cyrilzakka/clinical-trials huggingface dataset:
Risk Factors for Fall and Fracture

This project aims to improve the global outcome for an aging individual after a traumatic fall, through identifying conditions contributing to a fall and promoting recovery and rehabilitation. Through better understanding 'falling phenotype', the ultimate aim is to prevent future complications, as well as new falls and fractures in the growing older population.

Background: The knowledge of risk factors for falls and fractures amongst older individuals are enormous, still identification of fallers and prevention of falls is not part of Swedish standard of care. Some risk factors are more or less overlooked, such as alcohol consumption, orthostatic reactions, as are increased risks related to common medications such as certain antidepressants, opioids and sedatives. Although functional activity and frailty scores have been suggested to be potential predictors of adverse events, length of hospital stay and mortality, the use of standardized questionnaires has not been implemented in routine care in Sweden. Furthermore, outcomes after fragility fractures, a well known consequence of falls among older individuals, are continuously poor, although palpable improvements have been reached regarding surgical treatment. Are there other factors that are equally or more decisive for the global outcome from the patient's point of view?

Material \& Methods: In this prospective observational cohort study, all in-patients treated due to a fall-related trauma (fracture, dislocation or contusion) at the Department of Orthopaedics, Skane University Hospital Malmö, aged 65 years or older will be invited to participate during a 1-year study period. In all participants, a standard package of blood samples, temperature, measurement of orthostatic blood pressure and grip strength, grading of frailty and activity will be routinely obtained.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older at the time of admission.
* Admitted to Orthopaedic ward at due to fall, with or without a fracture.

Exclusion Criteria:

* Younger than 65 years old at the time of admission.
* Severe head trauma or other severe non-orthopaedic trauma.
* Other condition requiring ward at other department (CCU, ICU).
* Moribund individuals with palliative care only.
A Study of LY3321367 Alone or With LY3300054 in Participants With Advanced Relapsed/Refractory Solid Tumors

The purpose of this study is to evaluate the safety of the study drug known as LY3321367, an anti-T-cell immunoglobulin and mucin-domain domain-containing molecule-3 (TIM-3) antibody administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in participants with advanced relapsed/refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* For Ph1a monotherapy and combination cohorts, histologic or cytologic confirmation of advanced solid tumor.
* For Phase 1a and 1b, prior PD-1 or PD-L1 therapy or other immunotherapy is allowed, if the following criteria are met:

  * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
  * Must have completely recovered or recovered to baseline prior to screening from any prior AEs occurring while receiving prior immunotherapy.
* Must have provided tumor tissue sample, as follows:

  * For participants entering Ph1a: have submitted, if available, an archival tumor tissue sample.
  * For participants entering Ph1b: have submitted, a sample from a newly obtained core or excisional biopsy of a tumor lesion or a recent biopsy defined by 6 months of study enrollment (Ph1b).
* Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Must have adequate organ function.
* Have an estimated life expectancy of 12 weeks, in judgement of the investigator.

Exclusion Criteria:

* Have symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids (participants receiving anticonvulsants are eligible).
* Have received a live vaccine within 30 days before the first dose of study treatment.
* If female, is pregnant, breastfeeding, or planning to become pregnant.
* Have a history or current evidence of any condition, therapy, or laboratory abnormality that might interfere with the participant's participation.
* Have moderate or severe cardiovascular disease.
* Have a serious concomitant systemic disorder that would compromise the participant's ability to adhere to the protocol, including active or chronic infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV), active hepatitis C virus (HCV), active autoimmune disorders, or prior documented severe autoimmune or inflammatory disorders requiring immunosuppressive treatment.
* Use of escalating or chronic supraphysiologic doses of corticosteroids or immunosuppressive agents (such as, cyclosporine). \[Use of topical, ophthalmic, inhaled, and intranasal corticosteroids permitted\].
* Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
* Evidence of interstitial lung disease or noninfectious pneumonitis.
Sustaining Women's Smoking Cessation Postpartum

To conduct a five-year demonstration and education project to sustain smoking cessation postpartum by women who had stopped smoking in pregnancy.

BACKGROUND:

The results from this study were expected to demonstrate the effectiveness of a practical program to protect women and their families from direct and indirect smoke exposure and to contribute longitudinal data on change processes involved in smoking cessation, especially those over the maintenance, relapse, and recycling stages, in a relatively complete population through a critical transition.

DESIGN NARRATIVE:

The TLC Program, unique in its focus on the postpartum period, used a researched model of behavior change that matched messages and skill training with the woman's stage of change. It also addressed the whole family to create a supportive environment for individual change, included other steps for families to protect children from passive smoke and negative modeling, and focused on smoking and smoke exposure directly as well as through self-care and child-care messages. The program used innovative materials, including videotapes and intervention.

The study took place in two multi-ethnic health-care sites where the research team had conducted previous studies. The study used a randomized mixed design with 500 women who smoked regularly before pregnancy and who had been abstinent for \> 30 days at their 28th week of pregnancy. The primary outcome was abstinence at one year postpartum. Secondary outcomes were partner smoking status and exposure of the index baby. Self report was validated biochemically in samples of mothers and babies. The study design separated data collection from the experiments by enrolling subjects in a university-sponsored study of new mothers' health-care site.

Eligibility Criteria:
No eligibility criteria
Video Treatment for Amblyopia

The purpose of this study is to determine whether viewing asynchronous movies leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to treatment.

This is a single-site randomized clinical trial to compare treatment of amblyopia by viewing asynchronous movies to standard-of-care occlusion therapy with an adhesive patch. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.

Children will participate in their assigned occlusion therapy at home for 6 weeks (primary outcome). Adherence will be objectively monitored. Vision will be re-assessed at 2 and 4 weeks and all tests will be repeated at 6 weeks. The asynchronous movie group will have an option to continue for and additional 2 or 4 weeks (10 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the movie treatment at the 6 week visit through 10 weeks. Children who choose to remain in the study beyond the 6 week primary outcome visit will have vision reassessed at 8 and 10 weeks.

The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-6 weeks) between the movie group and the standard-of-care patching group. Secondary analyses will include comparisons of adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 weeks and 95% CIs, comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 6 and 10 weeks for the movie group (8 and 10 weeks means and 95% CIs).

Eligibility Criteria:
Inclusion Criteria:

* aged 3-8 years (3-7 primary cohort)
* male and female
* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity 0.3-0.8 logMAR)
* interocular visual acuity difference ≥0.3 logMAR
* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
* child's ophthalmologist and family willing to forgo standard patching treatment during the study

Exclusion Criteria:

* prematurity ≥8 wk
* coexisting ocular or systemic disease
* developmental delay
* strabismus \>5 pd
* myopia \> -3.00D
The Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery

The goal of this clinical trials to study and compare the effects of "desflurane with remifentanil anesthesia (study group)" and "sevoflurane with remifentanil anesthesia (control group)" for elective fundus surgery anesthesia. The main question it aims to answer are the characteristics of desflurane anesthesia in patients undergoing fundus surgery and to provide universal guidance for clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. ASA I-II, patients aged 18-65 years old;
2. Fundus surgery to be performed under general anesthesia ;
3. The expected duration of surgery is about 30-120 min ;
4. BMI: 18-30 kg/m2 ;
5. Those who signed the informed consent form and volunteered to participate in this trial

Exclusion Criteria:

1. Patients with known or suspected genetic susceptibility to malignant hyperthermia;
2. Patients with history of asthma;
3. Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
4. Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
5. Patients with history of psychotropic drug abuse within 3 months;
6. Patients with long-term alcohol abuse;
7. People with mental disorder and unable to communicate normally;
GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
* Willing to give informed consent for participating in this study

Exclusion Criteria:

* Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed \& recorded in case record form.
* Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
* Exclusion criteria should be read in conjunction with local product information
Effectiveness of Cohesive Bandage on Axillary Web Syndrome After

Objective: To determine the effectiveness of cohesive bandage on the axillary web syndrome in improving pain, reducing swelling and increasing mobility and functionality of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 and 6 months post-intervention post-intervention. Participants: 90 consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Control group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active arm therapeutic exercises; Intervention group: progressive active arm therapeutic exercises with cohesive bandage.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral breast cancer;
* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
* Axillary web syndrome in upper limb of the operated side;
* Consent to participate in the study;
* No contraindications.

Exclusion Criteria:

* Cognitive impairment;
* Visual impairment for reading;
* Lymphedema;
* Bilateral breast cancer;
* Systemic disease (metastases),
* Infection;
* Locoregional recurrence.
Effects of Sub-Occipital Myofascial Release in Patients With Cervicogenic Headache

Cervicogenic headache is a secondary form of headache that occurs from the upper cervical spine and atlanto-occipital joint. A CGH is a frequent source of chronic headache and is frequently misdiagnosed .Cervicogenic headache is among the most common problem affecting four times more women as compared to males and is considered by some painful feeling in the head , neck ,temporal area, frontal area and around the eyes areas.

There is also pain in the face and ipsilateral head that does not alternate the sides, but when cervicogenic headache becomes severe, in some patients pain may occasionally feel it on the other side of the head. Diagnosis of cervicogenic headache depends on the detailed patient's history, manual examination and the assessment of nervous system. After the diagnostic block test disappearance of headache shows that the source of this pain is cervical spine. Cervical flexion rotation test is a very useful diagnostic measure in cervical movement restriction and differential diagnosis of cervicogenic headache. Physical therapy is considered most effective treatment of cervicogenic headache in which different techniques manipulative therapy, mobilization of cervical vertebrae, stretches and sub-occipital myofascial release used.

Objective: To determine the effects of sub-occipital myofascial release in patients with cervicogenic headache.

Methods: This study was randomized control trial and on the basis of inclusion criteria, 22 patients were included and were randomized through sealed envelope in two groups A and B. Group A was given sub-occipital myofascial release along with conventional therapy while group B was given cervical mobilization and conventional therapy and both groups were assessed by using Neck Disability Index(NDI), Pain Numerical Rating Scale(PNRS) and cervical range of motion by goniometer at baseline, Week(1-4) and 8th week( last week) .The data was analyzed using SPSS 21.

Eligibility Criteria:
Inclusion Criteria:

* • Both Genders

  * Age between 20 to 75 Years
  * Neck pain referring the unilateral pain to the sub-occipital region and head.
  * Headache intensifying upon manual pressure to upper cervical joints and muscles
  * With the cranio-cervical Flexion rotation exam, neck pain and ipsilateral headache and restriction of C1 and C2 rotation.

Exclusion Criteria:

* • Tension headache (Headache on both sides)

  * If the patient not tolerate the cranio-cervical Flexion rotation test.
  * Patients presents with autonomic symptoms like visual disturbance, vertigo, dizziness.
  * If the physiotherapeutic modalities used for head pain in the last 6 months.
  * Headache other than cervical origins.
  * Clinically diagnosed as case of cervical radiculopathy or myelopathy.
  * Extreme cervical discomfort due to disk herniation, stenosis of the spinal canal and cervical arthritis.
  * Each other disorder that may be contraindicated in the upper cervical area of myofascial release.
Carboplatin With or Without Thalidomide in Treating Patients With Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of ovarian cancer by stopping blood flow to the tumor.

PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with thalidomide works compared to carboplatin alone in treating patients with ovarian epithelial cancer.

OBJECTIVES:

* Determine the safety of carboplatin and thalidomide in patients with stage IC-IV ovarian cancer.
* Determine the antiangiogenic effect of thalidomide in this patient population.
* Compare the efficacy of carboplatin with or without thalidomide in this patient population.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive carboplatin IV over 1 hour. Treatment continues every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive carboplatin as in arm I. Patients receive thalidomide orally once daily. Thalidomide treatment continues for up to 24 weeks commencing on the first day of carboplatin therapy and ceasing 4 weeks after the last course of carboplatin.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed stage IC-IV ovarian epithelial cancer
* Post-menopausal OR
* Prior bilateral salpingo-oophorectomy and/or total abdominal hysterectomy

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other concurrent invasive malignancies
* Not pregnant
* No diabetes mellitus
* No chronic neurological disease causing peripheral neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No other concurrent cytotoxic agents

Endocrine therapy:

* Not specified

Radiotherapy:

* Concurrent local radiotherapy for treatment of secondary disease sites allowed

Surgery:

* See Disease Characteristics
Development of Simulated Hippotherapy System and Investigation of Its Effectiveness in Children With Cerebral Palsy

The purpose of this study is to develop a simulated hippotherapy system controlled by electromyography (EMG) signals and investigate its effectiveness in children with cerebral palsy. In order to investigate its effectiveness evaluation of gross motor functions, lower extremity joint movements, spasticity of the lower extremities, functional independence, body movements, sitting and standing balance, muscle tone, stiffness and elasticity level, analysis of the walking are planned.

Hippotherapy is a therapeutic method in which a real horse is used for therapeutic purposes. It is widely used in many countries in the treatment of neuromuscular diseases (Multiple Sclerosis, stroke, Cerebral Palsy, etc.). Although the use of hippotherapy is widespread, many people can not reach and use this method effectively because of many reasons such as the high cost of caring, feeding, and sheltering horses or fear of people from horses. In recent years, hippotherapy simulation devices (mechanic and robotic horses) have been developed to overcome these problems. These devices aim to create the effects of hippotherapy on people by simulating a real horse's movement. The aim of this project is to develop and produce a simulated hippotherapy system, which can be controlled by electromyography (EMG) signals coming from the rider, movements programmable (for different musculoskeletal problems), rehabilitation-specific, providing evaluation during therapy, integrating virtual reality system and therapy games and investigate its effectiveness in children with cerebral palsy.

Eligibility Criteria:
Inclusion Criteria

* Having a diagnosis of Spastic Cerebral Palsy,
* Children aged between 5 - 18 years,
* Gross motor functional level is I, II or III,
* Independent seating
* Walking at least 10 meters independently,
* Can understand simple verbal instructions,
* Those with a spasticity level less than 2 according to Modified Ashworth Scale ,
* Having bilateral hip abduction enough to sit on the hippotherapy device,
* Voluntary acceptance to participate in the study

Exclusion Criteria

* Having hip dislocation,
* Severe contracture or deformity,
* Scoliosis (above 20 degrees),
* Acute uncontrolled acute seizures,
* Epilepsy,
* Visual and auditory problems,
* Injection of botulinum toxin in the last 6 months,
* History of surgical operation such as muscle relaxation, tendon extension and selective dorsal rhizotomy in the last 6 months.
Mastering Hospital Antimicrobial Resistance and Its Spread Into the Community-Healthcare Workers

Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff).

PURPOSE:

To define the carriage of, and risk factors for carriage of resistant organisms among healthcare employees of carriers of resistant bacteria.

To define activities of healthcare employees who likely to lead to dissemination of resistant bacteria in rehabilitation centers.

Detailed activity:

Medical staff will be screened for MRSA and ESBL (including: doctors, nurses, nurse aids, physical therapists, dietitians, Janitors and other medical staff).

Screening will be performed by obtaining nares and perirectal cultures. Nares cultures will be obtained by ward staff or research personnel who are experienced in performing this activity: a moisture swab will be applied gently to the distal part of both nares. Perirectal cultures, will be taken by swab, who will be applied to the perirectal area, either by staff as mentioned above, or will be given to the healthcare workers to perform by himself (with explanation on how to perform it).

Eligibility Criteria:
Inclusion Criteria:

* Health care employees

Exclusion Criteria:

* Age 18 years or less