cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study of Online Active Play Program With Adolescents

To assess the efficacy of an online, active play program (Revival Active Program) in reducing the symptoms of anxiety and depression in community-based adolescents,, a retrospective community based participatory research was conducted with 32 adolescents aged between 11-17 years old.

Program was conducted during Covid-19 lockdown from March 2020 to June 2020 to support children and families in isolation.


Eligibility Criteria:
Inclusion Criteria:

* Children at the online program for whole duration
* indicating a symptom level of, at minimum, above mean on anxiety and/or depression on self-report measures
* Parental consent before stating the program

Exclusion Criteria:

* Children at normal levels of mental health screening
* Children who did not complete the intervention period
Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study

Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer factor (TLCO), a higher prevalence of clinical depression, reduced health status and exercise intolerance have been observed in patients with sarcoidosis.

Reduced health status has been related to decreased pulmonary function, depressive symptoms, and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea, an insufficient heart rate response, decreased arterial oxygen tension during exercise, excessive and inefficient ventilation and by respiratory muscle weakness.

In the past, exercise capacity was shown to be limited by skeletal muscle weakness in patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied by Miller et al terminated their peak exercise test due to "leg complaints". Skeletal muscle weakness is therefore still assumed to be present in patients with sarcoidosis.

Treatment with oral corticosteroids, clinical symptoms of depression, myositis, self-reported complaints of fatigue and high circulating levels of tumour necrosis factor-α (TNF-α) are all present in patients with sarcoidosis and can all affect skeletal muscle force and exercise capacity. Additionally, low levels of circulating insulin-like growth factor I (IGF-I), which can be induced by high levels of TNF-α, and high circulating levels of interleukin (IL)-6 and IL-8 (CXCL8) have been associated with skeletal muscle weakness. These interleukins are part of the current concept of the immunopathogenesis of sarcoidosis16 and may be raised in patients with stable sarcoidosis.

Recent studies have shown that pulmonary rehabilitation program can lead to improve in the health status and anxiety among patients with chronic obstructive lung disease .However, no study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

* Stable pulmonary sarcoidosis with no change in medication during the last 3 months.

Exclusion Criteria:

* Any significant other pulmonary and\\or co-morbidity that can affect exercise tolerance.
* Chronic steroid treatment more than 5 mg/day.
* Previous lung surgery.
* Advanced heart failure (NYHA III-IV )
* Malignancy during the last 3 years
Can a Vocal Stimulus Provoke Spontaneous Breathing in an Ischemic Stroke Patient Dependent on Mechanical Ventilation?

Vocal stimulation may encourage spontaneous breathing in patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation will serve as the control group.

Vocal stimulation may encourage breathing in ventilated patients dependent on mechanical ventilation.

The study will include 30 patients on mechanical ventilation that will be intervened by the vocal stimulation and 30 patients on mechanical ventilation that will be our control group.

Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke men and women older than 18 years old and younger than 80 years old

Exclusion Criteria:

* coma from other reasons other than ischemic stroke hemmorhagic stroke active malignancy renal failure
Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer

The protocol involves measurement of 25 hidroxy vitamin D, gene expression of cytochrome and vitamin D receptor , endoxifen, tamoxifen, exemestane, and other metobolites related to nutrition and endocrine metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer women under endocrine therapy or recurrence of disease after endocrine therapy
* Signed consent

Exclusion Criteria:

* Mental retardation
Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie

This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.

Infusion times will be gradually shortened if tolerability allowes.

After two cycles with normal infusion times, infusion time will be shortened to 15 mintues en 10 minutes subsequently if no infusion reaction occurs.

Patient satisfaction will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.
* 18 years and older.
* No known history of increased susceptibility to immunological reactions.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.

Exclusion Criteria:

* Other research medication within 4 weeks of the start of the study.
* Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions
* Dosage deviates from standard protocol
* Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).
Uterine Niche Symptoms and US and Hystroscopic Findings

correlation between clinical ,soonographic and hysteroscopic findings in patients with uterine niche


Eligibility Criteria:
Inclusion Criteria:

* patient with uterine niche previous cs

Exclusion Criteria:

abnormal uterine bleeding

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Masticatory Performance in Bilateral Balanced Occlusion and Lingualized Occlusion in Complete Denture

This is a randomized control trial to compare masticatory performance in complete dentures with bilateral balanced occlusion or lingualized occlusion.

This study is a randomized control trial to compare the masticatory efficiency of complete dentures with bilateral balanced occlusion with that of lingualized occlusion . Grouping of participants was carried out. Participants divided into two groups one receiving complete dentures with bilateral balanced occlusion and the other group receiving complete dentures with lingualized occlusion . Each participant provided with 15g of peanuts and instructed to chew until ready to swallow . The chew material than spat into the designated container and participants asked to rinse their mouth with water , with the rinse being collected in the same container . The collected material than sieved through 10-Mesh sieve followed by drying the sieved content on blotting paper for 30 minutes. The dried material subsequently weight with an electric balance with precision of 0.01 grams . Masticatory efficiency assessed through mean weight of chewed peanuts.

Eligibility Criteria:
Inclusion Criteria:

1. Participants aged 45-65 years.
2. Both genders included.
3. Edentulous patients requiring complete denture.
4. Patients willing to participate in the study .

Exclusion Criteria:

1. Participants not willing to participate in the study.
2. Participants with systemic disease .
3. Participants with neuromuscular disorders .
Personalized Exercise Oncology

The Goal of the study is to identify trait-homogenous groups of cancer patients in regards to their physical activity associated health literacy. Based on these Groups, individualized exercise protocols and educative strategies can be developed which may increase the efficacy of the exercise therapy and increases the likelihood that patient get involved in physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed cancer diagnosis
* Females and males ≥18 years of age
* Undergoing either chemo-, immune-, radio- or anti-hormonal treatment
* Last surgery more than 6 weeks in the past
* Ability to understand English or German
* Be able to provide and understand informed consent
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Score of ≤ 2

Exclusion Criteria:

* Heart insufficiency \> NYHA III (New York Heart Association) or uncertain arrhythmia
* Uncontrolled hypertension
* Severe renal dysfunction (GFR \< 30%, Creatinine\> 3mg/dl)
* Reduced standing or walking
* Current pregnancy
* Any other evidence in the medical record of an absolute contraindication for exercise
Study of the Effectiveness of a Computer Decision Support System to Improve Physicians' Screening for Autism

The investigators hypothesize that children seen in a clinic that uses a compute based system known as CHICA, which reminds pediatricians to screen at defined time point for autism, will be screened more consistently for autism and receive more timely diagnostic a treatment services.

To be eligible for this trial, participants must receive their care at one of four primary care clinics in Indianapolis where the CHICA system is used.

Eligibility Criteria:
Inclusion Criteria:

* Previously healthy children receiving routine care in one of four clinics in Indianapolis who participate in this study.

Exclusion Criteria:

* Previously known autism spectrum disorders or other causes of developmental delay
Clearblue® Advanced Ovulation Test User Study

The Clearblue® Advanced Ovulation Test is designed for home use by women who are either planning or trying for a pregnancy.

The purpose of this protocol is to demonstrate that lay-users representative of the target user population are able to use the product in the intended user environment.

The Clearblue Advanced Ovulation Test is designed for home use by women who are trying to get pregnant now or in the near future. It identifies those days in a woman's cycle on which intercourse is most likely to lead to conception.

The product defines three phases of fertility through urine hormone measurement: Low (small chance of conceiving), High (increased chance of conceiving) which is achieved by the detection of a rise in the level of estrone-3-glucuronide and Peak (highest chance of conceiving) which provides an early warning of impending ovulation through detection of the luteinising hormone surge which precedes it by 24 - 36 hours.

This protocol aims to demonstrate the successful usage of the Clearblue Advanced Ovulation Test product by lay-users in the intended environment.

Elements of system usability, product satisfaction and ease of use will be used to assess overall product performance in lay-user hands.

Lay users will be required to user the product according to the instructions for use for a mimimum of 1 complete menstrual cycle after which they will be required to provide feedback on product use.

A usability scale which focusses on providing subjective feedback from users. This is a simple ten-item attitude Likert scale which each volunteer will complete after 4 weeks of product use. The primary endpoints of this study will focus on the use of this scoring scale to determine the usability of the product in lay-user hands.

Eligibility Criteria:
Inclusion Criteria:

Female Aged 18 to 45 years Trying to conceive, planning to conceive in the next year or interested in using an ovulation testing system.

Willing to provide written informed consent to participate in the study. Has menstrual cycles.

Exclusion Criteria:

Pregnant, recently pregnant or breastfeeding Diagnosed with Polycystic Ovarian Syndrome Use of hormonal contraception Use of hormone replacement therapy Use of any other medical treatment for fertility such as ovulation drugs, artificial insemination, assisted fertility such as IVF, ICSI Currently or previously employed by SPD, Alere, Unipath or P and G, or affiliates Has an immediate relative currently or previously employed by SPD, Alere, Unipath or P and G or affiliates

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A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.


Eligibility Criteria:
Inclusion Criteria:

* Male patients with severe congenital haemophilia A (FVIII activity level below 1%)
* Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII products for patients aged 6-11 years and above 50 ED to FVIII products for patients aged 0-5 years

Exclusion Criteria:

- Any history of FVIII inhibitors
A Study of the Pharmacokinetics and Safety of Varespladib in Subjects With Normal or Impaired Renal Function

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-lactating females 18 years or older with a BMI of 18-40 kg/m2 inclusive.
* Regarding renal function, subjects will be classified as either normal or as suffering from mild,moderate or severe renal impairment. Classification of renal impairment will be estimated by the MDRD and Cockcroft-Gault formulae

Exclusion Criteria:

* Any disease, condition and/or chronic medications which might compromise the hematologic, cardiovascular, pulmonary renal, gastrointestinal, hepatic, or central nervous system; or other conditions that might interfere with the distribution, metabolism or excretion of study drug, or would place the subject at increased risk
* Evidence of significant respiratory, gastrointestinal or hepatic disease at screening
* Positive screen for hepatitis B surface antigen, or HIV
* Positive test in drugs of abuse screens or alcohol on admission to the clinic
Neural Mechanisms of Sevoflurane Induced Anesthesia: an EEG fMRI Study in Healthy Volunteers

In imaging functional connectivity (FC) analyses of the resting brain, alterations of FC during unconsciousness have been reported. These results are in accordance to recent electroencephalographic studies observing impaired top-down processing during anesthesia. In this study, simultaneous records of functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) were performed to investigate the causality of neural mechanisms during sevoflurane anesthesia by correlating FC in fMRI and directional connectivity (DC) in electroencephalogram.


Eligibility Criteria:
Inclusion Criteria:

* ASA I
* male
* age \> 18y

Exclusion Criteria:

* drug abuse
* history of psychiatric or neurologic diseases
* amblyacousia, deafness
* contradictions to the study drug (sevoflurane)
* implants
* piercings, tatoos
Risk Prediction Model of Cardiovascular Events in Patients With Schizophrenia

Schizophrenia is a serious mental illness that has a great impact on social function. Studies have evidenced that schizophrenia patients live 10-20 years less than general population.It mainly dues to high cardiovascular risk. How to improve patients' survival rates? At present, there is an objective model to assess cardiovascular risk among schizoprenia patients in England - PRIMROSE.But there is a lack of model for schizophrenia patients in china. In order to better guide clinical practice, we are now exploring a domestic cardiovascular risk prediction model to raise people's awareness.

Schizophrenia is a common severe mental disorder with high rate of disability, which seriously affects patients' life.It is necessary to take long-term therapy to control symptoms or prevent recurrence. Studies have found that schizophrenia patients live on average ten to twenty-five years less than others. The main reason for high rates of mortality and disability is the high risk of cardiovascular events.There are few domestic large-scale studys on the risk of cardiovascular events in schizophrenia, thus they have not formed objective tools to assess cardiovascular risk. If this risk can be objectively assessed and predicted at an early stage, it is expected to reduce the risk of cardiovascular events and thus reduce mortality.At present, there are mature tools for assessing the risk of cardiovascular events in patients, such as Framingham, PRIMROSE, etc.The latter is the new tool for assessing cardiovascular events in patients with severe mental disorders. This study used a retrospective cohort design to collect the history of hospitalized schizophrenia patients within 2 years, collect relevant informations about cardiovascular events. The investigators validate the PRIMROSE model in China and explore the risk prediction model of cardiovascular events in schizophrenia patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized before July 1, 2020；and hospitalized between July 1 2020-June 30, 2022；
* Meeting the ICD-10 diagnostic criteria for "Schizophrenia, Schizotypy, delusional disorder"or ICD-11 diagnostic criteria for "Schizophrenia and other Primary Mental Disorders";
* At least 2 doctors in charge of ward make definitive diagnoses;
* Age ≥18 years old, male and female are not limited.

Exclusion Criteria:

* Researchers consider patients unsuitable for the study;
* past history of cardiovascular disease (fatal and nonfatal cardiovascular events defined as myocardial infarction, Angina, coronary heart disease, coronary artery surgery, cerebrovascular accident and transient ischemic attack, peripheral arterial disease or revascularization) prior to antipsychotic therapy ;
* use of lipid lowering drugs or antiplatelet drugs, such as aspirin、statins ，prior to antipsychotic therapy.
Study of Postprandial Incretin Response in Women With Gestational Diabetes

The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.

The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

The researchers investigated nineteen pregnant women in third trimester and again postpartum. At the experimental days we performed a mealtest and drew blood for analyses of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), insulin, C-peptide and glucagon.

The researchers aimed to investigate whether women with gestational diabetes mellitus exhibit decreased postprandial GLP-1 responses, and if so, whether this deficiency ceases following delivery when normal glucose tolerance is reestablished.

Eligibility Criteria:
Inclusion Criteria:

* Normal haemoblobin
* Willingness to participate

Exclusion Criteria:

* First degree relative with diabetes
* Diabetes before pregnancy
* Positive islet cell- and GAD-65 autoantibodies
Paclitaxel-Carboplatin Alone or With M2ES for Non-Small-Cell Lung Cancer

A phase II, multicenter, randomized, double-blind, placebo-controlled study was carried out. Patients were randomly assigned to the treatment (PC + pegylated endostatin) or the control group (PC+ placebo). The efficacy was evaluated every six weeks.Follow-up continued until disease progression or death.

A randomized phase 2 study, involving patients with advanced non-small-cell lung cancer who had not previously received chemotherapy, compared paclitaxel and carboplatin Plus placebo with paclitaxel and carboplatin plus PEGylated endostatin, with PEGylated endostatin at a dose of 10 mg/m2 intravenously every weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed, newly diagnosed stage IIIB or stage IV cancer or recurrent non-small-cell lung cancer for which they had not received chemotherapy, targeted therapy.
2. Prior radiation therapy was allowed provided that the only sites disease were not located in lung.
3. Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
4. ≥18 years of age.
5. ECOG performance status of 0 or 1.
6. Life expectancy of at least 12 weeks.
7. Adequate hematologic, hepatic, and renal function.
8. Patients are voluntary to participate and sigh the informed contents.

Exclusion Criteria:

1. Major surgery within the prior 4 weeks.
2. Participating any clinical trial within the prior 4 weeks.
3. Patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
4. Another active malignancy, or any history of other malignancy within the past 3 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix.
5. Pregnant or lactating women.
6. Radiation therapy have not been completed 4 weeks before enrollment.
7. Pulmonary embolus, deep venous thrombosis or bleeding diathesis.
8. Uncontrolled intercurrent illness as following: prior or ongoing uncontrolled hypertension;angina pectoris; congestive cardiac failure; myocardial ischemia, infarction, uncompensated coronary artery disease within the past 12 months; Uncontrolled arrhythmia; Uncontrolled diabetes mellitus; Uncontrolled infection.
9. Grade 2 hemoptysis within the past 6 months.
10. Acute or chronic renal disease.
11. Active hepatitis or HIV.
12. ECG: QTC ≥ 480 ms.
13. Patients on therapeutic doses of heparin.
14. Other conditions that are regarded for exclusion by the investigator.
Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation(SAPPHIRE Study)

We propose to establish a database characterizing the presence or absence of comorbid PTSD in veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with schizophrenia or SAD, this database will facilitate the investigation of a number of additional specific research questions relevant to veterans with psychotic disorders.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. 18-72 years of age, any ethnic group, either sex.
2. Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder.
3. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.

Exclusion Criteria:

1. Unstable current medical or neurological illness.
2. Significant suicidal or homicidal ideation.
3. Pregnant women or women who could be pregnant.