cyrilzakka/clinical-trials huggingface dataset:
Core Stability Measures as a Risk Factor for the Development of Lower Extremity Injuries in Physical Education Students

Male and female physical education students were subjected to a clinical test battery comprised of valid and reliable tests to measure different aspects of core stability at the start of the study. After a period of 2 months testing, the injury registration procedure started with the use of an online injury registration platform and regular call back moments. After 2 years of injury registration, all data was gathered and will be analysed statistically to link the measured core stability aspects as risk factors for certain lower extremity injuries.

September 2014 - December 2014: 139 male and female participants 18+ were subjected to different test to evaluate corresponding aspects of core stability. The following test were performed: Star excursion balance test; Lumbopelvic proprioception test; Lumbopelvic neuromuscular control test; Lateral step down test; Hip strength test measured with a handheld dynamometer(flexion/extension/abduction/adduction/internal rotation/external rotation); Trunk strength tests measured with a handheld dynamometer (trunk flexion and trunk extension) and core muscle endurance tests (prone bridging test/Biering-Sorenson test/side bridging tests).

January 2015 - April 2017: Prospective follow up of lower extremity injury contracted during sports activity. The injuries were confirmed by a medical examiner and were recorded in an online injury registry platform (Survey Monkey).

Statistical analysis will be performed to evaluate which core stability outcome measure can be considered a risk factor for the development of lower extremity injuries.

Eligibility Criteria:
Inclusion Criteria:

- 1st year of physical education study (enrolled at the Artevelde graduate school or the Ghent graduate school

Exclusion Criteria:

* Musculoskeletal injury at the time of study participation
* Pre-existing lower back injury
* Pre-existing lower extremity injury (less than 6 months prior to study participation)
Molecular Biomarkers Predicting Early Development of Endometrial Carcinoma

Endometrial carcinoma represents the most common gynaecological cancer and the sixth most frequent cancer among women worldwide. The 5-year survival of patients with stage I endometrial carcinoma is 75%-88% versus 50% for stage III or 15% for stage IV disease. Therefore, early detection could improve survival rates. Specifically, in the most prevalent, type 1 endometrial cancer develops from hyperplastic endometrium. The aim of the study was to evaluate the utility of cancer gene mutations from endometrial biopsies towards predicting synchronous or metachronous development of malignant lesions. The aim of the study was to evaluate whether endometrial biopsies could already carry mutations in cancer genes useful for predicting or anticipating subsequent cancer development


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* patients subjected to endometrial biopsies with previous histopathologically negative and subsequent histopathologically positive for endometrial carcinoma
* patient informed consent

Exclusion Criteria:

- Endometrial carcinoma patients without a previous non-tumour biopsy were excluded
DOTr/DOTa Algorithm Guidance for Refractory Solid Tumors

This study is an open, single center clinical study targeting solid tumor patients who have exhausted or cannot tolerate standard treatment regimens. The main purpose of this study is to investigate the feasibility, efficacy, and safety of selecting treatment regimens based on DOTr/DOTa results for solid tumor patients who have exhausted or cannot tolerate standard treatment regimens.

Both OncoTarget(DarwinOncoTargetTM (DOTa)), which identifies high-affinity inhibitors of individual master regulator (MR) proteins, and OncoTreat(DarwinOncoTreatTM (DOTr)), which identifies drugs that invert the transcriptional activity of hyperconnected MR modules, produced highly significant 30-day disease control rates (68% and 91%, respectively).

Eligibility Criteria:
Inclusion Criteria:

1. The subjects must be able to understand the procedures and methods of this study, be willing to strictly follow the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form;
2. Patients aged ≥ 18 years old;
3. Solid tumor patients who are depleted of standard treatment or unable to tolerate standard treatment regimens;
4. According to the RECIST solid tumor efficacy evaluation criteria, there should be at least one measurable lesion;
5. ECOG PS score 0-4 (3-4 score only for patients caused by tumor);
6. The expected survival period is not less than 12 weeks;
7. Women of childbearing age must have a Pregnancy test (serum) within 7 days before enrollment, and the result is negative, and are willing to use appropriate methods of contraception during the test period and within 8 weeks after the last administration of the test drug;
8. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up;
9. If the main organs function normally, they meet the following standards:

The blood routine examination standard must comply with (no blood transfusion or blood products within 14 days, no correction using G-CSF or other hematopoietic stimulating factors): Hb ≥ 90g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L;Biochemical examination must meet the following standards: TBIL ≤ 1 × ULN; ALT, AST ≤ 1.5 × ULN; ALP ≤ 2.5 × ULN; BUN and Cr ≤ 1.5 × ULN; Color Doppler echocardiography: left ventricular Ejection fraction (LVEF) ≥ 50%.

Exclusion Criteria:

1. Severe heart disease or discomfort that cannot be treated;
2. Those who suffer from mental illness or abuse of psychotropic substances and are unable to cooperate;
3. Pregnant or lactating female patients;
4. Participating in other clinical trials at the same time;
5. Researchers believe that individuals are not suitable for enrollment.
PK of Depo SubQ Injected in the Upper Arm

A single-arm trial to demonstrate that Depo-SubQ Provera injected in the upper arm is adequate for effective contraception

A single-arm trial to demonstrate that the blood levels of medroxyprogesterone acetate are adequate for effective contraception when Depo-SubQ Provera 104 is injected in the upper arm

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40
* negative pregnancy test on day of injection
* not wishing to become pregnant in the next 12 months
* at negligible risk of pregnancy (e.g. sterilized, in exclusively same-gender partnership, in a monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD)
* body mass index of 18-30

Exclusion Criteria:

-
Investigating the Relationship Between Triglycerides and Fetal Overgrowth in Gestational Diabetes

This is a prospective, observational study which examines the association between maternal triglycerides in the antepartum period and fetal overgrowth in pregnancies complicated by gestational diabetes. Mothers are asked to provide 2 blood samples, undergo fingerstick blood measurements, and to have their newborns measured for body fat composition in the first 6 months of life.

Gestational diabetes (GDM) is a condition of impaired insulin resistance which causes increased morbidity for mothers and newborns due to fetal overgrowth. Traditionally, GDM is diagnosed with a glucose tolerance test, and treatment subsequently focuses singularly on glucose management. However, both glucose and triglycerides (TAG) are fuels for fetal overgrowth. The central hypothesis is that the most effective understanding of fetal overgrowth needs to include both carbohydrates and triglycerides. The study will focus recruitment on patients who have GDM and BMI \> 35. The specific aims are 1) Determine the relationship between TAG levels during pregnancy and offspring size, 2) Explore the relationship between TAG levels during pregnancy and adipose tissue accrual (birth weight, body composition and adipose tissue distribution) from birth to six months old, and 3)Examine the relationship between maternal TAG levels and cord c-peptide levels. Mothers are asked to check their serum triglycerides at the time of diagnosis of GDM and at the end of pregnancy. Fingerstick blood measurements of triglycerides are also measured every 2 weeks at prenatal visits. At delivery, cord blood is collected. Infants are examined at 0.5, 3, and 6 months after birth.

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* diagnosis of GDM between 24-32 weeks
* BMI \>= 30

Exclusion Criteria:

* Conditions known to impact fetal growth.These conditions can develop after study enrollment but cannot be present at enrollment.
* autoimmune conditions treated with medication
* chronic hypertension requiring medication
* preeclampsia
* fetal growth restriction diagnosis
* smoking
* illicit drug use
* major fetal anomalies
* fetal genetic conditions
Clinical Study of Neoantigen Vaccine Combined With Targeted Drugs in the Treatment of Non-small Cell Lung Cancer

Neoantigen vaccine is a new field of research in tumor immunotherapy, and some studies have been conducted with success on Melanoma and glioblastoma. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV) and EGFR mutant non-small cell lung cancer will be resistant after targeted drug treatment. Neoantigen vaccine is a new treatment method for lung cancer, especially for patients with drug resistance.

This is a phase I clinical study of individualized neoantigen peptide vaccine combined with targeted drugs in the treatment of EGFR mutant non-small cell lung cancer aimed to evaluated the safety and immune response of the neoantigen vaccine treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed locally advanced or metastatic non-small-cell lung cancer (stage III or stage IV).
2. With EGFR-TKI sensitive mutations and no T790M.
3. First generation EGFR-TKI treatment is in progress, the treatment time is 5-6 months and there is no disease progression.
4. Patients aged 18 to 85
5. Life expectancy of at least 3 months.
6. ECOG Performance Status 0 to 3.
7. No previous immunotherapy, including anti-PD-1/PD-L1 or co-suppressive T cell receptor drug therapy, peptide / mRNA neoantigen immunotherapy and cell therapy.
8. Ability to follow research and follow-up procedures. Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion Criteria:

1. Pregnant and/or breastfeeding.
2. With active, known or suspected autoimmune diseases or other concurrent immune system diseases.
3. Receive systemic cytotoxic chemotherapy or experimental drugs within 4 weeks before the start of neoantigen treatment, excluding EGFR-TKI and anti-angiogenesis targeted drugs.
4. Patients participated in other anticancer drug clinical trials within 4 weeks.
5. Liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and impaired hematopoietic function.
6. Systemic infection.
7. Any uncertainties that have an impact on the safety or compliance of the patient.
8. Any disease, treatment, abnormal laboratory history or medical history that affects the participant's participation in the entire research process, or the investigator believes that it is not suitable to participate in this study.
Customized PRK With Mitomycin Versus Customized Lasik for Myopic Astigmatism

The present study was designed to compare the use of mitomycin in PRK for the treatment of refractive errors and to compare these results to customized Lasik


Eligibility Criteria:
Inclusion Criteria:

* Myopia or compound myopic astigmatism, stable refractive error, no associated eye disease

Exclusion Criteria:

* Diabetes, autoimmune diseases, topographic abnormalities
COVID-19 Associated With Psoriasis

A retrospective analysis based on database was conducted to evaluate the correlation between covid-19 infection and the condition and treatment of psoriasis patients.

Based on the patients registered in the psoriasis patient database of each center, the patients were followed up by telephone, and the severity of covid-19 infection, the change of psoriasis condition and the adjustment of treatment methods of psoriasis patients were collected for retrospective analysis.

Eligibility Criteria:
Inclusion criteria ----

1. No age limit, both male and female are accepted;
2. Psoriasis patients registered in the database;
3. Patients or their families can cooperate to complete the follow-up information survey (questionnaire, telephone, etc.) independently, and ensure the authenticity of the data provided.

Exclusion criteria ----

Patients are thought having conditions which are not appropriated for attending this clinical trial.
Cervical Traction, Passive Accessory Intervertebral Movements and Active Strength Training in Cervical Radiculopathy

To determine the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy. To compare the effectiveness of Manual Cervical Traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active strength training in the management of cervical radiculopathy.

Cervical radiculopathy is a clinical condition resulting from compression of cervical nerve roots near the spinal cord. Some factors that may increase the risk for developing cervical radiculopathy include age. The risk for cervical radiculopathy tends to increase with age. This study is based on three interventions (Manual Cervical traction, Passive Accessory Intervertebral Movements (PAIVMs) and Active Strength Training) individually on three separate but equal groups of participants. It will determine the most effective intervention and which intervention is superior to the other for treating cervical radiculopathy and to assist future practitioners and researchers.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cervical radiculopathy due to muscle tightness or spasm (Diagnosed by Spurling's Test)
* Having complaint more than 2 months

Exclusion Criteria:

* Past history of cervical surgery
* Past history of cervical trauma
* Any inflammatory disease
* Tumor or Carcinoma
* Disco genic/ disc herniation or stenosis cause of radiculopathy.
A Study to Compare the Effect of ASP3550 With Goserelin in Patients With Prostate Cancer

To compare the efficacy and safety of ASP3550 to goserelin acetate in patients with prostate cancer.

This study consists of two parts. The purpose of PART 1 is to test non-inferiority of ASP3550 to goserelin acetate with respect to the cumulative castration rate in terms of serum testosterone when ASP3550 or goserelin acetate is administered for one-year in patients with prostate cancer.

The patients assigned to receive ASP3550 and completed the treatment in PART 1 are eligible for the treatment in PART 2, and will receive ASP3550 maintenance dose subcutaneously for additional term. The long-term safety, efficacy and PK of the continued ASP3550 treatment will be assessed in PART 2.

Eligibility Criteria:
Inclusion Criteria:

* Male patient with histologically confirmed prostate cancer (adenocarcinoma).
* Patient in whom endocrine treatment is indicated. Patient having undergoing prostatectomy or radiotherapy with curative intention and has a rising serum PSA (PSA ≥ 2 ng/mL at screening) may be included.
* Has a serum testosterone level above 2.2 ng/mL at screening.
* Has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2 at screening.
* Has a serum PSA ≥ 2 ng/mL at screening.
* Has a life expectancy of at least 12 months.

Exclusion Criteria:

* Previous or present endocrine treatment for prostate cancer. Example: surgical castration, GnRH agonists, GnRH antagonists, antiandrogens or oestrogens, and 5α-reductase inhibitors.
* Received a 5α-reductase inhibitor within 25 weeks preceding screening.
* Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months.
* Has concurrent or a history of poorly controlled severe asthma, anaphylactic reactions, severe urticaria or angioedema.
* Has hypersensitivity towards mannitol.
* Has a marked prolongation of QT/QTc interval (two consecutive increases to \>450 ms in QTc interval at retest) at screening.
* Has concurrent or a history of a disease (heart failure, hypokalemia, a family history of QT prolongation syndrome, etc.) that may induce Torsade de Pointes.
Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily \[QD\]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.

Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:

* current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
* no diagnosis of HeFH and receiving intensive lipid-lowering therapy
* no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.

Eligibility Criteria:
Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism
BioWare for AUD and PTSD

This study examines the ability of an innovative telehealth technology system to enhance Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure (COPE) talk-therapy for individuals with posttraumatic stress disorder (PTSD) and alcohol use disorder.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female; aged 18-70 years.
2. Able to provide written informed consent.
3. Meet DSM-5 diagnostic criteria for current moderate to severe alcohol use disorder.
4. Meet DSM-5 diagnostic criteria for current PTSD.
5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation.

Exclusion Criteria:

1. Meet DSM-5 criteria for a history of or current psychotic or bipolar disorders.
2. Current suicidal or homicidal ideation and intent.
3. Psychotropic medications which have been initiated during the past 4 weeks.
4. Acute alcohol withdrawal.
5. Pregnancy or breastfeeding for people of childbearing potential.
6. Currently enrolled in evidence based behavioral treatment for AUD or PTSD.
7. Implanted electronic devices of any kind, including pacemakers, electronic infusion pumps, stimulators, defibrillators or similar.
Perioperative Fluid Therapy in Patients Undergoing Pancreaticoduodenectomy

Postoperative complication rates in patients undergoing pancreaticoduodenectomy remain high although the operation techniques have developed a lot in recent years. There is evidence that restrictive intraoperative fluid therapy could decrease postoperative complication rates but the results of the former studies have been somewhat controversial. The aim of this study is to examine whether the intraoperative and postoperative fluid therapy affect to the postoperative complication rates in patients undergoing pancreaticoduodenectomy.

The study is a retrospective cohort study. The first cohort consists of patients who underwent pancreaticoduodenectomy in year 2015 when intraoperative fluid therapy were managed using goal directed fluid therapy technique. The second cohort consists of patients who underwent pancreaticoduodenectomy in year 2017 when intraoperative fluid therapy were based on the consideration of the anaesthesiologist. In 2015 most of the patients spent the first postoperative night in the ICU where the fluid management and monitoring of the urine output and vital functions were more controlled than in the normal ward. In 2017 most of the patients got in the regular ward right after the surgery. The aim of the study is to examine whether there are differences in the amounts of the intraoperative and postoperative fluids between the cohorts and does the perioperative fluid therapy affect to the complication rates.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or over
* patients who underwent pancreaticoduodenectomy in 2015 or in 2017

Exclusion Criteria:

* patients whose patient record information is insufficient
Bioavailability Study of ODM-201 in Subjects With Metastatic Chemotherapy-naive Castration-resistant Prostate Cancer

A study to investigate which of two different tablet formulations of ODM-201 is best suited for use in the further development of the compound in the treatment of metastatic chemotherapy-naive castration-resistant prostate cancer. Patients successfully completing the bioavailability study will be able to receive further treatment with the current capsule formulation of ODM-201 until progression of their disease with the safety and tolerability of ODM-201 being assessed throughout.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent (IC) obtained.
* Histologically confirmed adenocarcinoma of prostate
* Progressive metastatic disease
* Ongoing androgen deprivation therapy with a luteinising hormone-releasing hormone (LHRH) analogue or antagonist or bilateral orchiectomy
* Adequate bone marrow, hepatic and renal function
* Able to swallow the ODM-201 whole as a capsule or tablet.

Exclusion Criteria:

* Previous chemotherapy for prostate cancer.
* Known metastases in the brain.
* History of other malignancy within the previous 5 years, except a basal cell carcinoma of skin.
* Known gastrointestinal condition that can significantly affect the absorption of the study treatment.