cyrilzakka/clinical-trials huggingface dataset:
Zhejiang Nutrition and Health Study

This project aims to explore the relationship between healthy lifespan and nutrition through a 10-year longitudinal study in Zhejiang Province. The cohort will include individuals in a wide range of age groups. The demographic, diet, lifestyle information, health status, and corresponding bio-samples will be collected carefully. It will give a deeper insight to the relation between nutrition and healthy aging and longevity. Ultimately, this research will contribute to evidence-based nutrition interventions to improve health outcomes and enhance quality of life.

This project aims to elucidate the relationship between healthy lifespan and nutrition through the establishment of a large-scale cohort of participants and longitudinal follow-ups spanning around 10 years in Zhejiang Province. The cohort will comprise individuals in a wide range of age groups starting at 6 years old. The participants will provide demographic information, anthropometry measurements, detailed diet, lifestyle data and health status, including 3-day dietary records and long-term food intake frequency recalls. Integrated with previous information, diverse bio-samples will also be collected to establish a multi-dimensional biobank. It will give a deeper insight to the relation between nutrition and healthy aging and longevity. Ultimately, this research will contribute to the development of evidence-based nutrition designed to improve health outcomes and enhance the quality of life for individuals of all ages.

Eligibility Criteria:
Inclusion Criteria:

* Chinese citizens who have resided in the surveyed area for at least 6 months before the survey within the last 12 months.
* Aged 6 years or older.
* They are included as resident households, which are comprised of people living together in one place based on family relationships, and at least one resident with permanent household registration.

Exclusion Criteria:

* Residents living in functional zones such as construction worker dormitories, military barracks, schools, nursing homes, etc.
The Efficacy and Safety of Risperidone in the Treatment of Adolescents With Schizophrenia

A clinical study to compare the safety and effectiveness of two different dose ranges of risperidone solution in the treatment of adolescents with a diagnosis of schizophrenia.

This is a clinical study of an investigational drug called risperidone in the treatment of schizophrenia in adolescents. Initially children (age 2 to 12 yrs) and schizophreniform subjects were also allowed but excluded following protocol amendment.

The study will include approximately 260 patients aged 13 to 17 years with a diagnosis of schizophrenia. Subjects will be randomly assigned to one of two groups on enrollment and will be given risperidone as an oral solution each day for 8 weeks at doses within one of two dose different ranges, according to the assigned study group.

Initially the two dose range were 0.15-0.4 mg/day and 1.5-4mg/day but were changed in protocol amendment to evaluate the maximum tolerated dose with a minimum of 3.5mg/day and maximum of 6mg/day (resp. 0.35 and 0.6mg/day in low dose treatment arm) Risperidone lower dose (0.35-0.6 mg/day \[subjects \>=50kg\] or 0.007-0.012 mg/kg/day \[subjects \<50 kg\]) as 0.1 mg/mL oral solution or risperidone higher dose (3.5-6 mg/day \[subjects \>=50 kg\] or 0.07-0.12 mg/kg/day \[subjects \<50 kg\]) as 1 mg/mL oral solution for 8 weeks. Daily dose can be given all at once or through 2 administrations (in morning and evening); the dose is increased based on efficacy and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be eligible for study enrollment if they: are adolescents between the ages of 13 and 17 years
* have a confirmed diagnosis of schizophrenia and are suffering from an acute episode
* provide their assent and parental informed consent to participate
* are otherwise relatively healthy on the basis of a medical and physical examination
* and are able to be in-patients for approximately 2 weeks.

Exclusion Criteria:

* Subjects will be excluded from the study if they: meet the criteria for psychiatric disorders other than schizophrenia
* have moderate or severe mental retardation
* fail to respond to treatment with at least two typical or atypical antipsychotics
* have a history of substance dependence within the 3 months before screening
* are considered at risk for suicidal or violent behavior
* have a seizure disorder
* have a history of neuroleptic malignant syndrome, similar encephalopathic syndrome, or tardive dyskinesia
* or receive prohibited medication within a specified period before screening.
Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448

Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.

This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.

It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.

Eligibility Criteria:
Inclusion Criteria:

1. Informed of the investigational nature of this study and voluntarily agree to participate in this study.
2. Subjects with BMI range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg
3. Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
4. Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent

Exclusion Criteria:

1. Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness
2. Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
3. A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula
4. Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
ASSESSMENT OF DRY EYE DISEASE IN ACNE PATIENTS RECEIVING ISOTRETINOIN

The study aims to explore the effects of isotretinoin therapy on the dry eye parameters in acne vulgaris patients \& determine if it is dose-dependent or not.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe acne on isotretinoin

Exclusion Criteria:

* Occular diseases causing dry eye
* Pregnant females
A Research Study of How Teens With and Without an Anxiety Disorder Make Decisions

The purpose of this trial is to study how teens with and without an anxiety disorder make decisions.

This is a brain imaging study using functional magnetic resonance imaging (fMRI) in adolescents between the ages of 13 and 17.

Preliminary analyses of behavioral data showed no group differences in response times during the decision-making games. However, behavioral ratings of certainty during the task showed differences between groups. Anxiety-disordered participants indicated lower levels of certainty during the most uncertain conditions of the task (p \< .05). This difference was consistent with the study hypothesis. Within-subjects analyses of the decision-making tasks showed that subjects responded as expected. Reaction times (RT) during uncertain conditions of the HiLo-Game were significantly longer than during more certain conditions (p = .001). Diary Task RTs for rating ambiguous situations were significantly longer than ratings of unambiguous situations (p = .019). Preliminary Analyses showed a significant correlation between Intolerance of Uncertainty (IU) and RT during the Marble Task (r = -0.54, p \< .05). Preliminary analysis also showed significant correlation between ratings of level of anxiety during the diary task and IU, IS, MASC and the child version of the SCARED. These preliminary results were not submitted for publication.

Eligibility Criteria:
Inclusion Criteria:

* Must meet diagnostic criteria for Generalized Anxiety Disorder, Separation Anxiety Disorder or Social Phobia, OR must be free of medical, psychiatric, neurologic conditions and learning disorders (healthy controls)
* Sufficient intelligence to understand the study and provide truly informed consent; will be determined by educational history

Exclusion Criteria:

* Having any major medical conditions that may interfere with interpretation of results or be associated with risk in an MRI environment (history of metal implants, or contraindications to MRI scanning for research purposes, including pregnancy)
* Current evidence of Autism, Major Depression, Substance Abuse, Obsessive Compulsive Disorder, Post-traumatic Stress Disorder, Panic Disorder, Tic Disorders, significant suicidality, lifetime history of psychosis or mania.
* Estimated Full-Scale IQ below 80
* Inability or unwillingness to remain still during scanning
* Inability or unwillingness to provide assent
* Absence of signed consent by parent or legal guardian
* Current history of sexual or physical abuse in the family, or past sexual or physical abuse if there is ongoing Department of Social Services (DSS) involvement
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in Gaza

The objective of this study is to determine whether participation in a mind-body skills program by war-traumatized adults in Gaza will result in improvement of posttraumatic stress symptoms and depression, and will increase posttraumatic growth compared to a control group.


Eligibility Criteria:
Inclusion Criteria:

* having experienced a political violence or war-related criterion A stressor
* meeting the American Psychiatric Association (DSM-IV TR) criteria for PTSD according to screening scores on the PTSD Checklist- Civilian version

Exclusion Criteria:

* former psychosocial or medical treatment for mental health conditions
* significant cognitive impairment
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.


Eligibility Criteria:
Ocular Inclusion Criteria Study Eye:

* Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters
* Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)
* GA area must be \>/= 0.5 disc area (1.25 mm\^2)

Ocular Exclusion Criteria, Study Eye:

* GA in the study eye due to causes other than AMD
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
* Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
* Prior treatment with photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria, Both eyes:

* Evidence of prior or active CNV
* Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e. ocular or systemic) within the last 6 months
A Modified (Retro-Tubercle) Opening Wedge High Tibial Osteotomy Versus the Conventional Technique

The present study was conducted among a group of Iranian patients suffering from varus knee in order to compare advantages and disadvantages of ROWHTO (Retro-Tubercle Opening Wedge High Tibial Osteotomy) technique when compared with previously described approaches of opening-wedge osteotomy.

There are various methods for correcting varus deformity; therefore the best surgical method must be individualized. We concluded that in a varus knee where only correction in the coronal plane without patella infra, changes in Q- angle, tibial plateau inclination is all that is needed, a retro- tubercle medial opening- wedge osteotomy is the preferred approach.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic varus deformity of the knee with 2 or more degrees of anatomical axis varus without ligament injury

Exclusion Criteria:

* fractures through compartments of the knee or the patella
* osteoarthritis other than in the medial compartment
* 10 degrees or more extension lag
* tibial malrotation
Different Sutures in Hand Surgery

This study aims to assess the relationship between overall satisfaction with treatment in a group of randomized patients undergoing elective hand surgery using either absorbable (4-0 Chromic) or non-absorbable (5-0 Nylon) sutures. The investigators will also assess factors associated with wound concerns, pain intensity, magnitude of limitations, and physical function within one month of surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing common day-case elective hand surgery under local anesthesia, one of the following (initial) procedures:

  * Carpal tunnel release
  * Trigger finger release
  * Ganglion excision
  * Excisional biopsy
  * De Quervain release
  * Dupuytren fasciectomy
  * Any other minor hand surgery
* Patients aged 18-89
* Able to provide informed consent
* Able to understand English or Spanish to complete questionnaires
* Patients who have an email-address or phone number (needed for follow-up)
* UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Orthopaedic Specialists of Austin.
* Available for follow-up contact after 4 weeks

Exclusion Criteria:

* Patients not able to give informed consent
* Patients using corticosteroids
* Patients with one of the following comorbidities: bleeding disorder, immunodeficiency, collagen vascular disease.
* Patients known to be allergic to suture materials
* Revision procedures
Efficacy and Safety on the Use of Bisphosphonates in Paediatrics

The investigators suppose that the impact of bisphosphonate therapy is beneficial on the bone during the growth period with few adverse events.


Eligibility Criteria:
Inclusion Criteria:

* be under 18 years of age
* have been treated by intravenous bisphosphonates for primary or secondary osteoporosis

Exclusion Criteria:

* be over 18 years of age
EVALUATION OF THE EFFECT OF POLYVINYLPYROLIDONE AND SODIUM HYALURONATE GEL ON PALATINAL WOUND HEALING

The aim of this clinical study was to evaluate the effect of polyvinylpyrrolidone sodium hyaluronate gel on palatal wound healing, pain, and bleeding after free gingival graft surgery. This study included 32 systemically healthy patients who required free gingival graft surgery. After the operation, the test group received polyvinylpyrrolidone sodium hyaluronate gel in addition to chlorhexidine gluconate mouthwash, whereas the control group received only chlorhexidine gluconate mouthwash. VAS scale was used to evaluate palatal pain, burning, and chewing discomfort, WHI was used to evaluate wound healing, and H2O2 foaming test was used to evaluate epithelialization. VAS and bleeding values were recorded on postoperative day 1; VAS, WHI, H2O2, and bleeding values on postoperative days 3, 7, and 14; and WHI, H2O2, and bleeding values on postoperative day 28.


Eligibility Criteria:
Inclusion Criteria:

* Able to adapt to the study, not having a physical or psychological condition that would prevent surgical procedure under local anesthesia, and being able to follow the planned operation and control sessions
* Patients who consciously accept and sign the detailed informed consent form regarding the study that will be explained to them verbally
* Insufficiently attached gingiva on the mandibular or maxillary vestibular teeth and implant surfaces

Exclusion Criteria:

* Presence of infection and inflammation in the recipient and donor area
* Presence of systemic disease
* Women who are pregnant, suspected of being pregnant or breastfeeding
* Smoking
* Orofacial neurological symptoms
Effects of Sensomotoric Insoles on Postural Control in Elderly People

People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. One Group is getting no insoles, the second group is getting modern sensomotoric insoles, and the third group is getting normal standard insoles. All are passing a 6 week proprioceptive training.

Main outcome measurements are posturography at baseline, 3 weeks and 6 weeks. Secondary measurements are ABC-Scale, Tinetti Gait and balance test and functional reach test at baseline and after 6 weeks.

People with weak balance ability or subjective feeling of dizziness and unsure gait are separated into 3 training-groups. Exclusion criteria are structural neuropathic cause for dizziness, severe ocular deficience, cochlear causes for dizziness.

The 3 Groups differ in following criteria:

Group 1: Gets basic insoles after 3-D-Scan of the foot Group 2: Gets sensomotoric insoles (Jahrling) after 3-D-Scan of the foot. Group 3: Control-Group = no insoles

Alle groups are doing a 6 weeks proprioceptive training 2 times a week for 45min. Balance-Ability is measured by a posturographic plate prior to the training, after 3 weeks training and after 6 weeks of training. ABC-Score, Tinetti Gait and Balance test and functional reach test are secondary outcome measurements and are evaluated prior the training and after 6 weeks of training.

Eligibility Criteria:
Inclusion Criteria:

ABC-Scale \< 70% Functional reach test \< 30cm Subjective feeling of unsure gait or several falls in the last 5 years

Exclusion Criteria:

Structural pathologies in the balance system Neuropathologies like Polyneuropathy
The Kallikrein-Kinin System in Cardiac Surgery

We aimed to established an interlink among the kallikrein-kinin system (KKS), endothelial dysfunction and cardiac inflammation in response to cardiosurgery , using clinic investigation.

The KKS, which is located on the vascular endothelium, plays a pivotal role in maintaining cardiovascular homeostasis. Tissue kallikrein (TK), a serine protease and a key enzyme of the KKS, is responsible for cleaving low-molecular-weight kininogen into bradykinin and kallidin. Under normal physiological conditions, the activation of the B2 receptor (B2R)/endothelial nitric oxide synthase (eNOS) signaling pathway leads to the transient release of nitric oxide (NO), resulting in cardiovascular protection. However, during reperfusion injury, the activation of the B1 receptor (B1R)/inducible nitric oxide synthase (iNOS) pathway leads to excessive NO production, promoting inflammation and cellular injury. Therefore, it is hypothesized that the KKS plays a critical role in the early stages of reperfusion injury during cardiac surgery with cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

1) Willing to participate in the study. 2) Age ≥ 18 years and ≤ 80 years. 3) Patients undergoing cardiac surgery: (coronary artery bypass grafting, heart valve surgery, Morrow operation, aortic dissection surgery).

Exclusion Criteria:

1) Patients with heart failure. 2) Patients experiencing adverse events during surgery. 3) Solid organ or bone marrow transplant recipients. 4) Patients with autoimmune diseases, tumors, or those who received high-dose steroid or immunosuppressant therapy within the past two months. 5) Deemed unsuitable for participation in this study by the researchers' judgment.

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Pain Education in Chronic Low Back Pain

The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.

The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patients with low back pain of musculoskeletal origin for at least 3 months
* Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
* Years of education: over 13
* Italian mother-tongue

Exclusion Criteria:

* Presence of neurological symptoms on provocative tests
* Recent surgical procedure
* Patients suffering from fibromyalgia or other rheumatological pathology
* Psychiatric pathologies
Endometrial Priming for Embryo Transfer

The aim of this trial is compare two different endometrial priming protocols

* women that receive oral estrogens
* women that receive transdermal estrogens


Eligibility Criteria:
Inclusion Criteria:

* Women between 18-50 years old with desire of children and needs of embryo transfer.
* Plasma prolactin less than 30.
* Uterine cavity that allow pregnancy, body mass index between 20-30.
* And signed consent inform.

Exclusion Criteria:

* History of estrogen dependent cancer, unknown origin vaginal bleeding.
* Ovarian cyst.
* Contraindications to be pregnant.
* Estrogen allergy.
Isometric Exercise for People With Raised Blood Pressure

High blood pressure affects many people in the United Kingdom. People with raised blood pressure (140-159/90-99 mmHg) are recommended to make changes in their lifestyle (e.g. smoking/alcohol/diet/exercise) and/or medication in order to reduce their blood pressure. Current knowledge suggests that a particular type of exercise - isometric exercise - can lower blood pressure. Isometric exercise involves holding a fixed body position for a short period of time. As most of the information about the benefits of this type of exercise comes from laboratory-based studies, researchers want to find out if it is possible for GP practices to offer NHS patients with clinically high blood pressure an isometric exercise plan to do at home and how it might affect their blood pressure over 6 months. They will also find out the experiences of those doing this type of exercise and whether it can be done consistently at home over time.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or over
* Clinic systolic BP 140-159 mmHg
* Able to provide informed consent

Exclusion Criteria:

* Currently taking anti-hypertensive medication
* White coat hypertension, as evidenced by averaged home systolic BP \<135 mmHg
* Inability to undertake study intervention (isometric exercise)
* Previous history of any of the following:

  * Diabetes mellitus (Type 1 or type 2)
  * Ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure)
  * Moderate or severe stenotic or regurgitant heart valve disease
  * Atrial or ventricular arrhythmia
  * Stroke or transient ischaemic attack
  * Aortic aneurysm and/or peripheral arterial disease
  * Uncorrected congenital or inherited heart condition
* Estimated glomerular filtration rate \<45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
* Documented left ventricular ejection fraction \<45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
* Documented urine albumin:creatinine ratio \>3.5 mg/mmol
* Inability to provide informed consent
* If female, pregnancy or currently breast feeding
* Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or other interventional study
* Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study