cyrilzakka/clinical-trials huggingface dataset:
Functional and Morphologic Aspects of Intravitreal Triamcinolone for Uveitis-associated Cystoid Macular Edema

Purpose:

To evaluate the effect of intravitreal triamcinolone acetonide (IVTA) on uveitis-associated cystoid macular edema (CME) using high resolution optical coherence tomography (SDOCT) in conjunction with thorough visual function testing.

Methods:

28 patients with uveitis-associated CME were examined before intravitreal triamcinolone injection (IVTA) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. Retinal anatomy was evaluated using Cirrus HD-OCT (Carl Zeiss Meditec). Visual function testing consisted of assessing ETDRS distance visual acuity (VA), reading acuity and reading speed using a standardized German-language test (Radner Reading charts), contrast sensitivity using Pelli-Robson Contrast Sensitivity charts and fundus-controlled microperimetry using the MP-1 Microperimeter (Nidek). Here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. The changes of retinal anatomy over time were compared to the respective outcome of visual function.


Eligibility Criteria:
Inclusion Criteria:

* intraocular inflammation
* able to read
* \> 18 years old

Exclusion Criteria:

* cataract
* amblyopia
* dyslexia
* already applicated intravitreal triamcinolone for current cystoid macular edema
Surgical Approach for Pilonidal Disease

In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients will be divided into two groups as Un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Operation time, hospital stay time, return to work time, recovery time, Time to walk without pain, days, Time to sit on the toilet without pain, days, Postoperative VAS and recurrence will be compared between both groups

In our hospital, between January 2013 and January 2017, those operated with the Modified Limberg flap method after the Rhomboid excision due to pilonidal disease, and those operated with the un-roofing curettage method will be screened retrospectively. Patients who are well followed up will be included in the study. Demographic features will be recorded. Patients will be divided into two groups, the un-roofing curettage group (UC group) and the Modified Limberg Flap group (LF group). Surgery time, hospital stay, return to work time, recovery time, painless walking time, days, painless sitting time in the toilet, days, postoperative VAS, and recurrence will be compared between both groups. In addition, mobilization time, days, recovery time, days, exclusion time, days, wound infection, wound distribution will be compared between groups. The results will be analyzed with the SPSS statistics program. Factors affecting recurrence wound infection, recovery time, hospital stay, operation time, early mobilization will be evaluated by univariate and multivariate logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 and 70
* Patients with sufficient registration information
* Telephone-accessible patients

Exclusion Criteria:

* Patients under the age of 18
* Patients over 70 years old
* Common gluteal disease
* Diabetes mellitus
* Connective tissue disease
Wireless US-guided CVC Placement in Infants

Background: Neonates and small infants with congenital cardiac disease undergoing cardiac surgery represent major challenges facing pediatric anesthesia and perioperative medicine. Aims: We here aimed to investigate the success rates in performing ultrasound guided central venous catheter insertion (CVC) in neonates and small infants undergoing cardiac surgery, and to evaluate the practicability and feasibility of thereby using a novel wireless ultrasound transducer (WUST).

Methods: Thirty neonates and small infants with a maximum body weight of 10 kg and need for CVC before cardiac surgery were included in this observational trial and were subdivided into two groups according to their weight: \< 5 kg and ≥5 kg. Cannulation success, failure rate, essential procedure related time periods, and complications were recorded and the clinical utility of the WUST was assessed by a 5-point Likert scale.


Eligibility Criteria:
Inclusion Criteria:

neonates and small infants with a maximum body weight of 10 kg and need for insertion of a CVC before cardiac surgery at our institution

Exclusion Criteria:

* missing consent for study participation \>10 kg body weight
* emergency surgery
* central venous catheter in situ
Exogenous Ketones and Behavior

The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.

This study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. Using a within-subjects, randomized, crossover design, participants will undergo two phases: one with the ketone ester supplement and one with a calorie- and taste-matched placebo. The study includes four lab visits: visits 1 and 3 mark the first day of each intervention, while visits 2 and 4 mark the last day. During each visit, participants will complete behavioral tasks, questionnaires, and blood tests. Additionally, participants will record their food intake via an app and collect stool samples throughout the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate
* Fluent in German
* Physically healthy. No regular medication
* No drug use 1 week prior to the study
* BMI 18-31 kg/m2

Exclusion Criteria:

* Former or current illnesses of:
* Brain or mind (including eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache; depression or anxiety disorder excluded)
* Heart or blood circulation
* Gastro-intestinal or endocrine disorders
* Liver or kidney disorders
* Electrolyte imbalance
* Other serious past or present medical conditions (for example, metabolic syndrome, diabetes, cancer)
* Pregnancy
* Extreme athletes (\>2h/day intense work-out; casual cycling or walking is ok)
* Menopause (post menopause is ok)
* Ketogenic diet, ketogenic supplement intake, intermittent fasting or calorie restricted diet during preceding 4 weeks of study participation
* Fear of blood draw
Chiropractic Dosage for Lumbar Stenosis

This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects will be evenly randomized into four groups of either flexion distraction (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo control visits. The study is designed: (1) To determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) To determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 50 years old with lumbar spinal stenosis
* Impingement of the cord and/or exiting nerve roots evidenced on spine imaging studies
* Symptomatic with current pain in the back and/or one or both of the legs.
* Symptoms must have been present for at least six months with an insidious onset

Exclusion Criteria:

* Congenital stenosis or other spine deformities such as current spinal fractures, spinal infections, or tumors of the spine
* Prior lumbar spine surgery such as laminectomy, spinal fusion, or discectomy that lacks stability or occurred within the past 3 months.
* Currently pregnant or nursing
* Co-morbid conditions that may preclude a person from participating in active care (laying prone on a treatment table or completing exercises) and outcome measures (Treadmill Testing, completion of questionnaires), such as severe cardiopulmonary disorders (i.e.: severe coronary artery disease, recent myocardial infarction, or vascular claudication), neuromusculoskeletal disorders (i.e.: disabling hip or knee arthritis; trochanteric bursitis; piriformis syndrome; need for assisted ambulation), or brain disorders (i.e.: dementia or Alzheimer's Disease)
* Active conservative care such as physical therapy or chiropractic care for lumbar stenosis (excluding the use of oral medications or daily at-home exercises for general well-being)
* Cauda equina symptoms (i.e.: perianal numbness; loss of bowel and/or bladder control)
* Not fluent or literate in the English language. We will not be able to provide multiple translators within this pilot study
* Current or future litigation for low back or leg pain
Comparison of Measures of Plasticity

Neuroplasticity refers to the ability of the nerve cells to modify their structure or function in response to injury or insult, or other environmental stimuli, with these changes outlasting the period of exposure. Plasticity may be observed as short term or long term changes. In humans, neuroplasticity can be readily assessed in the motor cortex, as excitability changes are demonstrated in the degree to which peripheral muscles are activated, seen through changes in motor-evoked potentials (MEPs). In this study, a number of approaches to assessing neuroplasticity will be evaluated: Paired-associative stimulation (PAS), Theta Burst Stimulation (TBS), which is a form of transcranial magnetic stimulation (TMS) and protocols that combine these two. In addition, participants will complete a computerised 'rotor pursuit task' designed to provide a measure of motor learning.

The investigators aim to find the most efficacious (defined by greatest number of responders and effect size as seen in an increase in MEP amplitude) brain stimulation protocol. The investigators will expose the same participants to four excitatory conditioning stimulation paradigms, with each session separated by at least a week.

Our hypotheses include:

The four conditioning stimulation protocols should increase motor cortical excitability, the investigators therefore expect there to be a significant increase in participant MEPs, with a positive correlation in the increase ofMEP amplitude of the protocols. The investigators do however expect that due to the principles of homeostatic metaplasticity, that the protocols preceded by cTBS will show greater MEP change, due to the lowering of the threshold for LTP plasticity induction. In addition, the investigators expect that an increase in the motor learning manifest by the rotor pursuit task and for there to be a correlation in participants between the increase in MEP amplitude and the improvement in time on target (TOT) shown in the motor learning task (MLT).


Eligibility Criteria:
Inclusion Criteria:

* healthy controls
* those suffering depression
* aged

Exclusion Criteria:

1. Significant Neurological illness, including epilepsy
2. Alcohol use above NHRMC guidelines
3. Illicit drug use
4. Electronic implant; such as cochlear implant or pacemaker
5. Musculoskeletal disorder
Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery

Although the ERAS program is widely used in elective procedures in many surgical subspecialties, the place of this program in emergency surgery remains uncertain probably because of the significant challenges in applying all ERAS pathways in the emergency setting. Nevertheless, the ERAS program is often modified in elective procedures on an individual and/ or institutional basis and thus may also have a role in the emergency setting albeit in a modified form.

The cases will be randomized simply into two groups, Group (A) for conventional care and Group (B) for ERAS. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited. The sealed envelope method will be used for randomization.

Both groups will have pre-operative ryle inserted, urinary catheter applied, Tracheal intubation and with General anesthesia, exploration laparotomy Group (A) Fatsing for at least 6 hours pre-operative, No restriction of IV fluids and traditional analgesia including opiates. Post-operative Ambulation-as per patients' own request, Removal of urinary catheter when patient ambulates, patient will keep fasting for 3 days postoperative, oral fluids for 3 days, semi-solid for another 3 days and then can take full diet, removal of nasogastric tube just before starting oral fluids, drain removal just before discharge.

Group (B) Preoperative information, education and counselling, If possible, Clear fluids are allowed up to 2 h and solids up to 6 h prior to induction of anaesthesia, Short acting anesthetic agents,avoid opioid agents, Post operative nausea and vomiting prophylaxis, Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off, Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward, Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube, Removal of urinary catheter-after weaning from the effect of general anesthesia and drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.

Eligibility Criteria:
Inclusion Criteria:

* Pateint presented with acute abdomen necessitating urgent GIT surgery

Exclusion Criteria:

* Known Chronic kidney disease/ Chronic liver disease patients Patients with history of chronic steroid abuse. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.

Patient presented with Acute Appendicitis or Acute Cholecystitis. Patient refusing for consent
Effect of Bra Use During Radiotherapy for Breast Cancer Radiotherapy

This prospective randomized study investigated the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity when wearing and not wearing a bra during radiotherapy for patients with breast cancer.

Post-surgery radiotherapy to the breast is standard treatment after breast-conserving surgery in patients with breast cancer. In order to apply the latest radiation therapy technologies, such as intensity-modulated radiotherapy, it is important to maintain the correct posture. However, due to the nature of the breast made of soft tissue, it is difficult to maintain the same breast shape during each treatment. This is especially difficult for large, ptotic breasts. Accordingly, we developed a bra for breast cancer patients in order to perform accurate radiotherapy. It was designed to fix the breast using bands in various directions so that its shape and position can be fixed during radiation treatment.

This is a prospective, randomized controlled study to evaluate the effects of using a bra for breast cancer patients on the reproducibility of breast shape, radiation dose irradiated to the lungs, heart, dose distribution, patient satisfaction, and treatment toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically confirmed invasive breast cancer or ductal carcinoma in situ
2. Patients eligible for whole breast irradiation after partial mastectomy
3. Adults over 20 years old
4. Patients with good overall performance (ECOG PS 0-1)

Exclusion Criteria:

1. Recurrent breast cancer patients
2. Patients who have previously received radiation therapy to the ipsilateral breast
3. Patients who underwent breast reconstruction
4. Bilateral breast cancer
5. Patients with skin diseases such as contact dermatitis
Compassion Fatigue in ED Providers

This study will assess compassion fatigue among healthcare providers in a single emergency department (ED) using the Professional Quality of Life (ProQoL) scale.


Eligibility Criteria:
Inclusion Criteria:

* Currently employed as a health care provider in the emergency department. All eligible individuals will be 18 years and older.

Exclusion Criteria:

* Individuals that are not currently employed in the emergency department
VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naïve Participants With Genotype 1 Chronic Hepatitis C Virus Infection

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naïve participants with chronic HCV genotype 1 infection.

This is a randomized (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve study participants with chronic hepatitis C virus (HCV) genotype 1 infection.

Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the participant's treatment response on week 4) as 1,000-1,200 mg per day. After the end of treatment (Week 24, Week 48, or at early discontinuation of all study drugs), participants with undetectable HCV RNA at end of treatment will be required to attend follow-up visits until Week 72 safety/tolerability assessments will be performed throughout the treatment period and during the follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL
* Patients should not have had any previous treatment for hepatitis C
* Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
* Patients with cirrhosis should have serum alpha-fetoprotein (AFP) \<= 50 ng/mL. If AFP \> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

* Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
* Patient has a pre-existing psychiatric condition
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Double-dose Valsartan Monotherapy in Hypertension Treatment: an Effectiveness and Safety Evaluation in Chinese Patients.

To evaluate efficacy and safety of valsartan 160mg in Chinese hypertensive patients.


Eligibility Criteria:
Inclusion Criteria:

* Naive primary hypertension patients or primary hypertensive patients on mono antihypertensive therapy:
* All treatment-naive patients need to have 140mmHg≤MSSBP\<180mmHg and 90mmHg≤MSDBP\< 110mmHg at visit 1
* For patients on mono antihypertensive therapy, MSSBP/MSDBP should \<160/100mmHg at visit 1 (the beginning of screening period); and at visit 2(the beginning of theraputic period), they should have MSSBP≥140 mmHg and \<180mmHg AND MSDBP≥90 mmHg and \<110mmHg

Exclusion Criteria:

* Severe hypertension
* Malignant hypertension
* Secondary hypertension
* Renal dysfunction(serum creatinine \> 2.0mg(176.8μmol/L)at visit 1)
* Hepatic disease
* History of hypertensive encephalopathy or cerebrovascular accident within 6 months
* History of myocardial infarction, coronary revascularization within 6 months
* Type 1 diabetes mellitus
* patietns with HbA1c \>8% at visit 1
* Women in pregnancy and lactation
* Potentially fertile female patients not using effective contraceptive methods
* Be allergy to study drug.

Other protocol defined inclusion/exlusion criteria may apply
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines

This is a single center, randomized, double-blind and placebo controlled clinical study to evaluate the efficacy and safety of brightening microneedle patch on facial solar lentigines. Subjects who are 30 to 65-year-old with solar lentigines on their faces will receive brightening microneedle patches on facial solar lentigines once a day for 4 weeks. Afterwards, facial images and skin detectors will be used to analysis their skin, according to various skin tone indexes and skin response score sheets.

Method: 35 subjects, Fitzpatrick Skin Type II to IV. Each subject has at least two brown solar lentigines on the face, and the two spots are independent, each with a clear boundary and diameter ≥ 0.5 cm.

This trial includes 1 screening visit (Day -1), wash-out period (2 weeks before the trial), trial period (4 weeks in total), and 3 return visits for detecting (baseline detecting at the end of the wash-out period, the 2nd week and the 4th week of the trial period).

Eligibility Criteria:
Inclusion Criteria

1. Men or women between 30 and 65 years old (inclusive);
2. The PI determines the subject's skin type as Fitzpatrick Skin Type II to IV;
3. The PI's diagnosis is that the subject has at least two brown solar lentigines on the face, and the two spots are independent, each with a clear boundary and diameter ≥ 0.5 cm;
4. The subject can understand and follow the requirements, instructions and restriction of the plan;
5. The subject signs patient consent form in writing.

Exclusion Criteria

1. The PI's diagnosis is that the subject has tissue mutation, inflammation or other lesions on the face;
2. Those who have received aggressive facial treatments within the past six months, including laser, IPL, RF (radio frequency), HIFU(high-intensity focus ultrasound), or dermal filler injection;
3. Those with a history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, keloid and so forth;
4. Those who have a history of allergies to the product ingredients of the brightening micro-needle patch, the moisturizer or the sunscreen provided by the trial;
5. Pregnant or lactating women;
6. Those who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs within 21 days before entering the trial;
7. Those who have smoking habits within 12 months before entering the trial;
8. Those who have used any skin medication on the face within 30 days before entering the trial, determined by the PI to have effect on this study;
9. Those who have participated in other clinical trials within 30 days before entering the trial;
10. Those who are currently undergoing medical treatment and their ability to participate in this trial will be affected;
11. Those who the PI considers to be unsuitable to join this trial.