cyrilzakka/clinical-trials huggingface dataset:
Protein Supplementation and Exercise Training in Burn Patients

Burn injury causes continuous catabolism of the skeletal muscle resulting in decreased muscle strength, muscle mass and impairment of functional mobility. Purpose: The purpose of this study is to investigate the efficacy of combination of exercise training and protein supplementation on lean body mass (LBM) and muscle strength in patients with severe burn.

Sixty participants with severe burn \> 30% total body surface area (TBSA) were randomly distributed into 4 equal groups of 15 participants per group. Group A (Protein+ Exercise group) received oral protein supplementation, exercise program and traditional burn care, group B (Protein group) received oral protein supplementation and traditional burn care, group C (Exercise group) received exercise program and traditional burn care, group D (Control group) received traditional burn care. LBM was measured using Dual-energy x-ray absorptiometry (DXA) while muscle strength was measured using Biodex 3 Dynamometer System before treatment and 12 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* healed deep partial-thickness thermal burn
* \> 30% of TBSA and
* the exercise program started after healing of the burn (after burn injury by 6 weeks)

Exclusion Criteria:

* conditions that may affect on participation in the exercise program as a recent coronary disease, uncontrolled hypertension, orthopedic problems limiting exercise, abnormal cardiac stress test, pregnant women, refusal to participate in a physical activity program,
* presence of psychological or cognitive disorders (aggressive behavior, impulsivity, dementia)
* food intolerance to milk protein products.
A Survey of Midazolam in People With Status Epilepticus

This study is a survey in Japan of midazolam oromucosal solution used to treat people with status epilepticus. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from midazolam oromucosal solution and to check if midazolam oromucosal solution improves symptoms of status epilepticus. During the study, participants with status epilepticus will take midazolam oromucosal solution according to their clinic's standard practice. The study doctors will check for side effects from midazolam for 6 months.


Eligibility Criteria:
Inclusion Criteria

* Participants with non-convulsive status epilepticus
* Participants treated with study drug outside the medical institution
* Participants receiving an additional dose of study drug

Exclusion Criteria Participants have any contraindication to midazolam.
Study Assessing the Effects on Endometrium and Breast of Isoflavone in Post Menopausal Women

The main objective of this study is to determine the effects on the endometrium and breast of 70 mg daily dose of isoflavones.

This is an international multicentre open study, assessing the innocuity on breast and endometrium of a 70 mg daily dose of isoflavones standardized extract (Phytosoya).

This study follows the European guidelines :one-year treatment duration, biopsy and mammography performed at the beginning and at the end of the trial, recruitment of enough subjects in order to have 300 patients with an evaluable biopsy after one year of treatment.

After 3 weeks of screening phase, the patients will be taken Phytosoya during 52 weeks. At the end of the first year of treatment, an endometrial biopsy, an endovaginal ultrasonography, a mammography, breast ultrasounds, a clinical examination and a biological assessment will be performed.

In addition, it will be proposed to patients to continue treatment during 2 additional years. At the end of the third year,the same examinations will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Not hysterectomised women
* Post menopausal (at least 2 years)
* FSH superior to 30 UI/l and oestradiol inferior to 35 ng/ml
* Presenting with hot flushes (but not incapacitating) or climacteric symptoms

Exclusion Criteria:

* History of endometrial hyperplasia
* Known hormono-dependent malignant tumours
* BMI superior to 30 Kg/m2
* Uncontrolled arterial hypertension
* Known renal or liver insufficiency
* Recent or evolutive thromboembolic disease
* Unexplained bleeding, endometrial polyps, submucous myomas, active endometriosis, ovarian cyst superior to 30 mm
* Local hormonal treatment, raloxifene,tibolone within the 3 months before V1 and during the study
* HRT and DHEA within the 3 months before V2 and during the study
* isoflavones within the 2 months before V2 and during the study
* clonidine, beta-alanine, veralipride within 1 month before V1 and during the study.
Clinical Trial Assessing 5-HT3 Receptor Antagonist (Ramosetron) for the Treatment of Anterior Resection Syndrome

Poor functional outcomes has been reported inevitably, and up to 90% of the patients have experienced bowel habit changes after sphincter-saving surgery for rectal cancer. But, currently there has been no specific treatment for ARS and symptom based empirical management is tried Recently, 5-HT3 receptor antagonists can be used for treatment of IBS-D, and has been revealed to be slowing the bowel movement and improving stool consistency and urgency.

We performed the clinical trial with using ramosetron (Irribow®) for the treatment of ARS


Eligibility Criteria:
Inclusion Criteria:

* The patients who undergo sphincter saving surgery for rectal cancer

Exclusion Criteria:

* recurred rectal cancer
* rectal cancer with distant metastasis
* permanent stoma formation
* postoperative concurrent chemoradiotherapy
* uncontrolled medical disease
* inflammatory bowel disease
* uncontrolled constipation
* preoperative incontinence (LARS score, more than 20)
* allergic to intervention drug
Connected Scales to Optimize the Maintenance of Weight Lost After Bariatric Surgery and Limit Failures and Reoperations

In this research, we hypothesize that post-operative monitoring implemented with a connected scale after the 1st year (weight nadir period) post obesity surgery (i.e. sleeve and RYGB) would reduce the percentage of patients with excessive weight regain (\>10% regain of lost weight) by improving the quality of follow-up and long-term results.

To do this, we are carrying out a comparative study on 182 patients, controlled, randomized per patient, ratio 1/1, open, in two parallel arms.

Patients will be followed for 12 months and divided into one of the following two groups:

* Control group: Standard follow-up
* Interventional group: Standard follow-up + weekly weighing with the "Body Comp Pro" connected scale

During their follow-up period, patients in the intervention group will have to weigh themselves at least once a week using the "Body Comp Pro" connected scale. The information will be transmitted to the investigation team via a secure platform available 24 hours a day. Alerts will be generated from a weight regain \> 5% of the baseline weight, allowing early management of weight regain.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient aged 18 and over
* Patient operated by a sleeve or RYGB at 1 year (+/- 1 month) from the inclusion visit
* Patient affiliated to a social security system (excluding AME)
* Patient having signed free, informed and written consent
* Patient speaking and reading French fluently

Exclusion Criteria:

* Patient with medical-surgical complications during inclusion visit justifying specific and reinforced monitoring (at the discretion of the investigator)
* Patient with a pacemaker
* Patient with a pathology or disability preventing them from standing on the scale
* Patient participating in another interventional research at the time of inclusion
* At the interview, pregnant patient or planning pregnancy during her period of participation in the research
* Patient deprived of liberty
* Patient subject to a legal protection measure (guardianship, curatorship)
Effect of Cultural Marginality Theory-Based Education on Intercultural Adaptation and Psychological Well-Being of Foreign Nursing Students

In this study, between 1 - 31 December 2022, who met the inclusion and exclusion criteria, a total of 66 foreign nursing students who are with 1st year foreign students starting the Nursing Department of Ondokuz Mayıs University and Mersin University.

The Cultural Marginality Theory-Based Education program will be held in a face-to-face classroom environment for the students in the experimental group. This training program has been developed based on the concepts of Cultural Marginality Theory. The content and topics of the sessions in the program are arranged according to the conceptual structure and flow of the theory. The training program was created in a certain flow, based on the concepts of recognizing intercultural conflict (2 sessions), marginal living (2 sessions) and alleviating cultural tension (2 sessions). There are 6 sessions in the program and the frequency of sessions is 2 times a week, and each session lasts approximately 45 minutes. The training program will be applied to 33 foreign nursing students in the experimental group. In the first session to the students in the experimental group and to the students in the control group after the post-tests, the training booklet, which consists of information about the educational content in the program, will be given online in pdf format in color and with pictures.

Eligibility Criteria:
Inclusion Criteria:

1. being a first-year foreign nursing student studying at state universities in the north and south two cities of Türkiye,
2. agreeing to participate in the research
3. not having communication barrier

Exclusion Criteria:

1) having a physical or mental illness that would prevent participation in the research

The Termination Criteria:

1. withdrawing from the research voluntarily
2. not attending at least one of the sessions
3. incomplete or incorrectly answering the instruments
A Registry Study of Shujinjianyao Pill Used in Clinical Real World

The purpose of this study is to get to know how Shujinjianyao Pill in hospital results in drug-induced liver injury or other adverse drug reactions from a cohort event monitoring as registration research.

In order to monitor drug-induced liver injury or other adverse drug reactions of Shujinjianyao Pill in clinical real world, registry study is a suitable method in this area. Meanwhile, the investigators will use nested case-control study to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or other adverse drug reactions is one of the main aims for this study. Therefore, Safety monitoring of Shujinjianyao Pill is an very important problem that needs to be done through a large sample observational study. According to the relevant regulations of the state drug administration(SDA), 3000 cases need to be registered at least. The aim population is who use Shujinjianyao Pill with normal liver function before medication from June 2018 to October 2019.

Eligibility Criteria:
Inclusion Criteria:

* 1.Patients with normal liver function before medication.
* 2.Patients suffered from Waist and knee pain or sciatica.

Exclusion Criteria:

* 1.Patients who are pregnant, phrenetic, and suffered from serious illness.
* 2.Patients suffered from viral hepatitis or autoimmune hepatitis or alcoholic hepatitis or hereditary metabolic hepatitis or cirrhosis or cancer of the liver.
Self-Control in Bulimia Nervosa

This study examines the influence of acute fasting and eating on self-control in adult females with and without bulimia nervosa (BN). Specifically, the study team is investigating whether differences in behavior and brain activation in response to computer tasks after fasting and after eating a meal could help to explain the symptoms of bulimia nervosa. Data will be collected using questionnaires and a technology called magnetic resonance imaging (MRI).

Treatment-resistant binge eating and purging may be perpetuated by self-control deficits linked to reduced activation in frontostriatal circuits. To date, however, neurocognitive studies of BN have not assessed the dynamic computational processes underlying inhibition or considered the fact that individuals with BN oscillate between two extremes-under-controlled and over-controlled intake. The proposed study combines neuroimaging with computational modeling to investigate the influences of acute fasting and eating (i.e., metabolic states) on how the brains of women with bulimia nervosa (BN) adaptively prepare for and exert inhibitory control. More specifically, the study has the following main objectives: 1) To determine whether eating and fasting affect adaptive inhibitory control and related frontostriatal activation abnormally in BN; 2) To identify associations of BN severity with state-specific frontostriatal activation and behavior.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 35 years
* Currently between 85 and 130% of the expected weight for height
* Right-handed
* English-speaking

Additional Inclusion Criteria for Women with Bulimia Nervosa:

° Meet DSM-5 criteria for bulimia nervosa

Exclusion Criteria:

* Medical instability
* Ongoing medical treatment, medical condition, or psychiatric disorder that may interfere with study variables or participation
* Shift work
* Pregnancy, planned pregnancy, or lactation during the study period
* Allergy to any of the ingredients in or unwillingness to consume the standardized meal or unwillingness to drink water during the fasting period
* Any contraindication for fMRI
Islet Function and Clinical Analyses of Transplant Recipients

To follow the patterns and natural history of Islet Transplant recipients (the ones that were involved in the Modified Edmonton Protocol) using oral glucose to check sugar levels as well as insulin and C-peptide over the course of 5 years


Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes with hypoglycemia unawareness that received a Islet Transplant here at Washington University
* "control" subjects were matched to the transplant recipients base upon age, height, weight, \& race (and could not have diabetes)

Exclusion Criteria:

* well controlled Type 1 diabetes
* transplant failure
* unable to match potential subject to a recipient
Diagnosis and Response to Treatment Using a Reliable Gastroesophageal Reflux Disease (GERD) Questionnaire: An In Clinical Practice Study

The purpose of the study is to determine the applicability and utility of Gerd Q in the diagnosis of GERD and in the assessment of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either gender aged between 18-79 years of age
* Patients must be having symptoms of gastroesophageal reflux disease

Exclusion Criteria:

* None
Auditory Sensory Attenuation in Obesity

The goal of this observational cross-sectional study is to test the sensory attenuation effect with auditory stimuli comparing women with obesity and healthy-weight women. Specifically, the study aims to test whether the sensory attenuation effect (i.e., the perceived loudness of a self-generated sound is weaker than when another person produces the same sound):

i) is observed in obesity ii) it can be modulated in interactive action contexts, as was previously observed in healthy participants.

Participants will compare the loudness of target sound with a comparison tone, which can be prompt by the participant by pressing a button on their own will (i.e., individual context) or upon the experimenter\&#39;s signal (i.e., interactive context); externally-generated sounds are produced in the opposite way.

The perceived loudness of a self-generated sound is generally weaker than when another person produces the same sound. This effect is known as sensory attenuation, and it is considered a proof of sense of agency (i.e., it relies on the anticipation of the sensory-motor effects of one\&#39;s intentional action). Recently, it was suggested that this effect is enhanced in interactive action contexts in healthy individuals, meaning that sounds are produced as a consequence of cooperation between individuals.

Participants will compare the loudness of target sound with a comparison tone, which could be generated in 4 different conditions:

i) participants press a button ii) the experimenter press the button iii) participants press the button upon the experimenter\&#39;s signal (i.e., who touch the participants\&#39; arm) iv) the experimenter presses the button upon the participants\&#39; signal (i.e., who touch the experimenter\&#39;s arm).

However, it is not clear whether the same effect of cooperation can be observed also when individuals experience difficulties in social interactions and relationships.

To this purpose, the study compared the sensory attenuation effect for auditory stimuli in a traditional (i.e., individual) and interactive context, comparing women with obesity and healthy-weight women.

Indeed, relational difficulties and social withdrawal characterized this clinical condition.

Eligibility Criteria:
Inclusion Criteria:

* BMI \&gt; 30 kg/m2 (controls)
* handedness: right

Exclusion Criteria:

* history of eating disorders (controls)
* major psychiatric conditions (e.g., psychosis, personality disorders)
* developmental disorders (e.g., autism spectrum disorders)
* neurological or brain injuries disorders
* motor impairments
BG9924 in Combination With Methotrexate for Participants With Active Rheumatoid Arthritis

This Phase 2b study is designed to evaluate the efficacy and safety of BG9924 given subcutaneously (SC) versus placebo in participants with active rheumatoid arthritis (RA) who have previously had an inadequate response to treatment with anti-tumor necrosis factor (anti-TNF) therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of rheumatoid arthritis (functional class I - III) at least 6 months prior to baseline
* Methotrexate (10 mg/week to 25 mg/week) \> 3 months prior to Day 0 (stable dose \> 4 weeks prior to Day 0)
* Must have had an inadequate response to anti-TNF therapy due to inadequate efficacy

Key Exclusion Criteria:

Medical History

* Serious local infection or systemic infection within 3 months of Day 0
* History (Hx) of recurrent infections requiring oral or parental anti-infective treatment
* Hx of tuberculosis (TB) or positive purified protein derivative (PPD) test during the screening period

Laboratory Tests

* Clinically significant lab tests at screening; or
* Positive for hepatitis C antibody or hepatitis B at screening

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Modified Hip Capsular Incision: an Easier Way to do Hip Capsulorrhaphy in Developmental Dysplasia of the Hip (DDH)

Developmental dysplasia of the hip (DDH) is the commonest hip problem seen by pediatric orthopaedic surgeons (1). DDH refers to an abnormal configuration of, or relationship between, the femoral head and the acetabulum .Principals of surgical treatment of DDH, however, always include reduction and stabilization. These principals could be applied by conservative or surgical means (2). Goal of Treatment options to Obtain and maintain reduction without damaging femoral head. Surgical Stabilization might be required in cases with failed conservative treatment, residual dysplasia or older children with neglected DDH. Surgical stabilization is generally achieved by a reduction into a near anatomical position and a complementary capsulorrhaphy (3). In the classic T-shaped capsular incision, the vertical branch parallel to the axis of the neck and the horizontal branch 5 mm from the iliac insertion of the capsule, from anterior and downward to posterior and upward. Two flaps are thus obtained (4). It was noticed that doing capsulorrhaphy after head reduction is cumbersome with this technique because it needs shallow-curved needles while suturing in narrow field and sometimes the suture material gets avulsed from medial flab. A suggested technique by doing a modified incision to make re -suturing of the capsule easier with multiple stitches.

This Modified incision to make re -suturing of the capsule easier with multiple stitches.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-7 years old
* Primary DDH

Exclusion Criteria:

* Paralytic hip DX in cases of (Cerebral palsy,Meningomyelocele,Neuropathy or Myopathy)
* Recurrent cases of DDH
A Study of the Safety and Effectiveness of DDP733 in Treating IBS With Constipation in Females

This study will evaluate the safety and effectiveness of the investigational drug DDP733 in treating female patients with IBS-c. A placebo control will be utilized.


Eligibility Criteria:
Inclusion Criteria:

* Female from 18 to 65 years of age, inclusive
* Patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. The patient's symptoms must be associated with 1 or more of the following:

  * Improvement with defecation
  * Onset associated with a change in frequency of stool
  * Onset associated with a change in form (appearance) of stool
* Negative serum and urine pregnancy tests
* Completion of at least six days of daily diary assessments using a phone-in information system prior to randomization

Exclusion Criteria:

* Serious underlying diseases, including psychiatric disorders
* Current history of conditions affecting bowel transit
* Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection
* Clinically significant abnormal examination findings or laboratory tests
* Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments
* Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome
* Presence of a medical condition which could interfere with the interpretation of study data
* Significant use of nicotine or caffeine
Percutaneous vs Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain

This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.

Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.

Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.

Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old.
* Both sexes.
* Patients with knee osteoarthritis.
* Previous conservative treatments longer than 3 months.
* Visual analog scale (VAS)≥ 4.
* Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).

Exclusion Criteria:

* Prior knee surgery.
* Allergies to local anesthetics.
* Connective tissue diseases affect the knee.
* Serious neurologic or psychiatric disorders.
* Injection with steroids or hyaluronic acids during the previous 3 months.
* History of septic arthritis.
* Sciatic pain.
* Cardiac pacemaker users.
* Anticoagulant medications.
* Prior electroacupuncture treatment.