cyrilzakka/clinical-trials huggingface dataset:
Low Level Laser Therapy Associated With Exercise in Subacromial Impingement Syndrome

Objectives: The objective was to compare low level laser therapy (LLLT) therapy versus low LLLT therapy in combination with an exercise or exercise only on pain, range of motion (ROM), functionality, and activity limitation in patients with subacromial impact syndrome.

Design: Randomized and placebo-controlled clinical trial.

Setting: The setting for the study was the Municipal Clinic of Barueri, São Paulo, Brazil.

Participants: 60 patients with subacromial impact syndrome were randomly assigned in three groups.

Interventions: Group I, experimental (n=21) treated with low level laser therapy and exercises; Group II, experimental (n=21) treated with exercises; and Group III, experimental (n=18) treated with low level laser therapy. Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session.

Main outcome measures: Visual Analogic Scale (VAS) score, Shoulder Pain and Disability Index (SPADI), goniometer, Modified-University of California at Los Angeles Shoulder Rating Scale (UCLA), recorded before and after treatment.

In the groups that received low level laser therapy (LLLT), energy was irradiated over three insertion points in the supraspinatus muscle region, three points on the bursa subacromial, and three points along the bicipital groove, at 3 Joules per point. Total dose per shoulder was 27 Joules per treatment, using a previously calibrated Irradia Class 3B (Stockholm, Sweden). Pen's semiconductor consisted of gallium arsenide with a wavelength of 904 nm, frequency of 700 Hz, average potency of 60 mW, peak potency of 20 W, pulse duration of 4.3 ms, and 50 seconds per point (0.5cm2 area). The parameters followed the recommendation of the World Association of Laser Therapy for subacromial impact syndrome.

The participants received application of laser three times or week for eight weeks.

The groups treated with exercise followed the same training program. Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds.

The participants performed the exercises three times a week for eight weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of subacromial impact syndrome
* Age range: 30-75 years
* Both genders

Exclusion Criteria:

* cancer,
* diabetes,
* symptomatic shoulder osteoarthritis,
* surgery or previous fractures in the humeral head of the shoulder,
* history of acute trauma, calcification of the articular rotator tendon,
* total tendon rupture,
* cervical myofascial syndrome,
* radicular pain,
* inflammatory rheumatic disease,
* neurological disorders,
* depressive syndrome
* use of antidepressants,
* use of anti-inflammatory medications
* use anxiolytics
Infraorbital Nerve Involvement on Magnetic Resonance Imaging in European Patients With IgG4-related Ophthalmic Disease

Systematic medical chart and imaging files review of patients presenting with non-lymphoma, non-thyroid-related orbital inflammation. The review aims at comparing the frequency of MRI infra-orbital nerve enlargement, between patients diagnosed with an IgG4-related ophthalmic disease (IgG4-ROD) and other patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from acute orbital inflammation

Exclusion Criteria:

* Thyroid disease
* Lymphoma
The Effect of Modified Olfactory Training on Postoperative Olfactory Dysfunction in Patients With CRS

The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are:

Is it possible that the device can treat postoperative olfactory dysfunction in patients with chronic sinusitis? Compared to the conventional device, how efficient is the modified olfactory training device for treating postoperative olfactory dysfunction in patients with chronic sinusitis?

Endoscopic sinus surgery is an effective treatment for treating olfactory dysfunction related to chronic rhinosinusitis. However, recent studies have shown that most patients experience a return of olfactory function to preoperative levels within months to a year after surgery. Clinically, olfactory training after endoscopic sinus surgery has been proven beneficial for the olfactory recovery.

The improved olfactory training device, based on a nasal bidirectional drug delivery system, can increase the deposition rate in the olfactory fissure region and improve the efficiency of olfactory training.

In this study, the investigators planned to recruit 213 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.

Eligibility Criteria:
Inclusion Criteria:

1. A diagnosis of CRSsNP based on the European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS20).
2. The duration after endoscopic sinus surgery is 3months.
3. Olfactory dysfunction confirmed with the Sniffin's Sticks psychophysical test (TDI score≦30.5) .
4. Willingness to participate in this study and sign the informed consent form (ICF).

Exclusion Criteria:

1. Patients with olfactory impairment due to traumatic, congenital, toxic/drug-induced causes, tumors, or post-upper respiratory infections.
2. Lund-Mackay olfactory cleft score \> 0.
3. Patients with severe comorbidities, such as malignant tumors.
4. Current or planned pregnancy prior to the end of study.
5. Patients who are unable to complete the study or are unable to comply with the requirements of the study (such as inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use, previous delinquent behavior)
High-dose Accelerated Theta Burst Stimulation for the Treatment of Alcohol Addiction

This is a two-arm randomized placebo-controlled trial in which 72 patients with alcohol addiction are treated with high-dose accelerated intermittent theta burst stimulation (TBS).


Eligibility Criteria:
Inclusion Criteria:

* alchohol dependence according to ICD-10 (F10.2)
* desire to reduce or abstain from alcohol drinking
* male or female
* 18-65 years
* residency in Germany, German speaking
* written informed consent

Exclusion Criteria:

* contraindications for transcranial magnetic stimulation (electric devices or metal parts in the body such as pacemaker)
* relevant neurological or internistic diseases according to study investigator
* treatment with TMS in the past
* participation in other trials during treatment
* pregnancy or breatfeeding
* positive breath test for alcohol
* legal care and placement in a psychiatric hospital
* co-medication with disulfiram, acamprosate, topiramate, baclofen, naltrexone, or nalmefene
* acute psychiatric comorbidity that requires inpatient treatment or medication readjustment (\<1 month)
* severe chronic psychiatric illness (schizophrenia, schizoaffective disorder, bipolar disorder)
* patients who are unable to complete study questionnaires or follow-up questionnaires (in the opinion of the investigators)
Comparison of Breast Feeding Counseling and Video Demonstration on Exclusive Breast Feeding Rates at 6 Weeks

The investigators hypothesize that counseling of mothers will increase exclusive breast feeding rates at six weeks postnatal age. In developing countries like India,there is shortage of staff and the number of newborns cared is huge. So counseling of mothers for breast feeding becomes difficult. In such a situation using audio-visual aids may be a more practical option to increase breast feeding rates. Therefore the investigators will compare the use of video demonstration with counseling for exclusive breast feeding.

1. Study design - Randomized controlled trial.
2. Inclusion criteria- All mothers who deliver at term at Deen Dayal Upadhayay Hospital \[DDUH \]whether booked or unbooked.
3. Exclusion criteria -

   1. Sick mother who is unable to communicate
   2. Congenital malformation
   3. Babies admitted in neonatal intensive care unit
   4. HIV positive mother
   5. Mother on chemotherapy/planned for chemotherapy.
4. Setting of the study - The study will be conducted at postnatal wards of DDUH, New Delhi
5. Period of study-January 2009 to December 2009.
6. Sample size- We did a pilot study to see the baseline exclusive breast feeding rates at six weeks in mothers who delivered at DDUH. The baseline exclusive breast feeding rates at six weeks is 60%. Expecting a 10% absolute increase in exclusive breast feeding rates and alpha=0.05 and power beta=80% our sample size is 376 per group. Taking into account the loss to follow up of 20% we plan to enroll 470 mothers per group. So our sample size is 1410 mothers.
7. Ethics and consent-Ethical clearance will be obtained from ethical committee of DDUH. Written and informed consent will be taken from the mothers before enrolment.
8. Randomization - It will be an open-label randomized controlled trial. Random numbers will be obtained from a computer generated table. Mothers will be grouped into three groups: counseling group, video group and control group. The codes will be kept in sealed opaque envelopes. There will be allocation concealment since the mothers and the principle investigator will be unaware of the group to which they will be randomized.
9. Methods- The principle investigator will visit the postnatal wards daily except on holidays and look for the eligible mothers who will be asked for written and informed consent. Those who give the consent will be enrolled and randomized to counseling group, video group and control groups. The mothers in the intervention group will be counseled along with the husband and mother/mother-in-law/female caretaker. The mothers in the video group will be shown a video on breast feeding. The baseline characteristics of the three groups will be recorded. The mothers in the control group will receive standard care.

Eligibility Criteria:
Inclusion Criteria:

* All mothers who deliver at term at Deen Dayal Upadhayay Hospital \[DDUH \]whether booked or unbooked.

Exclusion Criteria:

* Sick mother who is unable to communicate
* Congenital malformation
* HIV positive mother
* Mother on chemotherapy/planned for chemotherapy.
B7-Family Score in Urothelial Carcinoma

Immunotherapy has been found to confer substantial survival benefits to the patients with higher mutation burdens, which become the first biomarker approved by FDA in urothelial carcinoma (UC). Nevertheless, among the patients with high mutation burdens, some still remained refractory to immunotherapy. The B7 family molecules have long been perceived as vital determinant of immune response and may define dominant molecular subsets associated with immunotherapeutic response. Simultaneously, our previous study (Eur J Cancer. 2022,171:133-142) unveiled the potential of B7-H4 as a candidate biomarker to refine the predictive capability of tumor mutation burden (TMB) in immunotherapeutic efficacy based on its significant correlation with TMB in MIBC. We hypothesized that the integration of B7 family molecules with TMB could better identify patients with better response to checkpoint blockade.

In this retrospective study, a total of 1,084 UC patients from 5 independent cohorts were enrolled. We established the B7 Family Score (BFS) by the expression patterns of three B7 family members: PD-L1 (CD274), B7-H3 (CD276) and B7-H4 (VTCN1) based on protein and transcriptomic level respectively. We further investigated the correlation of BFS with genomic features and therapeutic response in UC. In addition, we integrated the BFS with tumor mutation burden (TMB) to better stratify the clinical benefit from PD-L1 blockade and platinum-based chemotherapy.

On the basis of established findings in the prognostic and functional properties of the three B7 family members, i.e., PD-L1, B7-H3, and B7-H4, we employed the IMVigor210 cohort as the discovery cohort to establish the concept of B7 Family Score (BFS). To maximize the prognostic value of the system, we introduced the R package survMisc (0.5.5) in the IMvigor210 cohort to determine the best cut-off value of mRNA expression level of the B7 family members (i.e. CD274, CD276, and VTCN1) by calculating the minimum log-rank P value accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Patients with muscle-invasive bladder cancer receiving radical cystectomy have been included in this study.

Exclusion Criteria:

* Patients with non-muscle invasive bladder cancer were not eligible in this study.
Home-Exercise vs General Physical Activity: Effect on Health-related Quality of Life

The purpose of this randomized controlled trial is to evaluate the effectiveness of an exercised-based programme developed for older people admitted at a geriatric outpatient clinic and to see if a home-exercise program enhances the effect. The outcomes considered is health-related quality of life, balance-self confidence, balance and mobility.

Older people discharge from hospital often have decreased functional and physiological reserve that make them vulnerable of being dependent of others. Research have shown that older people discharge from hospital are vulnerable for functional decline during hospital stay and this decline can persist 6 to 18 months after discharge from hospital.Exercise interventions are proven to have effect on mobility, balance and falls among community-dwelling older people and several studies have shown that deconditioning as a consequence of disuse is reversible with training even in very old individuals. However, few studies have evaluated the effects of physical activity promotion and exercise intervention among elderly recently discharge from a geriatric outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* home-dwelling patients who were admitted at the geriatric clinic.
* Assessed by a doctor to tolerate training
* Able to walk in the corridor for 3 min with or without assistive device

Exclusion Criteria:

* Cognitive disorders mini mental status \< 24
Use of Vibration Anesthesia Device in Intratympanic Injections

SUMMARY Intratympanic injections commonly cause pain in the patients. Intratympanic steroid injection (ITS) application can be performed by direct injection without anesthesia or with local anesthesia induced by lidocaine spray, lidocaine injection, topical phenol, pantocaine, EMLA cream (lidocaine+prilocaine) or vibration anesthesia device (VAD). The advantage of VAD application over other anesthetic agents was that it eliminated the need to use local anesthetics that may disrupt wound healing. In addition, inducing anesthesia with VAD can be considered as an alternative method in patients allergic to drugs.

ABSTRACT In this study, we aimed to compare the efficacy of four methods including topical lidocaine spray, local anesthetic cream, vibration anesthesia device (VAD), and saline drops (control group) in the reduction of pain after intratympanic steroid injections (ITS's) and to demonstrate the effectiveness of VAD use. The prospective study included 40 patients aged 18-70 years with idiopathic sudden sensorineural hearing loss. Prior to each ITS, all the four methods including local anesthetic cream (EMLA® cream, AstraZeneca PLC), lidocaine spray (Vemcain® Spray), VAD (Blaine®, Blaine Labs, Santa Fe, USA), and saline drops (control) were administered in each patient. After each ITS, pain assessment was performed using Visual Analogue Scale (VAS), Numerical Rating Scales (NRS), and Verbal Rating Scales (VRS).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-70 years with idiopathic sudden sensorineural hearing loss

Exclusion Criteria:

* History of otologic surgery,
* Recent ototoxic drug use,
* Congenital inner ear malformation,
* History of chemoradiotherapy due to malignant neoplasia,
* Presence of acute or chronic otitis media,
* Age under 18 years, over 70 years
* History of local anesthesia allergy,
* Coagulation abnormality,
* Pregnant and lactating women,
* Hearing cases with other neurootological diseases
Neonatal Package Study in Rural District of Pakistan

Neonatal mortality has been a notable health issue in Pakistan. Considering the importance of the issue and well recognized interventions the investigators are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, Kangaroo Mother Care (KMC) and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and essential neonatal care alone. The investigators anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

The global neonatal mortality burden is one of the imminent factors which derail the achievement of the MDG 4 in many developing countries including Pakistan. Four million infants infants die in their first 28 days of their lives which account for about 40% of the total under-five mortality. The burden of neonatal mortality in Pakistan is alarming as the current neonatal mortality rate (NMR) is 55 per 1000 live births, third worst in the world. The major causes of these deaths are infections, preterm births and birth asphyxia which are avoidable. Despite many initiatives the NMR remains unchanged since last decade in Pakistan.

Literature shows that low cost facility and community based interventions can reduce NMR significantly. Early neonatal care, application of chlorhexidine for cord care and Kangaroo Mother Care (KMC) have been recognized as effective intervention in reduction of neonatal morbidity and subsequently neonatal mortality in many developing countries. However these interventions have never been tested as a package and data about their combined effect is scarce both in Pakistan and developing countries.

Considering the importance of the issue and well recognized interventions we are proposing a randomized controlled trial in a rural district of Pakistan which will evaluate the effectiveness of a neonatal package comprised of the standard neonatal care, KMC and application of chlorhexidine compared with standard neonatal care coupled with application of chlorhexidine and standard neonatal care alone. We anticipate that this study will provide an evidence base way forward benefiting the children of Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* All healthy newborns born in the study settings will be systematically enrolled in the trial after prior consent.

Exclusion Criteria:

* Infants with congenital/birth defects,
* any localized infection on the peri umbilical region at the time of birth or application of
* any other material such as dung etc before enrollment on the cord.
Comapre Effects Of Proprioceptive Training And Core Instability Strength Training In Knee Osteoarthritis Patients

This study aims to determine the influence of core instability exercises in comparison to proprioceptive training in relieving pain, improving balance and physical function in general population of knee Osteoarthritis. The objective is to achieve beneficial results of interventions which can be used in betterment of treatment plan.

A randomized control trial will be held at Safi hospital Faisalabad after the approval of the synopsis. The study will be double blinded clinical trial. Simple lottery method will be practiced to allocate subjects into two groups. Subjects are selected according to there explained inclusion exclusion criteria. The two groups are differentiated as control group and experimental group. Both the groups will be given the baseline intervention including TENS and Infrared. Along with baseline treatment control group will be given proprioceptive training and experimental group will be given core instability exercises. The evaluation is done before the research begin, after 6 weeks, after 12th week and Follow up on 16th week at the end of therapy. The outcomes will be assessed through Visual Analog Scale, Western Ontario and McMaster Universities Arthritis Index and Fullerton Advanced Balance scale. The data will be recorded pre and post treatment and compared after 12th week. Informed consent should be signed by each patient and analysis is done by Statistical Package of Social Sciences Version 21.

Eligibility Criteria:
Inclusion Criteria:

* Knee Osteoarthritis disease
* Kellgren Lawrence stage 1 to stage 4
* Unilateral or Bilateral Knee Osteoarthritis
* Patient who are willing to participate

Exclusion Criteria:

* History of any neurological condition e.g. Parkinson or vertigo.
* History of any past surgical procedure related to lower extremity.
* History of any chronic disease (hepatic, cardiac or renal diseases) which can affect the exercise training.
* History of severe orthopedic issues like fractures which may interfere in treatment sessions.
Once-daily Simultaneous Modulated Accelerated Thoracic Radiotherapy in Limited Small-cell Lung Cancer

This Phase II randomized study is to determine whether once-daily simultaneous modulated accelerated thoracic radiotherapy (RT) resulted in better survival than twice-daily RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

This Phase II randomized study is to determine whether once-daily (qd)simultaneous modulated accelerated thoracic radiotherapy resulted in better survival than twice-daily(bid) RT for patients with limited-stage small-cell lung cancer (LD-SCLC).

All patients receive four to six cycles of etoposide and cisplatin (EP) every 3 weeks. Thoracic RT is initiated with cycle 1-3 of chemotherapy. Qd RT includes the delivery of 65 Gy in 26 fractions delivered on weekdays for a total of 33 days. Bid RT includes the delivery of 45 Gy in 30 fractions delivered on weekdays for a total of 19 days. After the chest RT and the last cycle of EP, prophylactic cranial irradiation is administered to those patients with a complete or partial remission.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of SCLC. Imaging studies' confirmation of limited stage.
* No previous chest radiotherapy, chemotherapy or biotherapy.
* Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
* White blood cell count ≥4×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L; serum creatinine and total bilirubin 1.5 times or less the upper limits of normal (ULN), aspartate aminotransferase two times or less the ULN.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Weight loss ≤10% within the past 3 months.
* Forced expiratory volume in 1 s \>1 L.

Exclusion Criteria:

* Previous or recent another malignancy.
* A myocardial infarction within 6 months or had uncontrolled congestive heart failure, uncontrolled arrhythmia.
* Malignant pleural or pericardial effusion.
* Pregnant or Lactating.
* Weight loss \>10% within the past 3 months.
* Drug addiction, long-term alcohol abuse and AIDS patients.