cyrilzakka/clinical-trials huggingface dataset:
Comparison of Three Treatments for Lower Extremity Apophysitis

The purpose of this study is to compare three different treatments for these types of lower extremity apophysitis- Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), or Sever's disease.

The investigators hypothesize that adolescents who perform a home exercise program (HEP) consisting of active elongation exercises will have decreased pain and earlier return to sports and activities as compared to those who perform a HEP that consists of static stretching exercises or those who use symptomatic treatment with ice, acetaminophen or NSAIDs and activity modification.

Osgood-Schlatter syndrome (OSS), Sinding-Larsen and Johansson syndrome (SLJ), or Sever's disease are three types of apophysitis, or secondary growth center irritation, that frequently affect children and teens. Although these conditions are common, there is very little data from high quality studies to support a particular treatment method in affected patients. The purpose of this study is to compare three different treatments for these types of apophysitis. The investigators plan to compare two types of home exercise program (HEP), one involving active elongation exercises and one utilizing static stretching, with symptomatic treatment consisting of icing, over-the-counter medications and relative rest. The investigators hypothesize that the active elongation HEP will result in improvement in pain and earlier return to athletic activities when compared to the static stretching HEP and symptomatic care. This pilot study will recruit subjects at the Ann \& Robert H. Lurie Children's Hospital outpatient sports medicine and orthopaedic clinics with any of the following types of lower extremity apophysitis: OSS, SLJ or Sever's disease. Subjects will complete a baseline evaluation and questionnaire and will be randomized into one of the three treatment groups. At 2, 4, 6, and 8 weeks, subjects from all groups will use a secure website to complete an online survey to complete questions regarding current pain level, compliance with their home exercise program, if applicable, use of other forms of treatment or pain management (e.g. splinting, icing, rest from activities) and current activity level. The investigators will compare results from each group to determine which treatment(s) resulted in the largest improvements in pain scores and the highest rates of participation in sports and recreational activities.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of OSS, SLJ, or Sever's disease
* must have regular access to the Internet

Exclusion Criteria:

* history of prior treatment for OSS, SLJ, or Sever's disease
* history of previous injury to the affected joint requiring more than 1 week off of sports or activities
Effect of Cold Immersion on Patients With Varicose Vein

In the literature, it is stated that cold water immersion to lower extremities is effective on the symptoms of the disease. Studies have shown that cold water immersion, which is one of the cold application methods, has effects on increasing joint mobility, reducing pain, reducing stress, anxiety, depression, and increasing quality of life etc.

For this reason, the study is planned as a randomized controlled interventional study to determine the effect of cold water immersion directly to the lower extremity in the preoperative period of patients with varicose veins on quality of life, anxiety and symptoms experienced.

The experimental group will be informed about the lower extremity cold immersion bath during the outpatient clinic controls and will be given a liquid meter digital thermometer that will allow them to check the cold water temperature at home. Patients will then be asked to do the lower extremity cold water immersion bath every day in their own home, for a total of four weeks, lasting 20 minutes in the evening before going to sleep.

It is recommended that the cold water immersion for 20 minutes and the temperature of the water should be 15 0C for it to be effective on the symptoms.

At the end of four weeks, patients will be informed that they should come to the outpatient clinic again. When the patients come to the outpatient clinic, information about the application will be repeated and data collection forms will be applied by face-to-face interview method.

To the patients in the control group; during the research process, routine outpatient controls will be made and no attempt will be made during the research.

Eligibility Criteria:
Inclusion Criteria:

* Those between the ages of 18-65
* Those who have been diagnosed with lower extremity varicose disease for at least 1 year
* Those who have not had previous surgery due to varicose veins
* No visual, hearing and sensory impairment/neurosensor disorder problem
* No mental status disorder
* With intact skin integrity and no open wounds
* No circulatory disorder

Exclusion Criteria:

* The patient has a known cold allergy or hypersensitivity to cold
* Patient having surgery during the study
* The patient's desire to withdraw from the study
Evaluation of the Dental Vibe Injection Comfort System

This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation. The study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Objective: Pain from local anesthesia injections can be reduced by distraction and counter-stimulation techniques. This study investigated the Dental Vibe Injection Comfort System (DV), developed to lessen anesthesia pain through pulsed vibration, a form of counter-stimulation.

Design: Our study's aims were to evaluate DV's efficacy in reducing pain/discomfort from intra-oral long buccal (LB) and inferior alveolar nerve (IAN) injections and the time needed to achieve complete anesthesia during an IAN block.

Methods: The sixty subjects, equally split by sex, ages 21-32, rated injection pain on a visual analog scale and discomfort, unpleasantness, and difficulty in enduring the injection on a modified symptom severity index. Each subject received bilateral LB injections and an IAN block. Using block design, DV Generation 3 (DV3) was randomly assigned to either the first or second LB injection and to thirty subjects on their third injection, the IAN block. No topical anesthesia was applied.

Eligibility Criteria:
Inclusion Criteria: Able to volunteer for dental anesthesia -

Exclusion Criteria: Non volunteer

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Prospective Multi-Center Trial for FemBloc Permanent Birth Control

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.

Eligibility Criteria:
Inclusion Criteria:

* Female, 21 - 50 years of age desiring permanent birth control.
* Sexually active with male partner.
* Regular menstrual cycle for last 3 months or on hormonal contraceptives.

Exclusion Criteria:

* Uncertainty about the desire to end fertility.
* Known or suspected pregnancy.
* Prior tubal surgery, including sterilization attempt.
* Presence, suspicion, or previous history of gynecologic malignancy.
* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.
* Abnormal uterine bleeding requiring evaluation or treatment.
PREPARE-M 2024 Undergoing Major Surgery: a Pilot Interventional

Study plan to conduct a pilot interventional study to evaluate the impact of a prehabilitation program on physical function and clinical outcomes. The prehabilitation program will include preoperative physiotherapy assessment, nutrition education, exercise instructions, and inspiratory muscle training for patients with MIP\<100 cmH2O. Currently, Singapore General Hospital offers the "Prehabilitation for Elderly Frail Patients Undergoing Elective Surgeries (PREPARE)" program, targeting frail patients undergoing major surgery. The primary outcome of the study is the change in physical function, measured by handgrip strength (HGS), from baseline to 3 days before surgery. Secondary outcomes include changes in the 6-minute walk test (6MWT), maximal inspiratory pressure (MIP), and sit-to-stand (STS) parameters from baseline to 3 days before surgery and 4-5 weeks postoperatively. Additionally, study will also assess postoperative complications (using the Comprehensive Complication Index), postoperative morbidity (using the Postoperative Morbidity Survey), length of hospital stay (LOS), and Health-Related Quality of Life (HRQoL) outcomes.

The exercise instructions given in the PREPARE program are part of the standard treatment and care is taken to ensure that the exercises are done safely at home. The only research segment is measurement of the parameters and clinical outcomes."

Patient Visits: 1. Recruitment/Enrollment (Visit 1 - coincide with PAC visit) Once informed consent is obtained. Patients will have the following measurements taken.

1. Baseline Maximal Inspiratory Pressure (MIP) using a handheld digital manometer,
2. 6-minute walk test (6MWT),
3. handgrip strength (HGS) of the dominant hand, and
4. 30s and 1-minute Sit-To-Stand (STS).

In addition, all patients will receive the routine (20 - 40 minutes) preoperative physiotherapy education, home exercise instructions and inspiratory muscle training (if MIP \< 100 cmH2O).

2. Follow up (Phone call) Patients will receive follow-up phone calls once weekly to check if they have any problems following the home exercise instructions given to them on visit 1.

3. Follow up (Visit 2) - Pre-Op (3 days before Operation) Patients will have the measurements taken again.

4. Follow up (Visit 3) - Between 4 to 5 weeks post-operation. Patients will have the measurements taken again.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 65 years who are undergoing elective major non-cardiac surgery
* Edmonton Frail Score (EFS) of 6 or higher

Exclusion Criteria:

* Patients who are unable to provide written informed consent
Progesterone Primed Endometrial Protocol Versus Gonadotropin-releasing Hormone Antagonist Protocol in Assisted Reproductive Treatments

The aim of this study was to compare the clinical outcomes in progesterone primed endometrial protocol versus gonadotropin-releasing hormone antagonist protocol in women undergoing assisted reproductive treatments.

Utilizing the assisted reproductive techniques (ART) has exhibited a substantial rise within the last years, emerging as a crucial modern medicine component with reliable results.

The utilized protocols for endometrial preparation in ART are aimed at maximizing the treatments' success. Typically, utilizing gonadotropin-stimulating hormone (GnRH) antagonists or agonists remains involved for preventing an early luteinizing hormone (LH) peak along ovulation prior to oocytes retrieval.

The GnRH-antagonist (GnRH-a) protocol is favored by many clinicians as well as patients due to its simplicity, convenience, flexibility, and absence of functional ovarian cysts or "menopausal" symptoms linked to the agonist protocol. Nevertheless, some RCTs' findings address that the antagonist protocol yields a reduced oocytes' number. Additionally, it exhibits lower pregnancy rates as opposed to the agonist extended therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 to 40 years.
* A basal antral follicle count (AFC) \<6.
* All patients had to have a body mass index between 18.5 to 29.9 kg/m2.
* Undergoing IVF/ICSI cycles.
* With previous poor response to conventional prolonged therapy utilizing GnRH agonists (retrieving three oocytes).

Exclusion Criteria:

* Cycles with fresh embryo transfer.
* Transfers of cleavage embryos (d2/d3).
* Embryos from cycles with preimplantation genetic screening.
* Cryopreservation of oocytes.
* Oocyte donation cycles.
* Cycles that produced embryos but without et at the time of the analysis.
Children and Adolescent Registry for Diabetes Study in Jiangxi

This study aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Background:With the development of economy and the improvement of people's living standards, the incidence of childhood diabetes is rapidly increasing.The multicenter, prospective,retrospectively in children and adolescents registry for diabetes in jiangxi aims to understand and evaluate different age children and adolescents with diabetes prevalence, self-management of disease , for diabetes patients and their families to provide diabetes management information, so as to help the children and adolescents diabetes patients to improve the quality of life.

Methods:The province's multi-center, prospective、retrospective study, the number of cases planned to be included in 300 cases.The inclusion criteria:A diagnosis of diabetes;reported for diabetes by parents and patients or by doctors and medical records to prove all of the patients;0-30 years old, gender not limited;voluntary participation and sign a consent form.Exclusion criteria

:At the same time, other test drugs or are other clinical trials;Due to other reasons, the researchers think that the person doesn't fit into the group;Diabetes during pregnancy;Besides diabetes diagnosis of tumor, cardiovascular disease and other interfere with the results of the study of disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1 days to 30 years who were diagnosed with diabetes according to the World Health Organization criteria;
* Gender is not limited.

Exclusion Criteria:

* Gestational diabetes mellitus;
* Patients with malignant tumor,cardiovascular disease and other interference with the results of the study of the disease.
* Patients are participating in any other clinical studies;
Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients

The goal of this study is to compare the effects of Potassium Magnesium Citrate to Potassium Chloride on blood pressure among patients with pre-hypertension or mild hypertension. We will also test whether Potassium Magnesium Citrate increases excretion of large amounts of sodium in the urine.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 21 years
* BMI \> 18.5 kg/m2 and \< 40 kg/m2
* Prehypertension and mild hypertension: BP systolic 120-159 mmHg, diastolic 80-95 mmHg
* Must agree to limit lifestyle changes including: 1) embarking on a new exercise or weight reduction program 2) altering alcohol intake during the trial.

Exclusion Criteria:

* Taking blood pressure lowering medication
* Diabetes mellitus
* Renal disease
* Active cardiac disease
* Active liver disease
* Chronic diarrhea
* Chronic NSAID use
* Active or suspected drug use
* Uncontrolled psychiatric disease
* HIV infection
* Missed more than 20% of clinic visits in the last yr
* Prescription of diuretics for any reason
* A patient taking nutritional supplements including multivitamins that is unwilling to discontinue them,\\
* Consumption of greater than 14 alcoholic beverages per week
Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

To determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the NICU is the aim of the study. The study will be two groups randomized clinical trial of five days intervention program. The intervention will be given among two groups. Group A will receive both multisensory stimulation and soft tissue therapy, Group B will receive only regular hospital care. The PIPP and N-PASS will be used for assessing pain. The INFANIB and Premie-Neuro will be used for assessing neuromotor development among neonates. The outcomes will be taken before and after the fifth day of the intervention. Multisensory stimulation and soft tissue therapy might help in reducing pain and promoting neurodevelopment.

This study will utilize two parallel groups, randomised design to analyze the effects of soft tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates admitted in NICU will be recruited through purposive sampling for the trial. Procedural pain will be assessed with PIPP and N-PASS through recorded video. Neurodevelopmental outcomes will be assessed with INFANIB Scale and Premie-Neuro. The measurements will be taken after 24 hours of birth at the baseline and after the fifth day of the intervention. The treatment will be given into two groups i.e. Group A (Multisensory stimulation and soft tissue therapy group), Group B (routine hospital care). MSS will consist of Auditory Stimulation, Tacto-Kinesthetic stimulation, Vestibular stimulation, Visual stimulation, Oral-stimulation, and Olfactive stimulation. Soft tissue therapy consisted of stroking, effleurage, skin rolling, and kneading techniques, Will be given in 5 Phases-Forehead and face, Back and Neck, Chest and abdomen, upper-lower limbs. Total 30 min. of the treatment plan, per day, will be given to the neonates, after 30 min. of feed, for up to 5 days of NICU stay.

Eligibility Criteria:
Inclusion Criteria

* Preterm between 30- 36 weeks of gestation
* Birth weight \>1000 g
* Not receiving analgesics/sedatives
* APGAR score ranged between 4-6 in 1 min. \& 7 to 9 in 5 min.
* Undergoing routine healthcare procedures in NICU

Exclusion Criteria

* Preterm with surgery
* Preterm having unstable vitals
* Preterm with congenital malformations
* Preterm who require mechanical ventilation
* Having inborn errors of metabolism and also with seizures disorders,
Evaluation of Endogenous Pain Modulation Mechanisms With Transcutaneous Electrical Nerve Stimulation

A number of chronic pain conditions are characterized by imbalances in excitatory and/or inhibitory mechanisms and these deficits appear correlated with the response to certain treatments. Evaluating these mechanisms among people who suffer from chronic pain could allow clinicians to adapt the treatment to each patient according to the deficits observed. To evaluate excitatory and inhibitory mechanisms, a thermode (hot plate) and a cold water bath can be used (standardized protocol). Unfortunately, these tools are expensive, time-consuming and require complex equipment and software. As such, it is not realistic for clinicians to use them for routine patient assessment. A potential alternative to study these mechanisms is TENS (transcutaneous electrical nerve stimulation). TENS is frequently used in rehabilitation and unlike thermode and cold water bath, is affordable, easy to use and requires very little time and equipment. The objective of this study are to determine if the TENS can replace the thermode and cold water bath (standardized protocol) for the evaluation of excitatory and inhibitory mechanisms. Also, to determine if there will be a correlation with the standardized protocol. 50 healthy participants between 18 and 60 years old will participate in this study. Each participant will attend two experimental sessions. In one of the two sessions, the evaluation will be done with the TENS; in the other session, the evaluation will be done with the standardized protocol (thermode and cold water bath).

To evaluate excitatory and inhibitory mechanisms, the investigators will used the modified CPM testing procedure consisting of test stimulus (TS) administered before and after a conditioning stimulus (CS). For the standardized protocol, the TS will consisted of a noxius heat stimulus generated by a thermode (hot plate), applied for two minutes on the non-dominant anterior forearm. The CS will consisted of a cold pressor test (CT), wherein participants immersed their dominant forearm in a cold water bath for two minutes. For the TENS protocol, the TS will consisted of a noxius electrical stimulus generated by TENS, applied for 5 seconds on the non-dominant knee at a frequency of 1 Hz and 5 Hz. The CS will consisted of a noxius electrical stimulus generated by TENS' applied for 120 seconds on the non dominant knee and ankle at a frequency of 2 Hz.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman between 18 and 60 years old (inclusive)

Exclusion Criteria:

* Chronic pain
* Neurological disorders
* Musculoskeletal disorders
* Depression
* Raynaud syndrome
* History of non-efficacy with TENS
* History of epilepsy
* Presence of a pacemaker or metal implants
* Antidepressant
* Anticonvulsant
* Analgesics
* Caffeine
Drug Related Problems Among Patients With Femoral Neck Fractures in an Orthopedic Ward

the purpose of the study is to:

1. Identify and characterize drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at "Meir" medical center.
2. Evaluate the contribution of a clinical pharmacist in identifying,characterizing and preventing drug related problems in patients after a femur neck fracture that are hospitalized in the orthopedic department at "Meir" medical center.


Eligibility Criteria:
Inclusion Criteria:

* patients over 64
* patients after a femoral neck fracture
* patients hospitalized in the orthopedic ward at "Meir" medical center
* patients who speak Hebrew, Russian or English

Exclusion Criteria:

* patients under 64
* patients without a femoral neck fracture
* patients who don't speak Hebrew, Russian or English
The Impact of Blood Flow Restriction (BFR) on Exercise and Hemodynamic Responses

The impact of blood flow restriction (BFR) on exercise and hemodynamic responses will be studied. The use of BFR will be studied during yoga and low-intensity aerobic exercise in healthy subjects with no history of chronic illness ranging from 18-40 years of age. This study will evaluate several conditions related to cardiovascular physiology in order to determine the safety and efficacy of this type of exercise training. First, the effects of two distinct types of BFR cuffs (BStrong and Hokanson) will be studied during low-intensity aerobic exercise on vascular function. Second, the effect of yoga will be studied with and without the use of BStrong bands on vascular function. Outcome measures include acute effects on endothelial function i.e. flow-mediated dilation, arterial stiffness, beat-by-beat blood pressure, heart rate, RPE (rate of perceived exertion), and blood lactate. For this intervention, the BFR cuffs will be used during exercise to evaluate its safety and efficacy. Since BFR is becoming a widely popular method of exercise, it is important to study its safety and hemodynamic effects.

Participants will be tested a total of 5 times; twice for the yoga portion and thrice for the aerobic exercise (walking) portion. Outcome measures will be consistent across the five visits and will take approximately 2.5 hours to complete. The order of the five separate sessions will be randomized such that the participant cannot expect which condition they will be performing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Pregnancy
* A recent illness, recent surgery, or any medical intervention
* history of diabetes, heart disease, or other cardiovascular problems