cyrilzakka/clinical-trials huggingface dataset:
How Breast Conservative Surgery (BCS) Affects Women's Daily Activities On Post-Operation 2 Days?

we revise 8 disability items from SPADI into Chinese to develop a simple self-completion questionnaire for the assessment of restriction in daily activities resulting from breast conservative surgery.

The purpose of this study was to validate the score obtained from this questionnaire by testing restriction of shoulder active flexion and abduction on examination at post BCS 2 days correlates with disability score.

Breast-conserving therapy (BCT) is a breast cancer treatment using breast conservative surgery(BCS) with lymph node dissection and with or without following by radiotherapy(RT). (Morrow,2004). Results of BCTs demonstrate high rates of local tumor control with satisfactory cosmetic results. (Morrow,2004) Nowadays, the local treatment of breast cancer has slowly accepted from radical mastectomy with lymph node dissection to (BCT) in the last 100 years. (Morrow,2004) After surgical intervention for breast cancer carcinoma, the most frequent morbilities are lymphedema of the unilateral upper extremity and shoulder dysfunction. (Wingate L,1985; Grube, 2004)From the perspective of the Institute of Medicine's(IOM), the outcome measures shifts from the impairment-based measures to functional limitation measures. (Jette AM,1995) Base on the third element in Donabedian's framework of quality of physical therapy care, the determination of outcomes in terms of death, morbidity, disability, or quality of life. (Jette AM,1995)Although shoulder active range-of-motion exercises could start at the day right after any type or level of lymph node dissections for breast cancer patients, (Staradub VL, 2004;Wingate L,1985) in my literature review results, no functional evaluation questionnaires that was sensitive enough to detect the disabilities resulting from lymph node dissections at post BCS 2 days. So we revise 8 disability items from SPADI into Chinese to develop a simple self-completion questionnaire for the assessment of restriction in daily activities resulting from breast conservative surgery.

The purpose of this study was to validate the score obtained from this questionnaire by testing restriction of shoulder active flexion and abduction on examination at post BCS 2 days correlates with disability score.

Eligibility Criteria:
Inclusion Criteria:

* post breast conservative surgery 2 days
* with lymph node dissection

Exclusion Criteria:

* total SPADI score is not zero
Radial, Sequential Compression Device Deep Venous Thrombosis Detection Study

The purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. The investigators aim to show that this new compression device is no worse than the standard sequential compression device (SCD) at preventing DVT and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. This new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.

Compression therapy of the leg is a proven and well-established modality to prevent deep vein thrombosis in immobilized and post-surgical patients. The investigators aim to compare a new sequential compression for the leg that utilizes a servo motor for compression as opposed to a traditional pneumatic motor that is typically used in the hospital and after surgery. Pneumatic sequential compression devices are cumbersome, expensive and not mobile. This new compression device was developed to provide a cheaper, mobile device that can be worn by the patient after surgery and while at home during ambulation. The addition of the servo motor and fine sensors may also be able to detect sub-clinical DVT's that contribute to post-surgical pulmonary embolus and post-surgical complications. The investigators aim to learn how this new device performs in the subset of patients undergoing complex spine surgery, the incidence of post-surgical DVT with this new device compared to traditional SCD and if this new device is capable of detecting sub-clinical post-surgical DVT.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for complex spine surgery at Stanford Hospital

Exclusion Criteria:

* Pregnancy
* Non-decisional capacity
* Incarcerated persons
* Any hereditary or acquired coagulopathy
Nebulized Bupivacaine Analgesia for Cleft Palate Repair

In this study we introduce a potent local anesthetic; bupivacaine 0.5% in two different doses by nebulization as a preemptive analgesia to compare efficacy and safety in children with cleft palate repair.

A written informed consent will be taken from the guardian of children. Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive; Nebulized Bupivacaine 0.50% 0.25 mg.kg-1 (Group B1) or Nebulized Bupivacaine 0.50% 0.50 mg.kg-1 (Group B2) or same volume of saline placebo (Group C).

Eligibility Criteria:
Inclusion Criteria:

* Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
* Elective cleft palate repair ± cleft lip surgery under general anesthesia .

Exclusion Criteria:

* Coronary artery disease
* Hypertension
* Developmental delay
* Allergy to study drug
Outcomes of Children After Hospitalization in Intensive Care Unit

More than 10,000 children are hospitalized in an PICU every year in Canada. While most of them will survive their PICU hospitalization and their critical illness, some children will not recover to their pre-illness level. Some may develop behavioral, physical, emotional or developmental problems and difficulties at school. All these problems are elements that are part of the Pediatric Post-Intensive Care Syndrome (PICS-p).

It is important to understand the elements (risk factors) that play a role in the development of PICS-p. In Canada, there is no systematic follow-up for children after they leave the PICU. Understanding what can cause PICS-p (risk factors) and how much PICS-p has an impact on children and their family is very important to the family well-being.

The Pediatric Post-Intensive Care Syndrome (PICS-p) is a newly developed conceptual framework that incorporates the constellation of morbidities that are increasingly recognized to affect children and their families after a critical illness. Experts define PICS-p as a new or worsening impairment in any of the following 5 domains of child health: physical, cognitive, emotional, social, or family.

In contrast to well established follow-up programs in adults, there is currently a lack of systematic follow-up of PICU survivors which prevents both the recognition and management of PICS-p. The absence of granular, empirical data on the recovery of PICU children impedes both the identification and management of PICS-p.

This project is a prospective Canadian multicenter cohort study to identify risk factors of PICS-p, develop and validate a predictive model for PICS-p to detect at-risk children, characterize each domain of PICS-p over two years post critical illness and uncover additional morbidities that are not captured using the current PICS-p framework. This study will provide granular, empirical data on which to build developmentally appropriate and tailored screening, management, and intervention programs during and after PICU to improve the global recovery of critically ill children and their family.

Eligibility Criteria:
Inclusion Criteria:

* Children ≤18yo hospitalized in PICU for ≥96 hours

Exclusion Criteria:

1. gestational age \<37 weeks or age \>18 years at PICU entry;
2. admitted for congenital heart surgery (followed in neuro-cardiac clinics in most centers);
3. anticipated life expectancy \<1year (e.g., active do not resuscitate status).
Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

RATIONAL: Simmitecan is an anticancer ester prodrug, which involves activation to chimmitecan. Chimmitecan，a novel CPT derivative, exhibited potent antitumor activities both in vitro and in vivo by inhibiting topoisomerase I. Also exerted comparable effects on topoisomerase I compared with topotecan and SN38 and possessed improved anticancer potency and pharmacologic profiles, compared with the clinically available CPT analogues.

PURPOSE: to determine the maximum tolerated dose, the safety profile and pharmacokinetics of Simmitecan.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory to standard therapy or no standard therapy available.
* At least one measurable lesion.
* Age = 18\~65 years.
* ECOG=0-1.
* Life expectancy ≥ 12 weeks.
* More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors.
* Adequate organ function:

Haemoglobin ≥ 100 g/L, Absolute neutrophil count \[ANC\] ≥ 2×109/L,Platelets ≥ 100 × 109/L), Serum bilirubin ≤ 1.0×ULN, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 1.5×ULN (If liver metastases, serum transaminase ≤ 2.5×ULN), Creatinine clearance ≥ 50 mL/min , LVEF ≤ 50%, QT interval (corrected by Fridericia): male \< 450 ms, female \< 470 ms

* Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
* Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

* Less than 4 weeks from the last clinical trial.
* Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening.
* Patients had ever severe diarrhea with prior therapy of camptothecin drugs.
* Concurrent severe or uncontrolled medical disease (serious infection, serious diabetes)
* Significant cardiovascular disease or condition including ≥ class II cardiac function (NYHA)
* Acute and chronic viral hepatitis. (If HBsAg +, HBV-DNA quantification ≤ LLN.)
* Pregnant, lactation period or men/women ready to birth.
* Psychiatric disorder or altered mental status.
* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study
Study to Evaluate CORT125134 in Participants With Cushing's Syndrome

Cushing's syndrome is a relatively rare disorder caused by prolonged exposure to high levels of the glucocorticoid hormone cortisol. Cushing's syndrome may result from elevated endogenous or exogenous sources of cortisol. Endogenous Cushing's syndrome resulting from cortisol overproduction by the adrenal glands is the subject of this protocol.

Patients with exogenous Cushing's syndrome, which develops as a side effect of chronic administration of high doses of glucocorticoids, were not eligible for enrollment in this study.

The purpose of this study was to evaluate the safety and efficacy of CORT125134 for treatment of endogenous Cushing's syndrome. The multicenter study was conducted in the United States and in Europe.

This was a Phase 2, open-label study with two dose groups, each with a two-step dose escalation, designed to evaluate the safety and efficacy of CORT125134 for the treatment of endogenous Cushing's syndrome. CORT125134 was administered orally once daily for 16 weeks with dose escalations occurring every 4 weeks.

Pharmacokinetics (PK) profiles were generated at every dose level. A data review committee reviewed PK and safety data and recommended the final plan for dose escalation in Group 2.

Eligibility Criteria:
Inclusion Criteria:

1. Has a confirmed diagnosis of endogenous Cushing's syndrome.
2. Requires medical treatment of hypercortisolemia.
3. Meets at least one of the following criteria:

   1. Has type 2 diabetes mellitus.
   2. Has impaired glucose tolerance.
   3. Has hypertension.

Exclusion Criteria:

1. Has non-endogenous source of hypercortisolemia
2. Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism
3. Has poorly controlled hypertension
4. Has Stage ≥ 4 renal failure
Biomarkers of Broccoli Intake: A Pilot Study

The objectives of the study are 1) to characterize plasma and urinary metabolites that originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and 4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2) to identify novel plasma and urinary metabolites following broccoli consumption that may have roles in reducing the risk of cancer.

Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Breakdown products of indole glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have received comparatively less research attention than those of aliphatic glucosinolates. The aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.

Eligibility Criteria:
Inclusion Criteria:

* Non tobacco user
* Cancer Free
* Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion Criteria:

* Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
* Pregnant, lactating, or intending to become pregnant during the study period
* Crohn's disease or diverticulitis
* Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

Patients with acute back pain (\<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.


Eligibility Criteria:
Inclusion Criteria:

* acute (\<6 weeks) back pain
* \>20 und \<60 years of age
* good oral and written knowledge of German language

Exclusion Criteria:

* any treatment for back pain within the last 6 months
* Cauda equina
* tumor
* generalized pain
* severe systemic illness
* substance abuse
* pregnancy
Effect of Standardized Lacrimal Sac Massage Compared With Probing for Congenital Lacrimal Duct Obstruction

Congenital nasolacrimal duct obstruction (CNLDO) is a common ophthalmic condition in children, presenting with tearing and pus overflow, with a prevalence of 5%-20% within 1 year of age. Although most cases resolve spontaneously within 1 year of age, some children require treatment. Lacrimal sac massage is a non-invasive, easy and cost-effective conservative treatment that helps to unblock the obstruction by increasing the pressure in the tear duct. Studies have shown that massage has a 93% cure rate in children under 8 months of age. In contrast, tear duct probing is effective but invasive and risky. In recent years, with the development of minimally invasive techniques, lacrimal sac massage has received renewed attention, and studies have shown its efficacy to be comparable to probing. However, there are problems of non-standardized massage timing and techniques in clinical practice, which affects the therapeutic efficacy. This study aims to assess whether the efficacy of standardized dacryocystic massage is not inferior to that of dacryocystorhinostomy through a randomized controlled trial, providing a reference for the treatment of CNLDO.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 3 months to 1 year;
2. Presence of at least one symptom of CNLDO (tear spillage, mucous discharge) in one or both eyes;
3. No surgical treatment for NLD (probing, balloon dilation, tube placement, DCR, etc.);
4. Can cooperate with the examination and subsequent follow-up;
5. Guardians agreed to be enrolled in the study and signed an informed consent form.

Exclusion Criteria:

1. Combination of presenting infections of the conjunctiva and cornea;
2. Combination of other serious ocular surface and intraocular disorders that may affect the therapeutic effect;
3. Congenital malformation syndromes, developmental delays, facial anomalies, facial deformities; history of surgery or injury to the lacrimal duct, history of punctal occlusion, history of lacrimal fistula, history of congenital bulging of the lacrimal sac, history of acute dacryocystitis, history of severe blepharitis, and perinatal abnormalities such as preterm labor, low birth weight, and so on;
Testing Product Messages for Colombia

Purpose: To better understand the impact of different front-of-package labels (FOPLs) on consumer purchasing intentions and ability to identify unhealthy foods.

Participants: \~8,000 Colombians, recruited from Offerwise, that are 18 years or older.

Procedures (methods): Participants will be randomly assigned to view images of food and drink products with either a nutrient warning label, Guideline Daily Amount label, Nutriscore label, or no-label control. They will be asked a series of questions about the products and the labels (excluding control group) on them. Questions will also include standard demographic and health related variables.

Participants will be recruited from Offerwise (an online panel research company). Following online consent, participants will be randomly assigned to view different labels (explained below) on food and drink packaging. Participants will answer self-reported responses to the content (e.g., elaboration, beliefs, perceived healthfulness). After being randomized to one of the four groups and answering questions (e.g. which product is healthier, which product would you buy), the participant will see all three labels and select which is most dissuading from consuming a product high in a nutrient. At the end, the participant will answer demographic questions.

Participants will be randomized to see either a no-label control or 1 of 3 nutrient labels. The participants will see 5 types of products with the labels (fruit drinks, yogurt, sliced bread, cookies, and breakfast cereal).

Nutrient labels:

1. Guideline Daily Amount label
2. Nutriscore label
3. Adapted Peruvian nutrient warning label (high in sugar, high in saturated fat, high in salt/sodium)

Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* Resident of Colombia
* Offerwise panel member (recruitment platform)

Exclusion Criteria:

* \<18 years old or \>64 years old
* Not a resident of Colombia
Referred Pain Patterns Infraspinatus Muscle

The first aim of the study will be to identify the most common ReP pattern and compare its coincidence with that described by Travell and Simons. Second, the study aim will be to verify whether there are any significant differences by sex and types of technique used in regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more sensitive.Finally, the third aim of the study will be to determine whether deep dry needling will evoke the LTR and ReP more easily than manual palpation.

Patients will be recruited from a university's employee and student population by advertising at the university. Patients with shoulder complaints (described as pain felt in the shoulder or upper arm) will be randomly assigned to either an manual palpation or deep dry needling group. Participants will be randomly divided into 2 groups, a deep dry needling group and manual palpation group. Visual analogue scale (VAS), referred pain (ReP) pattern and features of referred pain of the infraspinatus muscle will be all assessed post-technique.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years.
* To remain seated or in front of data visualization screens (tablets, computers or smartphones) for at least 4 hours a day.
* Shoulder complaints in the last six weeks.

Exclusion Criteria:

* Patients with evidence of serious medical illness.
* Cognitive impairment.
* Psychosocial disorders.
* Bilateral affectation of shoulder pain.
* Pregnancy.
The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants

The purpose of the study is to investigate the effect of treatment of traumatized refugees with a diagnosis of Post-Traumatic Stress Disorder (PTSD). The existing evidence point towards antidepressants of the type SSRI and trauma-focused cognitive Behavioural Therapy being the most effective treatments of PTSD, but very little evidence of treatment effects exist for the group of multitraumatized refugees. This study therefore seeks to investigate the treatment effect of 6 months drug therapy with antidepressants (Sertraline and/ or Mianserine) and/or trauma-focused cognitive behavioral therapy. A total of 200 individual will undergo treatment. They will be randomized to 4 different groups: antidepressants, psychotherapy, a combination og drug and psychotherapy and a waiting list. Outcome measures include symptoms, life quality and function. Patients with a diagnosis of drug abuse or psychosis will not be included. The hypothesis is that a combination of antidepressants and psychotherapy will be more effective than either of the two treatment regimes on their own.


Eligibility Criteria:
Inclusion Criteria:

* Adult traumatised refugee with PTSD

Exclusion Criteria:

* psychosis and drug abuse