling regimen. Urine toxicology will be performed a minimum of twice monthly, but will not occur at the same times monthly to decrease the probability of sampling error.

This is a prospective cohort to follow a group of individuals on buprenorphine treatment. The goal of this prospective cohort is to generate thoughtful observations. Specific items of interest which will be compared with age, race matched historical controls on methadone will be:

1. Changes in addiction severity over treatment time
2. Changes in sexual risk behaviors and injection practices
3. Improvements in urine toxicology
4. Co-occurring mental illness

Eligibility Criteria:
Inclusion Criteria:

* Opiate dependent by DSM IV criteria - to be determined by clinician - on buprenorphine through the Project BEST Program.

Exclusion Criteria:

* Inability to adhere to study instruments.
An Observational Study of BOTOX® as Headache Prophylaxis for Chronic Migraine

This is an observational study to describe the long term use of Onabotulinumtoxin A (BOTOX®) as prescribed by the physician for headache prophylaxis in adults with chronic migraine. All treatment decisions lie with the physician.


Eligibility Criteria:
Inclusion Criteria:

- Prescribed BOTOX® for the prophylaxis of headaches.

Exclusion Criteria:

* Received treatment with any botulinum toxin Type A serotype in the last 26 weeks
* Current participation in Allergan's Botox Chronic Migraine Post-Authorisation Safety Study (protocol 191622-110).
Arterial pH Selectively Predicts Intensive Care Unit Transfer From the Emergency Department in Obese Patients With Acute Dyspnea

This study evaluates the prognostic value of arterial blood gas analysis in a cohort of Emergency Department patients presenting with shortness of breath of any cause, comparing obese and non-obese patients.

Factors associated with admission to intensive care unit (ICU) or ED mortality before transfer to the ICU are analyzed in obese (BMI ≥ 30kg.m-2) and non-obese patients subgroups.

Eligibility Criteria:
Inclusion Criteria:

* patients who presented with acute dyspnea in the ED
* patients who had an ABG analysis as part of the ED standard management

Exclusion Criteria:

* Patients with treatment limitation decisions made by the medical teams against ICU admission, including severe cognitive impairment or palliative care ,
* Patients with immediate transfer to ICU due to shock and hemodynamic instability at ED admission
Veın Imagıng Devıce And Vırtual Realıty

The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.

The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 4-10
* The child agrees to voluntarily participate in the study.
* Parents agree to voluntarily participate in the study
* Obtaining consent from the child and parent

Exclusion Criteria:

* Need for urgent resuscitation
* Having a fever (\>37.5C) and severe dehydration
* The fact that the patient had taken analgesics before the PIC intervention.
Preservation of Spontaneous Breathing in Patients Undergoing Thoracoscopic Surgery

the aim of this study is to evaluate the advantages of the non-intubation compared with intubation anesthesia on enhanced recovery after thoracoscopic surgery

All patients will be screened to determine eligibility for study entry, and the patients who meet the eligibility requirements will be informed about the study and potential risks. After giving written informed consent, The patients were randomly divided into non-intubation group and intubation group

Eligibility Criteria:
Inclusion Criteria:

* age 18-69 years old
* Body mass index (BMI) was 18-24 kg / m2
* American Society of Anesthesiologists' physical classification class I-II
* The preoperative pulmonary function was normal

Exclusion Criteria:

* Severe cardiopulmonary disease
* Severe nervous system diseases
* Severe blood system diseases
* Severe liver and kidney dysfunction
* Conversion to thoracotomy
Acupuncture in the Regulation of Dai Meridian for the Metabolism of Visceral Adipose Tissue in Abdominal Obese Patients

To evaluate the effectiveness of acupuncture therapy combined with healthy education for patients with abdominal obesity.

This subject is a prospective, single-blind, parallel-group, randomized controlled clinical trial.120 patients with abdominal obesity are allocated into two groups with a ratio of 2:1.Randomized series was generated by computer. The allocation was concealed. Patients in the intervention group are received acupuncture therapy and healthy education. Patients in the control group are only given healthy education. The treatment in both intervention group and control group lasts for 8 weeks. Comparison of two groups of patients with abdominal fat thickness, fasting serum visfatin concentration, simple anthropometric parameters (including body weight, body mass index, waist circumference, hip circumference, waist-to-hip radio, waist-to-height radio, the percentage of body fat), fasting blood glucose, fasting insulin, glycosylated hemoglobin, fasting blood lipid (total cholesterol, triglyceride, high density lipoprotein, low density lipoprotein), uric acid, blood pressure, insulin resistance level, and obesity related lifestyle survey.

Eligibility Criteria:
Inclusion Criteria:

* Met the diagnostic criteria of abdominal obesity (waist circumference of male ≥ 90cm, waist circumference of female ≥ 80cm);
* Ultrasound viscerofatty index ≥ 3;
* Age between 18-70 years old;
* Signed informed consent voluntarily.

Exclusion Criteria:

* Secondary obesity caused by endocrine, hereditary, nervous system,or drugs;
* Within 3 months adjusted drug therapy for diabetes or hypertension or hyperlipidemia;
* undergoing other therapies for reducing body mass and waist circumference, such as surgery, medication, etc;
* participating or have participated in other studies;
* pregnant or breast-feeding women;
* critically ill, having hepatic-renal dysfunction or mental illness;
* severe impairment in sight and hearing.
Effects of HMOs on the Faecal Microbiota and on Host Metabolism in Obese Children

The study is a randomised, placebo-controlled, double-blind, parallel study in obese children. A total of 75 obese children in the age 5 to 10 years, enrolled in a childhood obesity treatment program, will be included. The participating children will be randomised into one of three groups consuming either HMO (two groups) or placebo (one group).

The primary objective of the study is to establish the effects of HMOs on the faecal microbiota in children. Secondary objectives are to evaluate safety of HMO supplementation in children and the effect on gastrointestinal symptoms (tolerance), bowel habits, metabolic profile and body composition in obese children.


Eligibility Criteria:
Inclusion Criteria:

1. Informed, written consent by the child's representative(s) and informed verbal assent by the child
2. Age ≥5 and \<11 years at visit 0
3. BMI SDS of ≥ 2.3
4. Enrolment in the childhood obesity treatment program at the Children's Obesity Clinic
5. Ability and willingness to understand and comply with the study procedures
6. The child's representative(s) need(s) to read, speak and understand Danish

Exclusion Criteria:

1. Participation in another clinical intervention study one month prior to the screening visit and throughout the study.
2. Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
3. Other severe disease(s) such as malignancy, kidney disease or neurological disease, as judged by the investigator.
4. Psychiatric disease, as judged by the investigator.
5. Use of probiotic supplements (yoghurt allowed) 3 months prior to screening and throughout the study.
6. Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
7. Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
8. Lack of suitability for participation in the study for any reason as judged by the investigator.