cyrilzakka/clinical-trials huggingface dataset:
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia

This study is planned as a prospective multicenter NIS. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy will be included into the study across seven Russian districts.

Patients will attend the sites in accordance with routine clinical practice. It is assumed that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement. Available data from routine clinical management of the patients will be collected at patients' visits to the clinical site. Patients enrolled in the study will be followed up until death or study close whichever occurs first. The recruitment period is planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. Patients may discontinue from this NIS at any time.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the moment of ribociclib, alpelisib, monoET or CT treatment initiation.
2. Female gender.
3. Confirmed diagnosis of locally advanced/metastatic not amenable to surgery HR+/HER2- BC (progressed following prior therapy or de novo) for whom the treating physicial took the decision to initiate treatment with ribociclib, alpelisib, monoET or CT before entering the study.
4. Patient who initiated treatment with ribociclib, alpelisib, monoET or CT no longer than 4 weeks (28 days) prior to written informed consent for this study.
5. Patients with ECOG performance status ≤ 2.
6. Provision of written informed consent.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months at the time of aBC diagnosis per the investigator's judgment.
2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated trial or NIS can be included as long as their standard of care is not altered by the study).
3. Patients receiving active treatment for malignancies other than BC at the time of enrollment.
4. Patients who are unable to understand the nature of the study.
Efficacy Of Minimally Invasive Approach In The Surgical Treatment Of Complex Perianal Fistula

The goal of this clinical trial is to study whether the minimally invasive approach in the mucosal advancement flap technique for the treatment of complex perianal fistula improves the healing rate compared to non-minimally invasive surgery.

The main question it aims to answer is:

- Does the healing rate of patients undergoing minimally invasive approach in the mucosal advancement flap technique improve compared to patients undergoing non-minimally invasive surgery?

Researchers will also compare minimally invasive approach in the mucosal advancement flap technique to the non-minimally invasive approach in terms of postoperative pain, fecal incontinence and healing time.

Quality of life and global morbidity will also be analyzed.

Participants will:

* Undergo surgical treatment of complex perianal fistula performed by mucosal advancement flap performed by a minimally invasive technique.
* Attend control visits and fill in symptom forms one week, one month, three months and six months after the surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18.
* Present with a complex perianal fistula not surgically treated with curative intention.
* Present only one main fistulous tract.
* Mucosal advancement flap as the chosen technique for the treatment of the fistula.
* Patient has given informed consent to participate in the study.

Exclusion Criteria:

* Non-cryptoglandular internal fistulous orifice (IFO).
* Extrasphincteric fistula.
* Coexistence of anal fissure.
* Coexistence of hemorrhoids tributary to surgery.
* Coexistence of anal or rectal prolapse.
* Coexistence of inflammatory bowel disease.
* Coexistence of anal or colorrectal cancer.
Prevalence of Facial Asymmetry Among Orthodontic Patients

To estimate the prevalence of facial asymmetry

The objectives of the present study are:

* To estimate the prevalence of facial asymmetry among Egyptian population, according to type, sex, and age.
* To provide an insight into the key aspects to be taken into consideration while accomplishing an accurate diagnosis and formulation of rational integrated orthodontic-surgical treatment plan that considers correction of all aspects of the asymmetry.

Eligibility Criteria:
Inclusion Criteria:

* between 18-40 years old of both sexes who asked for orthodontic treatment

Exclusion Criteria:

* • No previous orthodontic treatment.

  * photographs of poor quality.
  * Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis.
  * Any disease of the jaw that might have affected the normal growth of permanent dentition.
Macrophage Migration Inhibitory Factor for Diagnosing Endometriosis and Its Severity

Endometriosis is a chronic disease affecting women of reproductive age. Macrophage migration inhibitory factor (MIF) is one of non-invasive blood biomarker that was detected in sera of endometriotic patients.The aim of this study was to evaluate the value of serum macrophage migration inhibitory factor in diagnosing endometriosis in women with infertility and chronic pelvic pain and correlate its level with the stage of the disease. Three hundred patient candidate for diagnostic laparoscopy were included in a case-control observational study

observational case-control study conducted in Fayoum University hospital from March 2016 till September 2018. Three hundred women candidate for diagnostic laparoscopy for either infertility or gynecologic chronic pelvic pain were included. The study group included patients with diagnostic criteria of endometriosis. The control group included other causes of infertility or pelvic pain.

Eligibility Criteria:
Inclusion Criteria:

* postmenstrual women
* in childbearing period,
* presenting with either gynecologic chronic pelvic pain (CPP) or infertility
* indicated and fit for diagnostic laparoscopy.
* All women must have no hormonal treatment for the last 3 months and.

Exclusion Criteria:

* Women with bleeding tendency,
* suspicious of gynecologic malignancy or
* active infection
Topical CP-690,550 For Chronic Plaque Psoriasis

Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Having chronic plaque psoriasis for at least 6 months
* Able to withdraw all prior psoriasis treatments
* Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Exclusion Criteria:

* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
* Pregnant or lactating women
* Unwilling to use appropriate contraceptive methods
Study Of Sunitinib In Combination With Cisplatin/Capecitabine Or Oxaliplatin/Capecitabine In Patients With Advanced Gastric Cancer

The purpose of the study is to determine the safe and tolerable doses of sunitinib given together with either cisplatin and capecitabine or oxaliplatin and capecitabine in patients who have advanced gastric cancer who have not received prior chemotherapy for their advanced cancer


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of stomach cancer
* advanced stomach cancer of stage IV
* adequate blood chemistry, blood counts and kidney function
* willing to participate to study requirements and sign an informed consent document

Exclusion Criteria:

* prior chemotherapy for the stomach cancer in its advanced stage
* excessive toxicities related to prior therapies
* pregnant or breastfeeding patients
Distal Rectus Femoris Transfer as a Part of Multilevel Surgery in Children With Spastic Diplegia

The purpose of this study is to evaluate the effects of an additional distal rectus femoris transfer carried out as a part of single-event multilevel surgery in children with spastic diplegic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* cerebral palsy
* spastic diplegia
* ambulatory
* stiff knee gait

Exclusion Criteria:

* relevant previous surgery at the legs
* Botulinum-toxin-injections 6 months prior surgery
Treatment of Low-flow Venous Malformations With Electrosclerotherapy. Prospective Observational Study

Venous malformations (MVs) are congenital abnormalities of the central or periphery caused by developmental errors at different stages of embryogenesis. Histologically they are characterized by large, venous-like vascular spaces. Scleroembolization constitutes the most widespread method in the treatment of venous malformations allowing good results with low invasiveness. Currently, Bleomycin (and its derivatives) is among the most widely used sclerosing agents for slow-flowing vascular malformations (venous and lymphatic malformations) because of the low rate of local serious adverse events such as swelling, necrosis, and nerve injury compared with others.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of low-flow venous malformations eligible for electrosclerotherapy
* Non-indication for embolizing treatment
* Previous treatments are not an exclusion factor, provided that at least 30 days have elapsed.

Exclusion Criteria:

* Previous treatment for \< 30 days
* Pregnancy and lactation status
* Patients of childbearing age without contraceptive use
* Presence of metal synthetic media
* COPD with FiO2 \< 30 mmHg
* Impaired renal function with eGFR\<30 ml/min/1.73mq
* Patients with Bleomycin intolerance or previous episodes of toxicity Bleomycin-related
* Patients who have already received a cumulative dose of Bleomycin ≥100 mg
* Patients who have undergone prior thoracic radiotherapy
* Patients with a history of seizures and epilepsy
ivWatch in Prevention of Extravasation of Vesicants in an Oncology Setting

This study aims to determine the feasibility of using the ivWatch (registered trademark) device to determine if there is an infiltration at the site of a peripheral intravenous (PIV) catheter. An infiltration is when the IV fluid leaks out of a vein and into the surrounding tissue. If medication starts leaking outside the vein, it can cause damage to the surrounding tissue. Using the ivWatch device may identify leaking fluid before the nurse is able to visually observe the signs or symptoms of the leaking fluid.

PRIMARY OBJECTIVE:

I. Evaluate the feasibility of using the ivWatch device to detect extravasations of peripheral vesicants given in an adult oncology ambulatory population.

SECONDARY OBJECTIVE:

I. Evaluate the clinical outcomes of extravasations that occur with the use of the ivWatch device.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring a peripheral IV for infusion of vesicant or vesicant-like agents (chemotherapy, other vesicant medications).
* PIV must be inserted
* Participant (or legal representative) must understand the nature of this study and verbally consent with the Research Study Information Sheet prior to receiving any study related procedure

Exclusion Criteria:

* Patients who are not getting a vesicant, irritant or vesicant like fluid infused.
* Patients who are bruised, scarred, or tattooed in the area of the PIV.
* Patients with skin integrity issues at the site of the PIV.
* Patients who are on "light precautions."
* Not for use in power injectors.
* Not for use on mediports, implanted ports, IVAD, central lines, PICC lines.
* Patients without a cancer diagnosis.
Investigation of the Effect of Mother's Nutrition Status on Breast Milk Contents

This study; this work; The aim is to investigate the effects of mothers' nutritional status on breast milk macro nutrients (carbohydrate, fat and protein).

Macronutrients in breast milk can be affected by various factors. The mothers will be taken in the first 24 hours after birth and their nutritional habits, socio-demographic characteristics, anthropometric characteristics of the mother, body mass index will be examined and newborn characteristics will be taken. 2 ml sample from colostrum will be analyzed with milk analyzer instrument. The mothers will be re-checked on the 5th day and their anthropometric properties will be obtained. The same procedure will be repeated on the 15th day after childbirth. At each control, the mother's last 24-hour feeding status will be taken and the nutritional values consumed by "BeBis" program will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Follow-up of the infant in the Neonatal Intensive Care Unit, Istanbul Faculty of Medicine, Department of Pediatrics,

  * The mother is able to understand and answer the questions,
  * Single pregnancy,
  * The baby's birth week is 34 weeks or more,
  * The mother does not have a disease (Diabetes, hypertension, hypothyroidism, etc.) that may affect breast milk content.

Exclusion Criteria:

* Multiple pregnancy,

  * The birth week of the baby is less than 34 weeks.
  * Breastfeeding or breast problems in the mother,
  * The mother has a disease that may affect breast milk content (Diabetes, hypertension, hypothyroidism, etc.),
  * The mother is not willing to participate in the research,
  * A disease known to be transmitted by breast milk (HIV, hepatitis B, hepatitis C, etc.).
Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

The objective of this study was to investigate whether infants with total serum bilirubin \> 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.

Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age \> 35 weeks
* Total serum bilirubin \> 450 umol/L in the neonatal period
* Born in the period 01.01.2000 - 31.12.2005

Exclusion Criteria:

* Acute intermediate or advanced bilirubin encephalopathy
Protein Ingestion Before Training Low

A randomized interventions study using a crossover design. Ten well trained triathletes or bikeriders will be included for to undergo two trail separated by about 3 weeks. The night before the trail each subject will performe a high intense interval trainings session on an ergometer bike. during the night an infusion of aminoacid tracers will be initiated. The subject is woken at 6.30 a.m. Blood samples and a musclebiopsy will be collected prior to the morning bike ride at 8.00a.m. Immediately before the morning bike ride is started the subject will ingest a drink of 0,5g protein or a non-caloric placebo (random order). During the bike ride and the following 4,5 hours blood will be drawn with regular intervals. at time point 0, 60 and 180 min after the training session biopsies are collected.


Eligibility Criteria:
Inclusion Criteria:

* Healthy well-trained triathletes or cyclists
* VO2max \> 55 ml O2/kg/min
* Training and has been training more than 7 times a week the last 6 months.

Exclusion Criteria:

* VO2max \< 55 ml O2/kg/min
* Has chronic disease
* has incjected with tracer on a previous occasion.
Oxidative Stress Markers in COPD

Background:Striking feature of Chronic obstructive pulmonary disease (COPD) is its inability to resolve after cigarette smoke exposure has ended, which has contributed to the possibility that the disease could also be driven by other endogenous causes, such as autoimmunity or chronic infection . Many of the pathogenetic pathways involved in COPD and its development tend to be driven by oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* 1-Forty subjects of COPD who are non-smokers or stopped smoking for more than 6 months Based on the Global Initiative for Chronic Obstructive Lung Disease guidelines, COPD was diagnosed.9 2- Thirty subjects of non smokers healthy control

Exclusion Criteria:

* Patients of:

  1. Acute exacerbation, at the time of the study, of COPD.
  2. Any obvious abnormal lung parenchymal lesions.
  3. Lung cancer.
  4. Congestive heart failure.
  5. current smokers
  6. Drugs e.g anti-inflammatory , steroids ,analgesics, insulin , antineoplastic, antipsychotic drugs in the previous 2 weeks before the study.
Food as Medicine Study

The purpose of this study is to demonstrate proof of concept that registered dietitian nutritionists (RDNs) can implement a Food as Medicine program that utilizes a grocery E-commerce platform in a food retail setting, and the process of measuring the outcomes is feasible.

The Academy of Nutrition and Dietetics Data Science Center (DSC) will implement the proposed prospective feasibility study. The study aims to measure change in nutrition problems, eating patterns, food purchasing patterns and health outcomes of participants who have agreed to receive a 6-month RDN-led Food as Medicine intervention program in the food retail setting. The intervention will be provided to all study participants and change will be evaluated in participants by comparing data at baseline and endline. The Food as Medicine intervention program will consist of:

* Personalized nutrition counseling (delivered in-person or telehealth, depending on preferences of the participant) by Hy-Vee RDNs.
* Personalized meal plans (based on program participants' individual anthropometrics, disease state, health goals, culture, food allergies / intolerances and eating preferences). The meal plans will be generated by the nutrition technology software, NutriStyle.
* Personalized shopping lists generated by a nutrition technology software (NutriStyle) and utilized for in-store grocery shopping, online grocery pick-up or online grocery delivery.

Eligibility Criteria:
Inclusion Criteria:

1. 18+ years old
2. Household/participant willing to utilize the shopping list provided
3. No new medical diagnoses or medications (unrelated to the study intervention) within the last 3 months and no anticipated changes during the intervention period. (The participant may have a new medical diagnosis for which they are seeking MNT.)
4. Nebraska or Iowa resident
5. Minimum of one new self-reported diagnosis or an existing diagnosis that participant has not sought MNT for previously: Overweight/obesity, Hypertension, Cardiovascular disease, Pre-diabetes, Type 2 diabetes
6. First visit with the RDN for the current medical diagnosis (may have received MNT for other conditions previously)
7. Access to Hy-Vee Aisles Online and NutriStyle, through the computer or mobile app
8. Willing to use Hy-Vee's Aisles Online e-commerce platform and NutriStyle
9. Willing to meet with a Hy-Vee RDN regularly in person or via telehealth (and talk on the phone with the Hy-Vee RDN monthly) throughout the study intervention (6 months)
10. Current Hy-Vee fuel saver card holder, or willing to obtain a fuel saver card
11. Provide verbal and written communication and written informed consent in English

Exclusion Criteria:

1. Prescribed or taking over-the-counter weight loss medication at enrollment
2. Prescribed corticosteroids or other drug known to interfere with glucose metabolism
3. Scheduled for bariatric weight loss surgery during 6-month study intervention period
4. Pregnant/lactating
5. Currently working with another nutrition care professional
Potential Benefits of Expanded Hemodialysis in Prevention of Sarcopenia

The current study will investigate whether long term implementation of expanded hemodialysis (HDx) will effectively decrease serum levels of large uremic toxins and ameliorate progression of sarcopenia in patients with chronic kidney disease requiring hemodialysis.

This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the efficacy of expanded hemodialysis (HDx) compared to conventional hemodialysis in patients with chronic kidney disease in South Korea for up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* On HD treatment over 6 months before study enrollment
* Aged over 18 years
* Able to give informed consent

Exclusion Criteria:

1. Hemiplegia or paraplegia state
2. Planned renal transplant or conversion to peritoneal dialysis within study period
3. Active chronic infection or inflammatory conditions including autoimmune disease, inflammatory arthritis and active malignancy
4. History of monoclonal gammopathy
5. Life expectancy \<12 months
6. Pregnancy or breast feeding
7. Receiving immunosuppressant medication
8. Inability to complete study assessments
Phase II Clinical Study of Imatinib Mesylate in Patients With Malignant Gastrointestinal Stromal Tumors (Extension Study)

This is a extension study of CSTI571B1201 study


Eligibility Criteria:
Inclusion Criteria:

- Patients who completed the CSTI571B1201 study

Exclusion Criteria:

-

Other protocol-defined inclusion / exclusion criteria may apply.
Screening of TMA Patients für ADAMTS13 Activity (Adamscreen)

Screening of TMA patients for ADAMTS13 activity and the description of systemic organ damage and/or organ failure in different entities of thrombotic microangiopathies (TMA)

This is a prospective diagnostic analysis enrolling 100 patients with clinically suspected thrombotic microangiopathy (TMA) on the basis of laboratory findings such as thrombocytopenia, Coombs negative haemolytic anemia with increased LDH and increased schistozytes. As a first step of differential diagnosis, patients are classified by determining ADAMTS13 activity and antigen concentration and also analyzing for Shigatoxin and Shigatoxin producing bacteria respectively. Primary objective is to determine the relative incidences of the three major entities i.e. aHUS, STEC-HUS and TTP considering distribution of age and gender as well. Mean value of ADAMTS13 activity and antigen measured at date of first diagnosis is considered to line out a threshold value for ADAMTS13 activity pronouncing clinical apparent TMA. Furthermore the present study intends to characterize clinical presentation, clinical course and outcome of different TMA forms particularly with regard to treatment procedures. Monitoring of how ADAMTS13 activity and antigen changes in the course of the disease and in response to treatment is of particular concern for this study. Family history and special clinical conditions should be noted identifying potential genetic predisposition and definite clinical triggers leading to disease manifestation.

Eligibility Criteria:
Inclusion Criteria:

-Patients with first history of TMA as patients with recurrent TMA or TMA in complete or partial remission are eligible for analysis

Exclusion Criteria:

-Patients who received plasma intervention more than 3 weeks prior to screening must be excluded from the observational study