cyrilzakka/clinical-trials huggingface dataset:
A Randomized Clinical Trial Comparing Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL

The goal of this clinical trial is to compare Chi-BEAM With BEAM Regimen Combined With ASCT for the Treatment of ND PTCL.

The main question it aims to answer are:

•Whether Chi-BEAM improves patient survival compared to BEAM group Participants will be given BEAM or Chi-BEAM before ASCT. Researchers will compare the efficacy and safety of the two groups.

This is a prospective, multicenter, randomized controlled, open trial. The primary endpoint was 2-year PFS The secondary endpoint was： 2-year overall survival (OS). CR rate at 3 months post-transplant evaluation Hematopoietic reconstitution time Non-recurrent mortality (NRM)

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed patients with newly treated PTCL (including NT/ K-cell lymphoma), except for ALK (+), have CR or PR after first-line treatment;
2. Renal function needs to be satisfied: creatinine clearance ≥80ml/min, creatinine less than 160μmol/L; Liver function requirements: ALT and AST≤2 times the upper limit of normal; Total bilirubin ≤2 times the upper limit of normal; Lung function should meet: FEV1, FVC, DLCO≥50% predictive value; Cardiac function must be satisfied: left ventricular ejection fraction ≥50%, asymptomatic arrhythmia.
3. Age between 18 and 65 years old, male and female;
4. ECOG physical strength score 0-1;
5. Neutrophil absolute value ≥1.5×109/L, platelets ≥ 70×109/L, hemoglobin ≥ 90g/L; Number of CD34+ cells ≥ 2.0×106/kg body weight;
6. Expected survival time ≥3 months;
7. Voluntarily sign written informed consent.

Exclusion Criteria:

1. Lymphoma involving the central nervous system
2. Active hepatitis B or C virus infection;
3. Active infection;
4. HIV infected persons;
5. Evidence of cirrhosis or liver fibrosis;
6. Ecg showed QTc \> 500ms;
7. Persons with mental disabilities/unable to obtain informed consent;
8. Patients with drug or chronic alcohol abuse that may affect the evaluation of study results;
9. Pregnant and lactating women and women of childbearing age who do not want to take contraceptive measures;
10. The researcher determines that it is not suitable to participate in this study
Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM)

Screening for microcephaly is important at birth and during early childhood. The Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM) aims to establish a multicentric surveillance system for microcephaly in newborns and infants, to develop a new head circumference reference and microcephaly criteria basing on the local population in Guangzhou, to improve the prediction model of microcephaly, and to follow up the outcomes of the children diagnosed with microcephaly.

Microcephaly is associated with neurological dysfunctions in infants and children. There is not a uniform diagnostic criteria for microcephaly. The World Health Organization (WHO) recommended a criteria of head circumference (HC) less than 2 standard deviations (SD) below the mean of the Intergrowth-21 standard, which was found not applicable to the newborns and infants in Guangzhou.In the GSCSM, the HC measures of newborns are conducted by trained midwives using a standard tool, and extensive information including adverse perinatal outcomes are collected. Longitudinal follow up of infants' neurodevelopment in cognitive, motor, emotional and other domains are also to be conducted. The GSCSM intends to find out the infants who are 'real microcephaly' and most at risk of short-term or long-term adverse outcomes in Guangzhou.

Eligibility Criteria:
Inclusion Criteria:

1. Newborns born after 24+0 weeks of gestation
2. Newborns delivered at the study hospitals

Exclusion Criteria:

1. With major congenital abnormalities
2. Multiple births
CorEvitas Atopic Dermatitis Registry: a Study of Post Approval Drug Safety and Effectiveness

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for patients with atopic dermatitis under the care of a licensed dermatologist or qualified physician extender. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Condition or disease :

Atopic Dermatitis

The objective of the CorEvitas Atopic Dermatitis (AD) Registry is to create a national cohort of patients with atopic dermatitis. Data collected will be used to extensively evaluate the effectiveness and safety of medications used to treat atopic dermatitis. This will be done through the standardized collection of patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), and the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.

Eligibility Criteria:
Inclusion Criteria Has been diagnosed with AD by a dermatologist or qualified dermatology provider.

2) Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.

3) Willing and able to provide consent for participation in the registry. 4) Willing and able to provide Personal Information (full legal name, sex, date of birth, home address zip/postal code, and email address OR phone number at a minimum) if required based on registry location and applicable laws and regulations. 5) Has been prescribed a new Enrollment Eligible Medication. A new therapy is a medication that the subject has never taken before.

1. At the time of registry enrollment OR
2. Within 12 months prior to registry enrollment

Exclusion Criteria:

1)Is participating or planning to participate in a blinded clinical trial for an AD drug.

Follow-Up Criteria

Registry Follow-Up data collection should be done at the time of routine clinical encounters approximately every 6 months. Routine or standard of care clinical encounters may occur in between two registry visits, but the data collected in the Follow-Up forms should cover the time period since the last registry visit.

For planning purposes, each Follow-Up visit is anchored to the date of the last eligible registry visit. A Follow-Up visit is eligible for payment if 150 days have passed since the last visit submission. A Follow-Up visit is not eligible for payment if conducted less than 150 days since the last registry visits except when the EARLY Follow-Up visit Criteria are satisfied.

EARLY Follow-Up Criteria

A registry Follow-Up visit should be conducted whenever a patient is prescribed or receiving the first dose of a new Eligible Medication even if less than 150 days have passed since the last registry visit. When the EARLY Follow-Up criteria are met, the next anticipated registry visit is calculated from the date of the Early Follow-Up visit.
Identification of Risk Factors for Cardiovascular Disease and Cancer in Korean Population: A Prospective Cohort Study

Cancer and cardiovascular disease are the global leading causes of death. These two disease entities are multifactorial disease that are caused by several factors. The aim of this prospective cohort study was to investigate the status of risk factors profiles and health related behavior in Korean population, and to discover novel risk factors associated with the occurrence of endpoint events.

This is a single center, observational, prospective cohort study. The primary outcomes include the incidence of MACE (major adverse cardiovascular events) and the incidence of any malignancy. We plan to collect the baseline information at enrollment and the occurrence of clinical endpoint events will be followed for at least 10 years. The study will enroll 510,000 subjects aged ≥19 years who underwent a general health screening in Korea.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 19 years and older who underwent a general health screening at the health promotion center of Ulsan University Hospital (Ulsan, Korea)
* Subjects have to agree to participate by signing a consent

Exclusion Criteria:

* Subjects who cannot or reject to sign the consent form.
Hip Osteoarthritis and Foot Orthoses Trial (HOOT)

This trial is a randomized feasibility trial to determine the feasibility of comparing two different shoe inserts and on pain, quality of life and physical activity associated with hip osteoarthritis.

Participants will be randomized to one of two groups - contoured prefabricated foot orthoses or flat shoe inserts (the comparator). Participants will be asked to use the inserts daily for a six week period. Adherence to the intervention will be monitored using a daily diary, as well as adverse events and co-interventions. The primary outcome is feasibility domains (Demand, Implementation, Acceptability, Practicality) with secondary outcomes of change in hip-related pain and quality of life and physical activity levels. The primary time-point will be 6-weeks.

Eligibility Criteria:
Inclusion Criteria:

Primary symptomatic and radiographic hip OA, in accordance with the American College of Rheumatology

(i) aged \> 45 years;

(ii) pain in the hip or groin for more than 3 months;

(iii) average pain intensity over the past week of \> 3 out of 10 (Numerical Rating Scale) during functional tasks like walking, climbing stairs or climbing in/out of a car;

(iv) radiographic confirmation of hip osteoarthritis with a Kellgren-Lawrence score ≥ 2 within the last 12 months;

(v) mild to moderate disability indicated by;

1. able to reciprocally ascend and descend 10 stairs unaided,
2. able to safely walk one city block, and
3. able to jog five meters if required

Exclusion Criteria:

(i) other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional (Doctor, Physiotherapist, Podiatrist etc) in the last 6 months;

(ii) have received active treatment for their hip pain by a health professional (eg physiotherapist) in the last 3 months;

(iii) history of hip trauma or surgery on the affected side;

(iv) corticosteroid use (oral or intra-articular injection) in the past 3 months

(v) neurological impairment or condition affecting lower limb function

(vi) conditions or factors affecting ability to take part in the intervention, e.g., unavailable for a 6 week intervention period, routine use of gait aids, uncontrolled hypertension, or morbid obesity (body mass index \> 40);

(vii) Use of foot orthoses in the previous 12 months

(viii) systemic inflammatory disease (e.g. rheumatoid arthritis);

(ix) unable to write, read or comprehend English.
Prediction of Jaundice in Term Infants

The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Jaundice occurs in most human neonates during the several days after birth. The objective of this study was to describe total bilirubin production in healthy term infants as a means of understanding the differences in jaundice pigment production associated with various common clinical circumstances.

Eligibility Criteria:
Inclusion Criteria:

* Infants born via cesarean delivery (to ensure subjects would still be hospitalized and available for ETCOc measurement and blood sampling on day 3 postpartum)
* Delivery within each center's scheduled recruitment period (to maximize nursing availability and minimize cost)
* Birth weight \>2500 g
* Gestational age \>37 weeks

Exclusion Criteria:

* Any illness that would require admission to the neonatal intensive-care unit (NICU) within 8 hours of birth
Cox-2 Inhibition in Radiation-induced Oral Mucositis

Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrition and quality of life and may necessitate interruptions in radiation therapy, thus adversely affecting cancer therapy outcomes. This study examined the use of an anti-inflammatory medicine to reduce pain and severity of oral mucositis.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients who will be receiving at least 5000 centigray (cGy) radiation therapy to at least 2 of 14 pre-defined areas in the oral cavity.
* Women of childbearing potential must agree to use a medically accepted form of contraception during the course of the study. Women of childbearing potential must have a documented negative pregnancy test within fourteen days of enrollment in the study.
* Patient's willing and able to provide written informed consent for the study.

Key Exclusion Criteria:

* Patients with known hypersensitivity to celecoxib or other COX-2 inhibitors.
* Patients who have experienced asthma, urticaria, or allergic-type reactions after taking salicylates (e.g. aspirin) or Non-steroidal anti-inflammatory drugs (NSAIDs).
* Patients who have demonstrated allergic-type reactions to sulfonamides.
* Patients with a history of gastric, esophageal, pyloric channel or duodenal ulcer disease or gastrointestinal bleeding.
* Patients with a history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) or pancreatic disease.
* Patients with severe hepatic impairment.
* Patients with advanced renal disease.
* Patients with a significant bleeding disorder.
* Patients under the age of 18 or over the age of 75.
* Women who are pregnant or nursing.
* Patients with a history of thromboembolic events including myocardial infarction, pulmonary embolism, deep venous thrombosis, transient ischemic attack and ischemic cerebrovascular accident (stroke).
* Patients who have had coronary angioplasty, coronary artery bypass surgery or another cardiac revascularization procedure.
* Patients with a history of a cardiac arrhythmia requiring anti-arrhythmic therapy, angina pectoris or congestive heart failure.
Cultural Adaptation of EMDR for Major Depressive Disorder and Compaire Its Online and Face-to-Face Testing

The present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, determine its treatment fidelity, and then clinically test its efficacy in the treatment of Major Depressive Disorder in Pakistan by utilizing both in-person and online modalities of EMDR therapy.

Background and Aim: Major Depressive Disorder(MDD) is a globally leading cause of disability. Currently, psychotherapies like Eye Movement Desensitization and Reprocessing(EMDR) and Cognitive Behavioral Therapy(CBT) are widely available. Since EMDR originated in the United States, it may not be completely appropriate for non-Western countries like Pakistan, necessitating possible modifications. Moreover, therapists have long practiced face-to-face EMDR, but recently, online EMDR modalities have emerged. Nonetheless, it is surprising that there is a dearth of research not only on adaptations of EMDR in Pakistan but also on testing its clinical efficacy, particularly its online modalities. Considering this, the present study aims to develop a culturally and methodologically adapted EMDR therapy protocol, and clinically evaluate its efficacy in treating MDD in Pakistan by comparatively administering it through in-person and online modalities. Methods: This study will employ a mixed mode Randomized Controlled Trial design with a consecutive sample of (n=90). Patients will be treated by using adapted EMDR therapy protocol. Patients will be randomly allocated to in-person and online modes of EMDR. Various qualitative methods and quantitative techniques will be employed to data. Conclusion: This study is likely to make significant contributions by delivering insights about how to develop culturally and methodologically adapted EMDR. This study will extend our knowledge about the comparative effectiveness of EMDR in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

1. The patient should exhibit symptoms of Major Depressive Disorder.
2. Male and female patients will be chosen equally.
3. Patients between the ages of 20 and 50 will be selected.
4. Patients should preferable be "treatment-naïve," meaning they have no recent history of any psychotherapy or medication.

Exclusion Criteria:

a. There must be no significant neuropsychological or cognitive disorders among the patients
Night Time Walking to Improve Glycaemic Control in Healthy Adults

Randomised crossover trial to compare early vs late walking on postprandial glycaemic response at night time.

In this crossover trial, eligible participants will be randomised to a 30-minute bout of physical activity (30 minute walk) either during the day or after an evening meal. The postprandial response to the evening meal will be analysed.

Eligibility Criteria:
Inclusion criteria

* Men and Women aged 18 to 65 years of age
* Waist circumference of \<94cm and \<80cm for Caucasian males and females, respectively
* Waist circumference of \<90cm and \<80 cm for Asian males and females, respectively
* Willingness to provide written informed consent and willingness to participate and comply with the study

Exclusion criteria

* Current or recent treatment (within 6 months) with medications that influence blood glucose
* Fasting blood glucose ≥ 7 mmol/L
* Individuals diagnosed with type 1 or type 2 diabetes mellitus, chronic gastrointestinal disorders (including inflammatory bowel disease and celiac) or any other condition deemed unstable
* Serious health conditions that may affect participation e.g. liver or thyroid dysfunction, recent major surgery
* Not able to walk for 30 mins at 5-5.5 km/hr
* Women planning pregnancy, pregnant or lactating.
A Phase 1, Open-label Study Evaluating the Pharmacokinetics and Drug-drug Interaction of VX-993 in Healthy Adults

The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2)
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before the first study drug dose

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.
Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome

Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Ayurveda is a traditional Indian medicine: as a whole medical system it consists of diagnostic procedures and complex treatments. Ayurveda-treatment is based on Ayurvedic diagnosis and has a special focus on lifestyle and nutritional counseling, based on the individual constitution of the patient. Ayurvedic counseling can easily be followed by the patients in their day-to-day life and is an inexpensive way of self-care. In Ayurveda it is often used for the treatment of burnout-syndrome. However, no systematic data is available on its effectiveness in comparison to conventional standard diet and lifestyle counseling. The aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age between 18 and 50
* mother of ≥ 1 child ≤ 12 years of age
* job, education or studies ≥ 20 hours per week
* subjective feeling of physical and mental exhaustion since ≥ 3 month
* ≥ 18 points in the MBI Subscale "emotional exhaustion" at screening

Exclusion Criteria:

* change of psychotropic drug medication ≤ 6 weeks before inclusion
* pregnancy or breastfeeding
* pre-diagnosed major depression
* serious chronic co-morbidity (e.g. CHF NYHA IV)
* serious acute somatic health conditions
* intake of opiods
* simultaneous participation in other trials
* praticipation in other trials during ≤ 6 month before inclusion
Relationship Between Degree of Hypofunction and Vestibular Tests in Patients With Vestibular Hypofunction

Patients with complaints of dizziness and balance problems will be included in the study. Inclusion criteria for the study are; being between the ages of 12-85, having a diagnosis of peripheral vestibular hypofunction. Exclusion criteria from the study are; not being able to communicate, having a diagnosis of central vestibulopathy and having mental disorders. Demographic information form, vestibular tests, balance tests will be used in the evaluation. The demographic information form includes demographic information (name, surname, gender, smoking, alcohol use, etc.) and clinical conditions (past illnesses and/or surgeries, medications used, whether there is a history of falls, if any, frequency, whether they are afraid of heights and uncomfortable in the dark, etc.). The patients will be diagnosed with videonystagmography (VNG) after the decision of the ENT physician, and the degree of hypofunction will be recorded. Vestibular and balance tests will be applied to the patients in a clinical setting. At the end of the study, it will be examined whether there is a relationship between the degree of vestibular hypofunction and the vestibular tests applied in the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Being between 12-85 years old
* Having peripheral vestibular hypofunction
* Having good communication skills and participating in the work willingly

Exclusion Criteria:

* Having wavy vertigo
* Having mental retardation
* Failure to communicate
* Severely limited mobility
* Having acute Meniere's disease
* Having a neurological problem
Improvement of Endothelial Function by EGCG

Cardiovascular diseases are a major cause of morbidity and mortality worldwide. Impaired endothelial function (assessed as flow-mediated dilation) represents an early marker for later cardiovascular events. Epidemiological and experimental studies suggest that consumption of tea is associated with lower progression of atherosclerosis and reduced cardiovascular mortality.

Tea contains high amounts of polyphenols with important biological activities. The green tea catechin epigallocatechin-3-gallate (EGCG) is the most potent physiologically active compound in vitro. However, little is known about its contribution to beneficial effects of tea in vivo.

In this crossover study the impact of a single dose of EGCG applied in different forms (green tea beverage, green tea extract and EGCG) on flow-mediated dilation is investigated in healthy volunteers two hours after ingestion. The amount of EGCG (200 mg) corresponds to appr. 0.5 L of green tea. The results of the study will elucidate the contribution of EGCG in cardiovascular protective effects of green tea in vivo. The outcomes will provide insights about the role of EGCG in different application forms to improvements of endothelial function in humans.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers
* 20-50 years
* BMI \< 27 kg/m2
* Cholesterol \< 240 mg/dl

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Conditions with impaired endothelial function
* Smoking
* Regular drug use
* Alcohol abuse
* Regular tea drinkers