cyrilzakka/clinical-trials huggingface dataset:
Combined Effects of Low Level Laser Therapy and Kabat Technique in Patients With Bell's Palsy

The objective of this current study is to determine the combined effects of Low-Level Laser Therapy (LLLT) and the Kabat technique on quality of life, synkinetic movements and functional outcome in patients of Bell's palsy

Bell's palsy is an acute condition which occurs by the damage of 7th cranial nerve along its course at the level which is distal to Pons. Basically it is an idiopathic facial condition.

The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes equally. This study aims to see combined effects of Low Level Laser Therapy and Kabat technique in the treatment of Bell's palsy.

Synkinesis, which is described as an involuntary movement in one part of the face produced during voluntary movement in another region of the face, is a problematic Bell's palsy sequel. The mechanism behind the formation of synkinesis is unknown. According to the predominant idea, damaged axons regenerate abnormally, innervating facial muscles that weren't originally innervated. The yearly incidence of Bell's palsy is 15 to 30 per 100,000 people, which affect both sexes equally.

Kabat Technique is neurorehabilitation technique that uses diagonal and spiral patterns for movement in conjunction with stretch and resistance and other PNF techniques to reinforce neuromuscular recruitment. It mainly concerns the stimulation of these muscles: Orbicularis occuli, ztgomaticus, Levator labii, nasalis, buccinator, frontalis, corrugator.

For all BP patients, including those who are unable to take corticosteroids due to diabetes or hypertension, laser therapy offers a non-invasive, painless means of treatment. However, just a few researches have examined the effectiveness of low- dose laser therapy in BP patients.

Low Level Laser Therapy has the potential to promote nerve regeneration, reduce inflammation, and accelerate tissue healing in the affected facial nerve. On the other hand, the Kabat technique focuses on restoring neuromuscular control and improving muscle function. By combining Low Level Laser Therapy and the Kabat technique, a synergistic effect may be achieved, maximizing the potential benefits of both interventions. Therefore, this study aims to determine the specific parameters and protocols for the combined use of Low Level Laser Therapy and the Kabat technique in Bell's palsy

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* Both genders will be included
* Unilateral Facial paralysis/paresis
* Patients presented within onset of 12 days - 3 weeks (sub-acute Bell's Palsy)

Exclusion Criteria:

* Previous surgery of facial reconstruction
* Traumatic Brain Injury
* Any other neurological deficit
* Congenital Deformities
* Recurrent Bell's palsy will be excluded
Late Phase II Study of TS-142 in Patients with Insomnia

This is a randomized, double-blind, multi-center, placebo-controlled, parallel-group exploratory study in patients with insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male and female age 20 years or older at the time of informed consent
* Outpatients
* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for insomnia disorder
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting insomnia disorder preceding visit 1
* Patients who meet the DSM-5 criteria for Restless legs syndrome at visit 1
* Patients with comorbid psychiatric disorder(s), including depression, schizophrenia, anxiety
* Other protocol defined exclusion criteria could apply
KTP Laser vs Pulsed Dye Laser for Port-Wine Stains

To compare the efficacy and safety of 532nm KTP laser and 585 nm pulsed dye laser for treating port-wine stains.

Nevus flammeus is a vascular, primarily capillary malformation visible from birth on. In rare cases, it may also affect venous and/or arterial vascular systems of the skin or other organs \[1\]. It occurs in 0.3%-0.5% of the population \[1\], i.e. in about 3-4 out of 1000 newborns, and is thus the most frequent vascular malformation in children. The cause is a permanent dilatation of the capillary vessels, which is caused by a lack of sympathetic nerve fibers or a lower density of the same.

First-line therapy of port-wine stains consists of laser treatment with the long-pulsed dye laser \[2\] with a wavelength of 595nm. Treatment must be performed at least 10 times at intervals of about 8 weeks and leads to lightening and reduction of lesions. In recent years, problems have often arisen in care of port-wine stain patients because dye lasers often failed due to the instability of technology, resulting in treatment delays. Novel long-pulsed KTP lasers may be a sufficient alternative to pulsed dye lasers in treatment of port-wine stains.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years and older
* Good general health, no relevant previous diseases
* Presence of one or more port-wine stains
* Cognitive ability and willingness to give consent (Informed Consent)

Exclusion Criteria:

* Age \< 18 years
* Pregnant and breastfeeding women
* Significant open wounds or lesions in the region to be treated
* Missing consent and/or data protection declarations
FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas

This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for improving surgical planning and providing non-invasive prognostic information in patients with gliomas that have substantial non-enhancing regions. The results will be used to develop larger adequately powered studies.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected diagnosis of intracranial glioma with substantial non-enhancing regions as assessed by contrast enhanced MRI. For the purposes of this study, gliomas with substantial non-enhancing regions are defined as having contrast-enhancing volumes of less than 50% of the total estimated tumor volume. Gliomas that do not have any contrast-enhancing regions are eligible for this study.
* Standard of care surgical resection and/or stereotactic biopsy of the brain tumor planned within 2 weeks of the FDOPA-PET/MRI study.
* At least 18 years of age.
* Measurable disease on MRI defined as tumor measuring at least 1 cm in two perpendicular dimensions.
* Karnofsky performance of \> 50 corresponding to ECOG categories 0, 1, or 2. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 30 mL/min/1.73 m\^2
* Patient or legally authorized representative must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients undergoing PET/MRI: contraindication to gadolinium contrast enhanced brain MRI (i.e., allergy to gadolinium contrast, MRI-incompatible implantable devices, GFR \< 30 mL/min/1.73, and severe claustrophobia). At the discretion of the responsible physician, FDOPA-PET/CT may be performed if PET/MRI is contraindicated or unavailable. If FDOPA-PET/CT is performed, the patient must have undergone a contrast-enhanced MRI for fusion with FDOPA-PET no more than 4 weeks before the FDOPA-PET/CT.
* Prior chemotherapy or radiation therapy for the brain tumor. Prior biopsy or surgical resection of the glioma without additional therapy is not an exclusion criterion.
* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine or serum pregnancy test no more than 3 days prior to FDOPA injection.
Effectiveness of Alcohol 70º vs Soap on Cord Separation Time and the Complication in the Newborn

Evaluate the effectiveness of alcohol 70º compared with soap on cord separation time and the complication rate in the newborn.

Randomized clinical trial, which objective is to assess the effectiveness of 70º alcohol compared with neutral soap on the cord separation time of a selection of newborns. 34 newborns admitted to the maternity ward of the hospital have participated. The study is divided into two phases, hospital and home. The first stage is located in the hospital, where the patients who will become part of the study are chosen. After receiving the informed letting of the legal guardian the second part of this phase is started; which aim is to explain the steps to be followed to make a correct cleaning cord technique. The home phase consists of being in contact with the family through Whatsapp on the 5th day from birth, the day of the cord fall and 5 days after this fall. Making some simple questions with simple answers such as yes or no and with the possibility, or not, of sending a picture of the cord state in each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Availability of legal guardians with knowledge and access to Whatsapp.

Exclusion Criteria:

* Admission in the newborn's room.
* Patients with strong concomitant illness, that limits the planned activities or whose current state contraindicates the incorporation of the program.
* Mother's age \< 18 years old.
* Bad controlled mother's diabetes (at least two digits of blood glucose \<180 mg/dl per day), bad alimentation control and/or non-adherence.
Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.

To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* Documented, signed informed consent to participate in this study
* Age greater than or equal to 18 years
* Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy

Exclusion Criteria:

* Crohn's disease
* Ulcerative proctitis
* Ulcerative colitis extending beyond the splenic flexure
Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study

To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.

Primary Objectives

• To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.

Secondary Objectives

* To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
* To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
* To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
* To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
* To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
* To assess Patient Global Impression of Change (PGIC)
* To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants

Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with pain of the lower extremity from chronic (\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
* Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
* Participants age 18+
* Participants who have completed chemotherapy within the last year at the time of enrollment.

Exclusion Criteria:

* Participants with cognitive dysfunction
* Participants with recent history (\<6 months) of drug or alcohol abuse
* Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Participants with allergies to capsaicin or adhesives
* Pregnant participants
Watchful Living in Improving Quality of Life in Participants With Localized Prostate Cancer on Active Surveillance and Their Partners

This pilot trial studies how well Watchful Living works in improving quality of life in participants with prostate cancer that has not spread to other parts of the body who are on active surveillance and their partners. A social support lifestyle intervention (called Watchful Living) may help African American prostate cancer participants and their partners improve their quality of life, physical activity, diet, and inflammation.

PRIMARY OBJECTIVES:

I. To determine the feasibility of recruiting and implementing a lifestyle intervention for prostate cancer patients and their partners.

SECONDARY OBJECTIVES:

I. To evaluate the preliminary efficacy of a lifestyle intervention in improving diet, physical activity, physical fitness, partner's support, quality of life, and inflammation at the end of the study (month 6).

II. To conduct a process evaluation of the lifestyle intervention. III. Explore participants' satisfaction, likes/dislikes, strengths, weaknesses, and areas of improvement regarding the program.

OUTLINE:

Participants receive an exercise plan and printed materials at baseline. Participants also receive 10 telephone coaching calls over 45-60 minutes weekly during month 1, every 2 weeks during month 2, and every month during months 3-6. Participants complete 2 nutrition counseling sessions before month 3.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as black or African American or Hispanic (patient)
* Be greater than 18 years of age (patient and spouse or intimate partner)
* Have 0-III stage prostate cancer (patient)
* If treated, have completed therapy (e.g., surgery, chemo and/or radiation) (patient)
* Enroll with a spouse or intimate partner (patient)
* Do not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week) (patient and spouse or intimate partner)
* Be ready and able to be physically active, as determined by a physician (letter from a physician or nurse practitioner) (patient and spouse or intimate partner)
* Not participate in another physical activity, diet, or lifestyle program (patient)
* Have a valid home address and telephone number (patient)
* Internet access at home or other location (e.g., work, church, library, community center, etc.) (spouse or intimate partner)
* Patients on active surveillance will be included

Exclusion Criteria:

* They have an active noncutaneous malignancy at any site (patient)
* Had prior radiation therapy for treatment of the primary tumor (patient)
* Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period (patient)
* Are enrolled in another active surveillance protocol (patient)
* Participated in formative focus groups for this study (patient and spouse or intimate partner)
Bolus Insulin Card Calculator Randomised Controlled Study

In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.


Eligibility Criteria:
Inclusion Criteria:

* Age 11 - 18 years old
* Currently using indvidual subcutaneous injections (not CSII)

Exclusion Criteria:

* HbA1c \> 9.5%
* Serious illness
The Efficiency of Video-Based Exercises in Individuals With Stroke

The aim of the study is to compare the video-based balance coordination exercise program and the video-based conventional exercise program in patients with subacute stroke.

Thanks to telerehabilitation, it will be possible for individuals to learn the exercise programs in the most appropriate way and to communicate easily with their physiotherapists with video images. In this way, it will be ensured that individuals can perform their exercises at the optimum level in non-clinical environments. The aim of the study is to compare the conventional home exercise program performed with video-based telerehabilitation and the balance coordination program in subacute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 40 - 65 years
* Having been diagnosed with stroke by a specialist physician and at least 3 months and maximum 6 months have passed since the diagnosis
* No serious medical complications
* Being able to understand verbal and visual commands
* Getting at least 24 points on the mini mental state test
* Able to walk at least 10 m without assistance using crutches or a walker
* Having signed the consent form

Exclusion Criteria:

* Situations that will prevent assessments or communication with the individual
* Being on psychotropic medication
* People with ataxia or any other cerebellar symptoms
* Other problems that would preclude evaluation and/or treatment
A Study of Symptoms and Quality of Life in Patients With Implantable Cardiac Defibrillators (ICDs) and Their Caregivers

The purpose of this study is to better understand symptoms and quality of life in patients with heart disease and implantable defibrillators (ICDs).


Eligibility Criteria:
Inclusion Criteria:

Patients:

* Patient has an ICD
* Age \> 18
* Fluent in English
* Consistent and reliable access to a phone.

Caregivers of Patients:

* Age \> 18
* Fluent in English
* Consistent and reliable access to a phone

Exclusion Criteria:

* Not having an ICD
Irinotecan Versus Only Best Supportive Care for Gastric Cancer

The median survival at progression after first-line chemotherapy for metastatic gastric cancer is about 2.5 months. There are no data which a possible benefit of second line therapy. for this reason a trial which investigates a possible benefit or chemotherapy compared to best supportive care as second line treatment is urgently necessary.

Irinotecan shows response rates of 20% in the first line therapy with high rates od disease stabilization. There are few trials investigating irinotecan in the second line setting. Response rates of 20% are reported in tis setting. Irinotecan is supplied without costs from the company Pfizer.

Metastatic gastric cancer, progressive disease after one palliative chemotherapy

Arm A:

Irinotecan 250/350 mg/m2 q3w

1. Cycle:250mg/m2/ 30min
2. Cycle:If no toxicity\>2° CTC, nor Leuko-thrombopenia\>3° occured, dose is increased to 350mg/m2 Arm B. Best supportive care

Eligibility Criteria:
Inclusion Criteria:

* Patient with histologically proven adenocarcinoma of stomach or the gastro-esophageal junction
* Patient with distant metastases laparoscopically proven operative incurability of an locally advanced gastric cancer or patient with a tumor recurrence after gastrectomy
* Patient with progressive disease under a palliative first-line chemotherapy or progressive disease within 6 months after termination of a first-line chemotherapy, defined as objective progression by imaging techniques according to WHO criteria
* Age 18 and 75 years
* Sufficient liver function, defined as serum-bilirubin \<1,5 mg/dl (1,5 upper normal limit), ALT und AST \< 3x upper normal limit
* Sufficient renal function, defined as serum creatinine \< 1,25 x upper normal limit or creatinine clearance \>60ml/min calculated according to Crockroft-Gault
* Contraction for patient with reproductive potential
* Karnofsky-Index \>60%
* Measurable or evaluable tumor manifestation

Exclusion Criteria:

* Tumor progression later than 6 months after termination of first-line chemotherapy
* KI 50% or less
* Patient who have already received a second line chemotherapy for the metastatic setting (adjuvant chemotherapy and one line of palliative chemotherapy os allowed, biologic prior therapies are allowed)
* Prior or current second malignancy despite of basal carcinoma of the skin and curatively treated carcinoma in situ of the cervix
* Uncontrolled infection
* CNS metastases
* Other severe medical illness
* Prior major surgery less than 2 weeks ago
* Parallel treatment with another experimental therapy
* Parallel treatment with another therapy aiming at tumor reduction
* Chronic diarrhea, subileus
* Chronic inflammatory bowel disease or intestinal obstruction
* Pretreatment with irinotecan
Pterygomaxillary Disjunction With Interpositional Y-shape Plate in Patients With Temporomandibular Joint Derangement

Temporomandibular joint internal derangement (TMJ ID) is the most frequent type of temporomandibular disorder (TMDs)which is managed by different therapeutic modalities. it begins with conservative methods like medical treatment, physiotherapy, thermotherapy, and bites appliance therapy. Surgical intervention is a controversial issue in cases not responding to conservative methods. A novel minimally invasive surgical technique which is extracapsular trans oral (Pterygomaxillary disjunction) has been advocated as a minimally invasive extracapsular technique that preserves TMJ integrity.


Eligibility Criteria:
Inclusion Criteria:

* Patients without relevant disease
* Patients refractory to conservative treatment \> 6 months.
* Patients are diagnosed, with unilateral/bilateral anterior disc displacement without reduction, clinically and by MRI recently.
* No previous TMJ surgery.
* No previous maxillofacial trauma.

Exclusion Criteria:

* Patients with systemic joint disease (rheumatoid, osteoarthritis, gouts).
* Medically compromised patients contraindicating operation.
* Patients to whom general anesthesia is contraindicated.
* Patient with neuromuscular disorders.
* Patients with any gross pathology of the ear.
* Patient with psychoneurotic disorders.