cyrilzakka/clinical-trials huggingface dataset:
Shock Wave and Spastic Cerebral Palsy Equines Foot

A double-blind randomized controlled study was carried out on 34 children (19 boys and 15 girls) in the age ranged from 7 to 9 years old with spastic hemiplegia were randomly allocated to one of two groups: control or study group. The two groups received traditional therapeutic exercises for 12 weeks. Additionally, study group received rESW (one session/week) on gastrocnemius and soleus muscles (1500 shots/muscle, frequency of 4Hz, energy of 0.030 mJ/mm2). All children were evaluated at baseline, and after 12 weeks by Modified Ashworth Scale, Biodex system 4 isokinetic dynamometer, Gross Motor Function Measure (GMFM-88), dimensions "D" standing and "E" walking, Trost Selective Motor Control Test, and Single Leg Standing Test.

Both groups underwent conventional physical therapy program which included muscle stretching, strengthening exercises, neurodevelopmental techniques, proprioceptive training, and balance and gait training for three months (3 days/week ,1 hour/day).

Study group Subjects in this group received the traditional physical therapy treatment plus true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week) of shock wave intervention. The pressure pulses were focused on the muscle belly of the planter flexor hypertonic muscles. Standard ultrasonic gel was used as a contact medium. A total of 1500 shots with a pressure of 1.5 bar and an energy flux density (EFD) of 0.030 mJ/mm2 were applied with the repetition frequency of shock wave irradiation of 4 pulses per second (Hz). The rESW session lasted about 6 minutes and was painless; thus, local anesthesia was not required.

Eligibility Criteria:
Inclusion Criteria:

* 1) children who could walk independently or with assistive devices ,2) children with motor dysfunction graded as a 1 or 2 on the Gross Motor Function Classification System (GMFCS), 3) children scoring 1or1+ on the Modified Ashworth Scale (MAS), 4) Dynamic ankle contracture which was confirmed if ankle equinus was observed during ambulation and passive dorsiflexion of the ankle could be accomplished beyond the neutral position with knee extended

Exclusion Criteria:

* 1) children older than 9 years or younger than 7 years, 2) previous botulinum toxin type A injection in the gastrocnemius muscle or serial casting of the ankle within 6 months prior to enrollment, 3) fixed ankle contracture, and 4) surgery of the lower limbs in the past 12 months.
A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females between the ages of 18 and 70 with asthma
U-POEM vs CO2-POEM

Multicenter randomized trial comparing post-procedural pain intensity after Per-Oral endoscopic myotomy (POEM) between two types of standard of care insufflation methods (CO2 vs Underwater).

POEM is routinely performed under carbon dioxide insufflation (CO2-POEM) as this gas is more rapidly absorbed than air, which has been shown to reduce gas-related complications.

Water immersion for luminal distension of the GI tract as opposed to carbon dioxide insufflation has been shown to be associated with improved patient satisfaction, safety profile and even higher detection of polyps during colonoscopy in randomized trials

Aim 1. The primary aim is to compare post-procedural pain following U-POEM vs. CO2-POEM.

Aim 2. Compare the proportion of patients that require post-procedural admission for pain management.

Aim 3. Compare the need for analgesic medications for pain control in patients undergoing U-POEM vs. CO2-POEM.

Aim 4. Compare technical and clinical success between U-POEM vs. CO2-POEM. Technical success is defined as successful completion of the procedure whereas clinical success will be defined as an Eckardt score ≤ 3 at the time of follow-up.

Aim 5. Compare and evaluate procedural characteristics between the two groups.

1. Compare procedural time between U-POEM and CO2-POEM.
2. Compare the mean number of coagulations with hemostatic forceps for active intraprocedural bleeding and the mean number of times in which a device besides an electrosurgical knife was required for prophylactic ablation of vessels.
3. Adverse event rate (i.e. bleeding, perforation).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Ability to provide informed consent
* Patient scheduled to undergo POEM procedure for esophageal dysmotility

Exclusion Criteria:

* Inability to provide informed consent
* Any contraindication to POEM as per the endoscopist at the time of endoscopic evaluation (example: esophageal stricture, malignancy).
* Any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
Epidemiological Study to Describe Non-small-cell Lung Carcinoma (NSCLC) Clinical Management Patterns in MENA. Lung-EPICLIN/ KSA

The study is to provide accurate, reliable information on NSCLC clinical management across MENA (Middle East North Africa) countries in order to detect unmet medical needs of this disease, it is a purely observational study; therefore patients are not assigned to a particular therapeutic strategy beforehand by a protocol. Treatment will be according to current clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between April 1st 2011 and March 31 2012, for PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias

Exclusion Criteria:

* According to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.
Physical Activity Enhancement Using Pedometers in COPD

Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.

Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.

Eligibility Criteria:
Inclusion Criteria:

* COPD diagnosis according to GOLD guidelines
* Pack year Index equal or more than 10
* smoking suspended \> 2 months
* older than 40 years old,

Exclusion Criteria:

* any chronic condition that does not allow walking
* participation in a rehabilitation program
* Acute exacerbation in the last two months
Opioid-free Vs Traditional Balanced Anesthesia in Laparoscopic Colorectal Surgery

The goal of this clinical trial is to compare opioid free anesthesia versus opioid anesthesia in patients undergo laparoscopic colorectal surgery. The main question it aims to answer is assess the efficacy of opioid-free anaesthesia respect to postoperative pain control in patients undergoing a laparoscopic colorectal surgery.

Participants will answer a questionnaire during the first 3 days of admission, assessing pain through the visual analog scale (VAS).

The researchers will compare the consumption of opiates during the postoperative period in the opioid-free anesthesia group.

The objective of the study is to know the efficacy of OFA in laparoscopic colorectal surgery. The consumption of opiates will be evaluated according to the VAS scale, defining non-tolerable pain greater than 5. The number of rescues required, the time elapsed until the first rescue and the total consumption of opiates administered will be evaluated.

Other variables that will be evaluated will be safety variables defined as intraoperative complications that require immediate action by the anesthesiologist, interruption of the procedure, or conversion to open surgery.

Other variables evaluated will be postoperative complications:

* Postoperative hypoxemia.
* Incidence of postoperative nausea and vomiting (PONV).
* Postoperative ileus.
* surgical complications.
* medical complications

Eligibility Criteria:
Inclusion Criteria:

( - ) Patients older than or equal to 18 years.

(-) Patients scheduled for laparoscopic colorectal surgery.

(-) Patients with physical status classification (ASA) I-III.

(- ) Patients who have signed the informed consent of the clinical trial

Exclusion Criteria:

(-) Pregnant or lactating patients.

(-)Patients with allergy to any of the drugs or excipients used in the study

(-) Emergency laparoscopic colorectal surgery

(-) Patients with AV block, intraventricular block, or sinus block

(-) Adam-Stokes syndrome.

(-) Patient on chronic beta-blocker treatment with HR \< 50 bpm

(-) Patient with ejection fraction \< 40% known

(-) Epilepsy.

(-) Surgery converted to open surgery

(-) Legally disabled patient

(-) Patients with physical status classification (ASA) IV.
Prevention of Delirium After Bone Marrow Transplantation

The purpose of this study is to find out if using bright light sessions during bone marrow transplant can prevent people from developing confusion also known as delirium.

This is a pilot, double blind randomized study conducted in patients scheduled to undergo bone marrow transplant at the Massachusetts General Hospital. The goal of this study is to look at the usefulness of bright light therapy in the prevention of delirium in a population at high risk for developing this condition.

Delirium can develop in up to half of the people that undergo bone marrow transplant. Symptoms include changes in level of alertness, confusion, and temporary problems with memory and attention. In severe cases, it can be accompanied by agitation, paranoia(overly suspicious), and hallucinations(seeing or hearing things that are not really there).

Bright light uses no medication and is often used to treat seasonal affective depression and multiple sleep disorders. The light boxes are portable and are placed in front of individuals for about 30 minutes every day.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Male or female
* Patients scheduled to undergo HSCT
* English speaking

Exclusion Criteria:

* Previous history of bipolar affective disorder
* On-going delirium
* History of substance abuse/dependence within 6 months prior to HSCT
* History of invasive melanoma. Patients with a history of basal cell carcinoma, melanoma in situ, or squamous cell carcinoma are permitted to enroll if the lesion(s) have been excised with negative margins
* History of medical/dermatological conditions that make skin especially sensitive to light,such as systemic lupus erythematosus (SLE) and/or porphyria
* Eye condition that makes eyes vulnerable to light damage
* Concomitant use of medications that increase sensitivity to sunlight, such as the herbal supplement St. John's Wort
* Established primary insomnia
Comparison of Efficacy and Ocular Surface Disease Assessment Between BRIDIN-T Eye Drops 0.15% and ALPHAGAN-P Eye Drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Comparison of Efficacy and Ocular Surface Disease Assessment between BRIDIN-T Eye drops 0.15% and ALPHAGAN-P Eye drops 0.15% in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Trial

Following 12 weeks of administration of BRIDIN-T Eye drops 0.15%(non preservative) or ALPHAGAN-P Eye drops 0.15%(preservatives) for patients with glaucoma or Ocular Hypertensive Patients. The use of BRIDIN-T Eye drops(non preservative) is less harmful to external ophthalmicus diseases and increase of medication compliance for ophthalmic drugs than the ALPHAGAN-P Eye drops 0.15%(preservatives)

Eligibility Criteria:
Inclusion Criteria:

1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma or ocular hypertension
2. In the case of a person receiving a glaucoma treatment drug, a person who has completed the appropriate in wash-out period for the existing glaucoma drug before the investigational product is administered.
3. Intraocular pressure (IOP) \>/= 15mmHg and \< 40mmHg in each eye using Goldmann applanation tonometry at visit 2
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients with primary closed-angle glaucoma, congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.
2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.
3. Those who have ongoing medical history as intraocular inflamation.
4. Central corneal thickness is not between 470um and 591um.
5. Patients who have received lacrimal passive occlusion within the last three months or who have surgery plans during the clinical trial period.
6. Pregnant or nursing women.
7. Patients judged coexisting disease that could interfere with the completion of the treatment or safety of this clinical trial. Patients that other researchers are determined inadequately
Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India

The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

A single visit will be necessary. After informed consent, and checking of the inclusion and exclusion criteria, investigators will perform measurements with an autorefractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an autorefractometer under cyclopegia.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old
* At least 6 years old and up to 12 years old at time of informed consent and assent
* Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval \[-10.00, +8.00\]
* Cylindrical refractive error between 0 and 4.00 D on both eyes
* Corrected binocular visual acuity in distance vision at least 6/9

Exclusion Criteria:

* Incapable of expressing consent
* All categories of persons particularly protected by law
* Subject in another study which might have an influence on vision or interfere with study assessment
* Less than 6 years old, or 13 years old or above at time of informed consent and assent
* Amblyopia, Cataract, Strabismus.
* Aphakic or pseudophakic (intraocular implant)
* Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye.
* Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus)
* Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...),
* Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology)
Hypofractionated Radiotherapy for Soft Tissue Sarcomas

One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.

Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
* Participant refuses surgery or is aware that surgery is not recommended for them
* Karnofsky performance status \> 60
* Able to understand and sign an informed consent form

Exclusion Criteria:

* Pregnant
* Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
* Unable to undergo imaging or positioning necessary for radiotherapy planning
* Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.
Sleep Actigraphy in Postural Tachycardia Syndrome (POTS)

We propose to use actigraphy (measured by activity watches) as a tool to quantify sleep disturbances in patients with orthostatic intolerance compared with healthy control subjects. In this pilot study, we will test the null hypothesis (Ho) that there are no differences in the sleep quality between patients with orthostatic intolerance and healthy control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with orthostatic intolerance by the Vanderbilt Autonomic Dysfunction Center
* Control subjects will be free of orthostatic intolerance and other major medical problems, free of medications during the study
* Age between 18-65 years
* Male and female subjects are eligible.
* Able and willing to provide informed consent

Exclusion Criteria:

* Overt cause for postural tachycardia (such as acute dehydration)
* Self-report of pregnancy
* Inability to give, or withdrawal of, informed consent
* Other factors which in the investigator's opinion would prevent the subject from completing the protocol
Efficacy Testing of Melon Oil Olive Pressed Candy Products

To assess melon and oil olive pressed candy on skin condition improvement


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 18 years old
* ITA° value 20°-41°

Exclusion Criteria:

* Involuntary subjects.
* Subjects who have a history of skin diseases such as psoriasis, eczema, atopic dermatitis, severe acne; or suffer from other chronic systemic disease.
* Those with known cosmetic, drug or food allergies.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Subjects who have taken oral or topical corticosteroids and other anti-inflammatory drugs in the past 1 month.
* Use of any products or drugs that affect skin color such as fruit acid, salicylic acid (such as Hydroquinone preparations) in the past 2 months.
* In the past 3 months, the test site has used retinoic acid preparations or undergone chemical peeling, laser, pulse light and other medical aesthetic therapists
* Subjects who can not avoid long-term sun exposure
Prostate Ablation Registry and Database for Information, Surveillance, and Evaluation (PARADISE)

Prostate cancer (PCa) is the most commonly diagnosed non-cutaneous cancer of men in the world. In 2023 alone, it is estimated that 288,300 US men will be diagnosed with prostate cancer and 34,700 will die from the disease despite the approval of multiple systemic agents. Due to advances in screening and imaging technology, PCa is now detected much earlier in its disease course. Prostate gland ablation for prostate cancer might provide the option for a "middle" ground between active surveillance (AS) and radical therapy by destroying prostate cancer in a minimally invasive or non-invasive fashion and thus limiting the morbidity. This treatment strategy is increasingly being offered to patients due to low morbidity but the data on long term oncologic efficacy and side effect profile is lacking for such a treatment strategy.

The purpose of this study is to create a database and prospective registry for data collection on patients with prostate cancer undergoing prostate ablation for the management of prostate cancer. Patients with biopsy-proven prostate cancer of any Gleason Grade will be entered into the registry as long as prostate ablation is used as the prostate cancer management modality. Historical data from 2017 to the present time will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* ≥22 years of age
* Histologic diagnosis of prostate cancer
* Scheduled to undergo or have already undergone ablation of the prostate as part of routine clinical care or any ongoing clinical trials
* Prostate ablation performed with any of the following energy sources: cryotherapy, high-intensity focused ultrasound, irreversible electroporation, laser, microwave, radiofrequency ablation, or photodynamic therapy. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins

Exclusion Criteria:

* Under 21 Years of age.
Markers for Chronic Obstructive Pulmonary Disease (COPD)

The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).


Eligibility Criteria:
Inclusion Criteria:

Healthy non-smokers

* FEV1 \>80% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists

Current smokers

* FEV1 no less than 80% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years

Moderate COPD

* FEV1 40-59% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years\*\*

Severe COPD

* FEV1 \<40% predicted
* FEV1 reversibility of \<10% after inhaled (beta2-agonists
* Smoking history of \> 10 pack-years

Exclusion Criteria:

* FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
* Asthma
* unstable disease (FEV1 \<35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.