cyrilzakka/clinical-trials huggingface dataset:
Dapsone Prurigo Study

Principal aim of this study is to assess whether a combination of topical dapsone and clobetasol as a topical steroid is superior to clobetasol alone as treatment of prurigo nodularis or lichen simplex chronicus in a side to side comparison. The study is primarily exploratory and essentially meant to inform the sponsor whether further development of a combination treatment formulation is warranted


Eligibility Criteria:
Inclusion Criteria:

* • Active prurigo nodularis or lichen simplex chronicus - diagnosed by clinical exam

  * For lichen simplex chronicus patients: Severity of maximum pruritus in the last 24 hrs at least 5 out of 10 on a visual analogue scale.
  * For prurigo nodularis patients: Excoriations or signs of other scratch related activity at presentation to demonstrate active disease
  * Symmetrical disease/excoriations allowing for a side-by-side comparison (eg, bilateral lichen simplex chronicus or bilateral prurigo nodularis) - genitals, face, axillae or neck cannot be used for side-to-side comparison
  * Willing to refrain from use of all other topical medications in the treatment areas.
  * Able and willing to provide written informed consent
  * Willing and able to understand and comply with the requirements of the study, apply the treatment combinations as instructs, attend required study visits, comply with study prohibitions and able to complete the study.
  * Male or non-preganant, non-lactating female between 18 and 75 years of age, inclusive
  * For females of child-bearing potential, willing to use adequate birth control during the study conduct

Exclusion Criteria:

* • History of non-compliance with follow up visits

  * Should we exclude failure to certain treatments as an exclusion criterion? Patients who failed oral dapsone should be excluded
  * Presence of any skin condition on the treatment areas that would interfere with the diagnosis or assessment of active lichen simplex chronicus and/or prurigo nodularis (eg, rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis or bacterial folliculitis)
  * Excessive hair in the treatment area that would interfere with diagnosis or assessment of lichen simplex chronicus and/or prurigo nodularis
  * History of hypersensitivity or allergy to topical steroids, dapsone, or any other treatment product components
  * Use of tanning booths, sunbathing or excessive exposure to the sun during the study
  * Consumes excessive amount of alcohol, abuses drugs, or has any condition that would compromise compliance with this protocol
Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects

Exclusion Criteria:

* Evidence or history of clinically significant findings at screening
Biotin Status in Pregnancy

The purpose of this study is to estimate the number of pregnant women who, during pregnancy, have low levels of the vitamin biotin. The hypothesis of this study is that a large number of pregnant women will have low biotin levels. This information will be used to later determine if low biotin levels during pregnancy cause certain birth defects.


Eligibility Criteria:
Inclusion Criteria:

* age 18-40
* in early pregnancy (less than 15 weeks gestation)
* under care of physician
* normal pregnancy
* taking prenatal vitamin with less than 30 mcg biotin

Exclusion Criteria:

* prenatal vitamin with greater than 30 mcg biotin
* antibiotic use
* known renal disease
* drug, alcohol abuse
* gastric bypass
* daily diet high in biotin
* use of certain meal replacement products high in biotin
* previous history of children with birth defects
ROSSETTI: Registry of Combined vs Single Thrombectomy Techniques

The ROSSETTI registry is an ongoing investigator-initiated prospective study recruiting deidentified demographic, clinical presentation, site-adjudicated angiographic, procedural, and outcome data in acute ischemic stroke (AIS) consecutive patients treated with mechanical thrombectomy (MT) across 10 Comprehensive Stroke Centers in Spain. The registry started in June 2019 and therefore incorporates the more recent device technology

The study inclusion criteria are the following: age ≥18 years; confirmed large vessel occlusion (LVO) in the anterior circulation (intracranial internal carotid artery M1, proximal M2 segments, time from last seen well to treatment (TLSWT) \<24 hours, baseline National Institutes of Health Stroke Scale (NIHSS) score ≥2, and premorbid modified Rankin Scale (mRS) score ≤2. All participating centers received institutional review board approval from their respective institutions and patients or representatives signed informed consent. The study data are collected prospectively through an online questionnaire. Type of stent-retriever , as long as European Community approved, is at the discretion of the operator.

The primary clinical outcome is the rate of excellent clinical outcome, defined as mRS score 0-1 at 90 days (no or minor symptoms but no functional limitations).\[28\] The primary technical outcome is the rate of first pass effect (FPE) defined as achieving near-complete/complete revascularization \[modified Thrombolysis in Cerebral Infarction (mTICI 2c-3)\] after single-device and single-pass approach

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years;
* confirmed large vessel occlusion in the anterior circulation (intracranial internal carotid artery, M1segment of middle cerebral artery, proximal M2 segment of middle cerebral artery
* time from last seen well to treatment (TLSWT) \<24 hours,
* baseline National Institutes of Health Stroke Scale (NIHSS) score ≥2,
* premorbid modified Rankin Scale (mRS) score ≤2.

Exclusion Criteria:

* No evidence vessel occlusion.
* Extra and Intracranial occlusion or severe stenosis.
* Low platelets (100 x 10000) or impaired function,
* Contraindication of computed tomography or magnetic resonance
* Allergy to iodinated contrast non treatable medically,
* pregnant or breast feeding patient,
* hemorrhagic stroke on computed tomography or Magnetic Resonance
Core Stability and Respiratory Parameters in Children With Thoracic Hyperkyphosis

Hyperkyphosis, defined as an excessive curvature of the thoracic spine beyond normal limits, is among the factors that reduce chest wall mobility and lung function. In modern society, increased sitting durations contribute to increased thoracic kyphosis. Studies have indicated that an increase in thoracic kyphosis and a decrease in thoracic spinal mobility are associated with reduced respiratory functions, such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).

The diaphragm forms the upper part of the core stability system. When contracted, it increases intra-abdominal pressure, contributing to core stability. The diaphragm also contracts in advance of and during limb movements to assist in postural control. Additionally, the diaphragm is the primary respiratory muscle responsible for inspiration. Any functional loss in the diaphragm, which alone accounts for 65-80% of vital capacity, can significantly reduce inspiratory capacity. During forced expiration, muscles such as the rectus abdominis, transversus abdominis, internal obliques, and external obliques play an active role. Specifically, the transversus abdominis, like the diaphragm, increases intra-abdominal pressure and supports trunk stabilization. However, the relationship between respiratory muscle strength and the endurance of core stability muscles remains unclear.

In light of this information, this study aims to investigate the relationship between the endurance of core muscles, which contribute to trunk stabilization, and respiratory parameters in children with thoracic hyperkyphosis.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 7 and 18
* Have a thoracic kyphosis angle (Cobb) of ≥45˚ on a lateral X-ray or a kyphosis index of ≤13

Exclusion Criteria:

* Individuals who have undergone major surgery or trauma related to the musculoskeletal system, particularly the spine and upper extremities
* Difficulty in understanding given instructions
* Presence of rigid deformity in the spine (Scheuermann's Kyphosis)
* Presence of congenital deformities (Congenital Kyphosis)
Parasitic Causes of Secretory Diarrhea in Children and Chronically Ill Adult.

Diarrhea is one of the most common reasons for people to seek medical advice - but it can range from being a mild, temporary condition, to be life threading condition. It is estimated that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million children below the age of 5 years, mostly in developing countries, die annually.

Secretory diarrhea has many causes as infection with bacteria, viruses or protozoa. It results from increased chloride secretion, decreased sodium absorption, or increased mucosal permeability . Parasitic pathogens induce Secretory diarrhea as they infect and damage the absorptive villus tips, leaving Secretory crypts unbalanced, to cause net secretion and diarrhea. Parasitic causes include Cryptosporidium parvum or hominis ,Capillaria philippinensis and Giardia lamblia. Cryptosporidiosis is also recognized as a cause of prolonged and persistent diarrhea in children and persons with impaired immunity. The disease is transmitted via the fecal-oral route from infected hosts. It can be also transmitted following animal contact, ingestion of water (mainly during swimming), or through food. Cryptosporidium has emerged as the most frequently recognized cause of water-associated outbreaks of gastroenteritis. This is because of the oocyst stage in its life cycle; Cryptosporidium can resist disinfection, including chlorination, and can survive for a prolonged period in the environment.

Eligibility Criteria:
Inclusion Criteria:

1. Children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of Assiut University pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period.
2. adult patients having acute watery diarrhea attend to out clinic labs of Assiut University hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period.

Exclusion Criteria:

1. viral and bacterial causes of diarrhea
2. Patients who were already diagnosed as intestinal inflammatory disease as irritable bowel syndrome.
3. Autoimmune conditions, such as ulcerative colitis, Crohn's disease and coeliac disease.
Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy

the aim of this study to assess different outcome measures after applying standard physical therapy plus radial shockwave and compare the results with another group who received standard treatment only.

Design: double-blinded (assessor and data analyzer)

Methods: This study will be conducted in 4 rehabilitation facilities, Times for 1 month of intervention Assessment timeline: 3 times (T0: at baseline, T1: at 4 weeks, T2: follow up at 3 months. Outcome measures: the Modified Ashworth scale (MAS), Ankle ROM, Plantar surface area, Gross motor function, and quality of life

the current study is a randomized controlled trial in which the researchers intended to examine the effect of adding radial shockwave therapy to standard physical therapy on the status of calf muscle spasticity and consequent effects on gross motor function, ankle joint ROM, plantar surface area, and quality of life.

the experimental intervention will consist of 4 sessions of radial shockwave applied to the bulkiest area of the calf muscle in children having spastic cerebral palsy. participants will receive 1 session of radial shockwave per week and will continue their regular physical therapy as usual (3 sessions per week).

outcome assessment will be conducted 3 times: at baseline, after the end of the treatment program, and at 3 months follow-up.

the tools that will be used to collect data will be:

1. Modified Ashworth scale for muscle tone.
2. Goniometer for Ankle ROM.
3. EMed force platform for plantar surface area
4. Gross motor function scale for gross motor function
5. Cerebral Palsy Quality of Life Questionnaire for quality of life assessment

Eligibility Criteria:
Inclusion Criteria:

* age between 8-14
* diagnosed with spastic CP
* ability to walk alone or with assistance
* grades 1 -4 on Gross Motor Function Classification System
* at least score 1 on the Modified Ashworth Scale (MAS)
* ability to attend the treatment program and the outcome assessment sessions.

Exclusion Criteria:

* patients who received a botulinum toxin injection in the calf muscle during the last six months
* structural contracture of the calf muscle
* surgery in the lower extremity during the previous year
* those experiencing pain in the lower limbs
* severe associated neurological diseases as epilepsy
* medications affecting peripheral muscle tone.
Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease

Comparison effectiveness two methods revascularization of the superficial femoral artery: remote endarterectomy vs. remote endarterectomy supplemented DCB angioplasty in patients with steno-occlusive lesion of the femoro-popliteal segment of TASCII D

Given that more and more devices appear to deliver cytotoxic drugs into the depth of atherosclerotic plaque, it is interesting to study the effect of these drugs when applied directly after plaque removal.

Eligibility Criteria:
Inclusion Criteria:

* Patients with occlusive lesions of C and D type femoral artery and with chronic lower limb ischemia (II-IV degree by Fontaine, 4-6 degree by Rutherford)
* Patients who consented to participate in this study.

Exclusion Criteria:

* Chronic heart failure of III-IV functional class by New York Heart Association (NYHA) classification.
* Decompensated chronic "pulmonary" heart
* Severe hepatic or renal failure (bilirubin\> 35 mmol / l, glomerular filtration rate \<60 mL / min);
* Polyvalent drug allergy
* Cancer in the terminal stage with a life expectancy less than 6 months;
* Acute ischemic
* Expressed aortic calcification tolerant to remote endarterectomy
* Patient refusal to participate or continue to participate in the study
Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants

A randomized, open-label study with antacid-control will be performed over 48 hours period by continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be separated into either groups according to alginate antacid group \[Gaviscon Advance (GA)®, Reckitt Benckiser, UK\] and non antacid alginate group \[simple antacid\]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid \[Gaviscon Advance (GA)®, Reckitt Benckiser, UK\] or non alginate antacid \[simple antacid\] which has equivalent strength of antacid after taking late night standardised meals.

Gastroesophageal reflux disease (GERD) with symptoms of heartburn and acid regurgitation is a common disorder especially in overweight and obese persons who are at increased risk for GERD. Late night supper, an usual eating habit in many parts of the world, may worsen GERD and especially so among the obese, and this may be due to increased reflux from acid pocket.

Acid pocket in the proximal part of stomach after meals has been shown to be an important mechanism of GERD. The acid pocket is increasingly recognized as a source from which acid reflux events originate. To what extent changes in acidity of the acid pocket contribute to the therapeutic effect of alginate antacid formulation is inconsistent. The other findings suggested that the main mechanism of action for the alginate-antacid combination is to displace the post-prandial acid pocket rather than mechanically containing it.

Therefore, the outcomes of the study will allow us to determine whether late night supper worsen acid pocket, night time reflux and symptoms and whether an alginate antacid preparation (Gaviscon Advance®) is useful in suppression of acid pocket, night time refluxes and symptom (s). A benefit is that this study may inform doctors and advise participants of GERD side-effects of late night supper and how Gaviscon Advance may help.

Eligibility Criteria:
Inclusion Criteria:

1. Aged greater than or equal to 18 years and less than or equal to 70 years.
2. BMI \>27.5 (based on kg/m2)

4. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or alginate preparations, except those administered as part of study procedure.

Exclusion Criteria:

1. Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous or current peptic ulcer disease.
2. Those with a history of upper GI surgery prior to this.
3. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants).
4. Those who had any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate and calcium carbonate
5. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures.
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn's Disease.

The purpose of this study is to determine whether a probiotic containing Lactobacillus Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active colonic Crohn's disease

The aetiology of Crohn's disease is still not known. In the recent years there has been an increasing interest in the relationship between the gastrointestinal flora and gut function. Several studies have shown promising results for the use of probiotics in patient with inflammatory bowel disease.

Aim: The aim of the current study is to evaluate the effect of a probiotic suspension in patients with active colonic Crohn's disease.

Methods: The study is a two-centre, randomised placebo-controlled, and double-blind trial. Patients above the age of 18 years, attending our out-patient clinic, can be included if they have Crohn's disease in the colon or colon and small bowel and have active disease with a CDAI: 220-400. Patients are not included if they have undergone larger bowel resections, have been treated with antibiotics within the last two months, if dose of prednisolone has been changed within the last 4 weeks, or dose of immunosuppressives has been changed within the last 2 months. During the study period no changes in medication is allowed. During an 8 week period patients are treated with a combination of lactobacillus rhamnosus strain 19070-2 and lactobacillus acidophilus strain 18911-2 (10EE9 colony forming unit/ml). Freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested once daily, in the evening.

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed Crohn's disease of the large bowel or large and small bowel according to established criteria.
* At least one prior episode of active disease
* Stoolcultures and microscopies without pathogenic bacteria or parasites
* CDAI 220-400
* Informed consent

Exclusion Criteria:

* More than 15mg of prednisolone daily (or equivalent)
* Changes in dosage of glucocorticoids during the last four weeks prior to inclusion
* Changes in dosage of Azathioprine during the last 3 months prior to inclusion
* Antibiotic treatment during the last two months prior to inclusion
* Symptoms of Crohn's disease assumed to be caused by mechanical obstruction og abscesses
* Long term treatment with NSAID or colestyramine
* Pregnant and lactating women
* Bowel resections removing more than 100 centimetres of small intestine or any colonic resection other than ileo-cecal resection
Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion

This project will investigate the safety and effectiveness of human amniotic epithelial stem cells for treatment of severe refractory Asherman's syndrome.

Asherman's syndrome is an gynecological disorder caused by the destruction of the endometrium due to repeated or aggressive curettages and/or endometritis. As a result, there is a loss of functional endometrium in multiple areas and the uterine cavity is obliterated by intrauterine adhesions, which results in amenorrhea, hypomenorrhea, infertility and recurrent pregnancy loss. Transcervical resection of adhesion (TCRA) is the main treatment for Asherman's syndrome; so far the effect is usually poor in moderate to severe refractory cases.

Human amniotic epithelial stem cells (hAESCs) are derived from human amniotic epithelium. hAESCs retain the characteristics approximating to embryonic stem cells. Animal experiments have shown that the endometrial thickness and fertility of mice was significantly improved after intrauterine therapy with hAESCs. To further explore the role of hAESCs in Asherman's syndrome patients, this project will evaluate the safety of hAESCs and find an effective treatment protocols.

Eligibility Criteria:
Inclusion Criteria:

* 1. Previously diagnosed as uterine adhesion, after the operation of TCRA and the postoperatively standardized hormonal replacement therapy(HRT) , recently diagnosed with refractory Asherman's syndrome or endometrial atrophy(EA);
* 2. According to the American Fertility Society(AFS) classification in 1988, patients are diagnosed of AS or EA stageⅢ-Ⅳ confirmed by hysteroscopy;
* 3. Elimination of infertility, recurrent spontaneous abortion or hypomenorrhea caused by other diseases;
* 4. Be willing to maintain an HRT cycle medication throughout the study, unless it is not tolerated;
* 5. Normal blood coagulation, liver, heart, and kidney function, absence of HIV, Hepatitis B or C, syphilis and psychiatric pathology;
* 6. Be willing to complete the study and sign the consent form.

Exclusion Criteria:

* 1. Patients with severe internal disease;
* 2. The patients are suffering from gynecologic inflammation or active genital tubercle bacillus;
* 3. The patient has other uterine diseases or the abnormal uterine cavity which can't be restored by surgery;
* 4. Infertility due to a man's cause;
* 5. The patient has a previous history of cancer and is undergoing radiotherapy or chemotherapy;
* 6. HIV positive
* 7. Active hepatitis B or C infection, syphilis seropositive
* 8. Laboratory routine check index abnormality, such as Hb（hemoglobin）\<8.0 g/dL,WBC（white blood cell count）\<3,000/ml, platelet counts\<75 000/mm3, AST（glutamic oxalacetic transaminase）\>ULN（upper limit of normal），ALT（Glutamic pyruvic transaminase）\>ULN and so on;
* 9. Patients have any complications that may interfere with safety or efficacy or predict life expectancy of less than 24 months;
* 10. Mental illness in the past 6 months;
* 11. Patients have a history of drug or alcohol abuse or dependence in the past two years;
* 12. Unable or unwilling to give informed consent.