cyrilzakka/clinical-trials huggingface dataset:
A Water-based Sequential Preparatory Approach and Stroke

Many studies hypothesize that people who have suffered stroke could benefit from water-based exercises to improve their strength and ability to perform the activities of daily living.

A Cochrane Review systematically synthesized and compared the effects of aquatic and land-based therapies on the activities of daily living (ADL) of patients following stroke and found that water-based exercises improved strength and ADL. A recent review indicates that RCTs comparing aquatic methods in both environments are lacking. The same movements in water and on dry land that target postural stability and gait require different competences. For example, the postural instability that occurs while squatting in water was enacted on land by sitting on a therapy ball. Furthermore, land-based conventional rehabilitation is generally task oriented, customized and challenging and follows a specific preparatory sequence of exercises according to patients' disabilities. Therefore, the investigators believe that a sequential preparatory approach (SPA), based on increasing difficulty and following a specific sequence of preparatory exercises (from the simplest to the most complex), should also be used in an aquatic environment.


Eligibility Criteria:
Inclusion Criteria:

* Stroke with unilateral hemiplegia within the previous six months;
* Ability to walk without any device or need of continuous physical assistance to support body weight or maintain balance (Functional Ambulation Classification ≥ 3);
* Acclimatization to water.

Exclusion criteria:

* Cognitive deficits affecting the ability to understand task instructions (Mini-Mental State Examination \> 24);
* Severe unilateral spatial neglect (diagnosed with a test battery that included the Letter Cancellation test, Barrage test, Sentence Reading test and the Wundt-Jastrow Area Illusion Test);
* Severe aphasia (diagnosed by means of neuropsychological assessment);
* Presence of other neurological diseases;
* Presence of cutaneous and mycosis infections;
* Presence of open wounds, eczema, skin ulcers, decubitus lesions, severe burns;
* Presence of PEG (Percutaneous endoscopic gastrostomy);
* Presence of tracheostomy;
* Urinary incontinence;
* Presence of otitis
* Presence of orthopedic or cardiac comorbidities that would limit participation in the experimental and conventional training (all of which were clinically evaluated).
Healthcare Access and Utilization Among Living Kidney Donors

This is a mailed survey to persons who served as living kidney donors at Saint Barnabas Medical Center. The experimental component of this study (the clinical trial) is a randomized trial of two monetary incentives for the living kidney donors invited to participate in the study. Kidney donors will be randomized to receive one of two incentives in the mailed survey packet: $2 cash vs. $5 cash. The main outcome measure is the response rate to the survey.


Eligibility Criteria:
Inclusion Criteria:

* Persons who donated a living donor kidney at Saint Barnabas Medical Center between January 2000 and December 2006 are eligible to participate

Exclusion Criteria:

* Current address outside the continental United States
* Persons who donated a living donor kidney prior to January 2000 or after December 2006
* Persons who indicated they no longer wished to be contacted by Saint Barnabas Medical Center
Acupoint Stimulation Improves Fatigue and Sleep Quality in Patients With Postdialysis

Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. However, long-term dialysis can lead to fatigue and decreased sleep quality. Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear.

This study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.

Hemodialysis is a necessary treatment to prolong the lives of patients with end-stage kidney disease. However, long-term dialysis can lead to fatigue and decreased sleep quality. Acupoint stimulation can regulate meridians and improve physical function. Nevertheless, the effectiveness of low-level laser stimulation on fatigue and sleep quality in hemodialysis patients remains unclear.

This study is designed to use low-level laser stimulation as an intervention measure to evaluate its effectiveness in improving fatigue and sleep quality in hemodialysis patients.

The experimental group will receive low-level laser stimulation on seven acupoints, including Shenmen (HT7), Neiguan (PC6), Hegu (LI4), Zusanli (ST36), Yanglingquan (GB34), Sanyinjiao (SP6), and Taixi (KI3). The stimulation will be administered three times per week for a duration of six weeks. The control group will receive sham low-level laser stimulation on the acupoints, without emitting laser beams.

Before and after each intervention, fatigue will be measured using a visual analog scale for a total of 18 measurements. Additionally, at baseline and at the 2nd, 4th, and 6th weeks, the hemodialysis patients will be assessed using the Fatigue Scale for Hemodialysis Patients, Dialysis Recovery Time Scale, Pittsburgh Sleep Quality Index, Dialysis Symptom Index, and Beck Depression Inventory.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 20 years and above.
2. Diagnosed with end-stage kidney disease and receiving regular outpatient hemodialysis three times a week for at least three months.
3. Conscious and capable of communication in Mandarin or Taiwanese (Hokkien).
4. Willing to participate in this study and have signed the informed consent form.

Exclusion Criteria:

1. Presence of skin lesions or infectious wounds at the acupoint locations.
2. Taking immunosuppressive medication.
3. Photosensitivity or sensitivity to light.
4. Individuals with implanted cardiac pacemakers.
5. Patients using sleep medication.
Children's Blood Draws: Lavender Study

The aim of this study is to show the effect of lavender scent used to reduce pain and fear during blood collection in children aged 7-14.

The children in the experimental group were given lavender scent before the blood collection procedure. No additional intervention was made to the children in the control group. The pain and fear scores of both groups were evaluated.

Eligibility Criteria:
Inclusion Criteria:

children between the ages of 7-14 who applied to the blood collection unit, who had no mental neurological, hearing, speech, vison disorders

Exclusion Criteria:

who were not allergic to lavender essence, who were not diagnosed with asthma, allergies, epilepsy, dermatitis who had not taken analgesics in the last 6 hours were included in the study
A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics

This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
3. Signed informed consent.

Exclusion Criteria:

1. Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
2. Having deep vein thrombosis or other thrombotic diseases.
3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
4. Extended QT interval during the screening period (calculated in Bazett's method, males \>450 msec)
5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
6. Those who have a history of allergies to drugs , food or test drugs or similar drugs;
7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
8. Those who took any drug within 14 days before the test (including Chinese herbal medicine)
9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test
10. Subjects have participated in other clinical trial within the 3 months prior to study entry.
11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.
Promoting Cholesterol Screening

Cholesterol screening is an important prerequisite for cardiovascular disease (CVD) risk assessment. Cholesterol screening is recommended by the United States Preventive Services Task Force (USPSTF). Since reminder systems have been shown to modestly improve the rates of preventive services, including in safety net settings, we will implement patient-directed reminders to health center patients who meet our eligibility criteria.

The aim of this study is to determine if a mailed outreach message and facilitated ordering of screening lipid tests increases cholesterol screening test completion within 3 months among federally qualified community health center patients who are eligible for screening compared to usual care.


Eligibility Criteria:
Inclusion Criteria:

* Patient at participating health center
* At least 1 visit to clinic in the prior 12 months
* No total cholesterol and high-density lipoprotein cholesterol result recorded in the electronic health record in the past 5 years
* No cholesterol screening order placed within the previous 3 months
* Men 35-75 years old, or women 45-75 years old who also have one of the following: hypertension, obesity, or current smoking

Exclusion Criteria:

* Previously diagnosed cardiovascular disease, peripheral arterial disease or diabetes mellitus
* Statin on active medication list
* Preferred language other than English or Spanish
A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children.

Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Children are randomized to receive HIVIG every 4 weeks for 6 months at one of three dose levels, then are followed for 3 months after the final infusion.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Required:

* PCP prophylaxis according to CDC guidelines.

Allowed:

* Varicella-zoster immunoglobulin.
* Hepatitis B immunoglobulin.
* Prophylactic therapies not involving immunoglobulin.

Patients must have:

* HIV infection.
* CD4 count \> 200 cells/mm3 (ages 2-5 years) or \> 100 cells/mm3 (age \> 5 years).
* Antiretroviral therapy for at least 6 months, with no change in regimen for at least 3 months prior to study entry.
* Plasma ICD p24 \>= 70 pg/ml that is stable or increasing prior to study entry.
* Life expectancy of at least 6 months.

Prior Medication: Required:

* Antiretroviral therapy for at least 6 months, with stable dose for at least 3 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Severe diarrhea, nephrotic syndrome, or other protein-losing state that requires large doses of IVIG.
* Any other condition requiring dosing with IVIG (e.g., ITP, hypogammaglobulinemia).
* Acute illness with temperature \>= 100 F and/or with IV antibiotics.
* Grade 3 or worse clinical toxicities.
* Unable to tolerate IV infusions at a minimum rate of 0.02 ml/kg/min.
* Concomitant participation in an experimental antiretroviral or HIV vaccine trial.

Concurrent Medication:

Excluded:

* IVIG.
* Chemotherapy for an active malignancy.
* MMR or rubella vaccinations.
* Intramuscular immunoglobulin.

Patients with the following prior condition are excluded:

* History of severe reaction to IVIG.

Prior Medication:

Excluded:

* IVIG within the past 60 days.
* Chemotherapy for an active malignancy within the past year.
* MMR or rubella vaccinations within the past 6 months.
* Intramuscular immunoglobulin within the past 60 days.

Ongoing drug or alcohol abuse.
Real-time Diagnosis of Diminutive Colorectal Polyps Using AI

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis.

Multiple machine learning techniques - computer-aided diagnosis (CADx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps.

Aim of this study is to explore the feasibility of the workflow using AI4CRP (a CNN based CADx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of AI4CRP for the diagnosis of diminutive (\<5mm) colorectal polyps. Secondary, the real-time performance of commercially available CADx systems will be investigated and compared with AI4CRP performance.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years;
* Patients with at least one colorectal polyps encountered during colonoscopy;
* Patients referred for a colonoscopy by the Dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints;
* Written informed consent.

Exclusion Criteria:

* Patients with prior history of inflammatory bowel diseases (IBD) or polyposis syndromes;
* Patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist;
* Patients undergoing an emergency colonoscopy;
* Written objection in the patient file for participation in scientific research.
Prevalence of Acute Hepatic Porphyria

To determine the proportion of patients suffering from acute hepatic porphyria (AHP) from different hospital departments and referred to an internist referent for a suggestive clinical picture with a first negative etiological assessment.

In this context, this study aims to assess the prevalence of PHA in a population of patients with a suggestive clinical picture. A better knowledge of the pathology will make it possible to better guide patients and prevent them from diagnostic wandering fraught with physical and psychological consequences.

This is an observational, ambispective, transversal, multicenter study carried out in France. The goal is to recruit a cohort that will reflect current practice. 500 patients will be recruted.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 to 60;
* Presenting severe abdominal pain, afebrile and diffuse over several days, evolving for less than 5 years;
* With at least one of the following symptoms:

  * Peripheral neurological symptoms: decreased driving force and pain in the limbs (roots of the thighs), etc. ;
  * Central neurological symptoms: psychiatric (depression, anxiety, insomnia), disturbances of consciousness, etc. ;
  * Autonomous neurological symptoms: tachycardia, nausea, vomiting, constipation, etc.
* With a first negative etiological assessment requested by an emergency physician, gastroenterologist, gynecologist, neurologist, internist or another specialty, or with a diagnosis of acute hepatic porphyria less than 6 months;
* Patient able to understand the information related to the study and having indicated his non-objection to the collection of data concerning him;

Exclusion Criteria:

* Patient with a diagnosis of acute hepatic porphyria for more than 6 months;
* Patient unfit to participate in the study, due to cognitive or linguistic difficulties;
* Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision).
Shivering Treatment After Cesarean Delivery: Meperidine vs. Dexmedetomidine

Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.

It is a double blinded randomized control trial.

Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan

Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes

Control group: meperidine 0.35 mg/kg IV in 2 minutes

Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug

Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis.

The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Term \> 37 weeks
* American Society of Anesthesiologists Physical Status (ASA PS) I, II
* Weight \< 115 kg
* Functional epidural in situ
* In labor requiring cesarean delivery
* Class III or IV shivering on the Crossley and Mahajan standardized shivering scale between five minutes after the baby's birth to the end of the cesarean section

Exclusion Criteria:

* Refusal of the patient and/or the anesthesiologist
* Misunderstanding of the protocol
* Known allergy or contraindication to one of the study drugs
* Emergency cesarean delivery
* American Society of Anesthesiologists Physical Status III, IV, V
* Severe heart, liver or kidney disease,
* Preeclampsia
* Patient taking monoamine oxydase inhibitors
* Sleep apnea
* General anesthesia
Link of Interest and Training Model

* The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view.
* Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation.
* But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.

* Objective: Using the example of Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC), the investigators analyze the development model of this procedure and provide an ethical analysis of the involvement of the industry in this development.
* Summary Background Data: In the case of breakthrough innovation, medical training is essential for safe use of the new procedure. Pharmaceutical companies may organize this training; but when it becomes the only training opportunity to use the device, scientists and clinicians are exposed to a conflict of interest.
* Methods: The investigators performed a literature review of PIPAC publications using the STROBE criteria. Then, the investigators conducted interviews with an expert panel to analyze the ethical impact of involvement of the industry in the development of the PIPAC procedure.

Eligibility Criteria:
Inclusion Criteria:

* expert in pipac
* more than 30 PIPAC per year

Exclusion Criteria:

-
The Effect of Low-İntensity Combined Exercises in Patients With Early Stage ALS.

The aim of this study is to investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life applied to patients with ALS.

Balance problems and signs of fatigue are seen in early-stage ALS patients. While balance problems lead to falls in ALS patients, fatigue also affects a part of their lives. Studies investigating the effects of low-intensity exercise on fatigue, balance, and quality of life in patients with early-stage ALS are rare. This study will investigate the effects of low-intensity combined exercises on balance, fatigue and quality of life in patients with ALS.

Participants will be randomly divided into Supervised and Home groups. Low-intensity exercises will be applied to the home exercise group as a home program for 1 hour a day, 3 days a week, for 6 weeks. Low-intensity exercises will be applied to the supervised exercise group for 1 hour a day, 3 days a week for 6 weeks, accompanied by a physiotherapist. Evaluations will be made at the beginning and at the end of the treatment.

Berg Balance Scale, Fatigue Severity Scale (FSS), Amyotrophic Lateral Sclerosis Assessment Questionnaire-40 (ALSAQ-40) and revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) will be used to evaluate patients before and 6 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with early-stage ALS by a neurologist
* Disease duration in the range of 1-18 months
* ALSFRS-R score \> 24 higher
* Without infectious disease
* Saturation \>95
* Heart rate \<92

Exclusion Criteria:

* History of other neurological disease
* Inability to walk
* With mechanical ventilation
* People with Heart and Respiratory Insufficiency
* People with neuropsychological or cognitive impairment
* Dyspnea after ALS
The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.

Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.

This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair.

The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not.

The short and long term outcomes between both groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Hypospadias Patient
* Recurrent Cases
* 6 months or more
* Distal, and mid penile hypospadias

Exclusion Criteria:

* None