cyrilzakka/clinical-trials huggingface dataset:
Study of REGN4018 Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers

The main purpose of this study is to:

* Learn about the safety of REGN4018 and to find out what dose of REGN4018 can be given alone or with cemiplimab to patients with ovarian cancer or cancer of the uterus
* The study will also look at the levels of REGN4018 and/or cemiplimab in your body and measure how well your body can remove the study drug(s). This is called pharmacokinetics
* The study will also look at any signs that REGN4018 alone or with cemiplimab can treat recurrent advanced ovarian cancer or cancer of the uterus
* To find out how safe and tolerable the sarilumab pretreatment is, in combination with REGN4018 and cemiplimab


Eligibility Criteria:
Key Inclusion Criteria:

1. Ovarian Cancer Cohorts Only: Patients with histologically or cytologically confirmed diagnosis of advanced, epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer who have all of the following:

   1. serum CA-125 level ≥2 x upper limit of normal (ULN) (in screening)
   2. has received at least 1 line of platinum-containing therapy or must be platinum-intolerant (applicable for dose escalation and non-randomized dose expansion cohorts)
   3. documented relapse or progression on or after the most recent line of therapy
   4. no standard therapy options likely to convey clinical benefit
2. Adequate organ and bone marrow function as defined in the protocol
3. Life expectancy of at least 3 months
4. Randomized phase 2 expansion cohort (Ovarian Cancer only): Platinum-resistant ovarian cancer patients who have had 1 to 3 lines of platinum-based therapy as defined in the protocol.
5. Endometrial Cancer Cohorts Only: histologically confirmed endometrial cancer that has progressed or recurrent after prior anti-Programmed Cell Death Ligand 1 (PD-1) therapy and platinum-based chemotherapy:

   1. MUC16 positivity of tumor cells ≥25% by immunohistochemistry (IHC)
   2. 1-2 prior lines of systemic therapy

Key Exclusion Criteria:

1. Prior treatment with anti-Programmed Cell Death (PD-1)/PD-L1 therapy, as described in the protocol
2. Ovarian Cancer Expansion cohorts only: More than 4 prior lines of cytotoxic chemotherapy
3. Prior treatment with a MUC16 - targeted therapy
4. Untreated or active primary brain tumor, central nervous system (CNS) metastases, or spinal cord compression, as described in the protocol
5. History and/or current cardiovascular disease, as defined in the protocol
6. Severe and/or uncontrolled hypertension at screening. Patients taking anti-hypertensive medication must be on a stable anti-hypertensive regimen

Note: Other protocol Inclusion/Exclusion Criteria apply
CBT to Treat Depression in Renal Patients

The purpose of this study is to determine whether Cognitive Behavioral Therapy is effective in the treatment of depression in patients with end-stage renal disease in hemodialysis therapy

Depression is a persistent problem among patients with end-stage renal disease and it does not tend to improve over time. The implementation of effective interventions to treat and prevent recurrence of depressive episodes is needed. The objectives of this study are: 1)the detection of Major Depression in hemodialysis patients; 2)to allocate patients with depression in two groups: structured program of treatment with CBT (group therapy)and control group (conventional psychotherapy at the dialysis unit); and 3)to verify whether after 3 months of CBT there was a remission of depressive symptoms and a improvement of the quality of life in the CBT group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Chronic renal disease (end stage) in hemodialysis for at least 3 months
* Diagnosis of Major depression disorder (4 or more clinical criteria in MINI and a BDI score of 10 or more)

Exclusion Criteria:

* Patients in process of renal transplant with (living donor)
* Psychiatric comorbidity
* Cognitive impairment or mental retardation
* Current substance abuse
* Heart failure, angina pectoris, arrhythmias
The Influence of Central and Peripheral Fatigue on Sports Performance and Prevention of Sports Injury

This is an observational study that assess the baseball pitchers' fatigue status. The purpose of this study is to find the pitching mechanic change and the fatigue point to provide guidance for coaches to schedule training items . It is expected that earlier detect the pitchers' fatigue point could be able to prevent overuse injury caused by compensatory actions.

The expected outcomes of this study include providing more reliable scientific evidence of the effects of fatigue on baseball players' performance and movement control, which can help to improve muscle endurance and the quality of movement control. Moreover, fatigue that resulted from the prolonged practice can be reduced and recovered faster after exercise, as well as more understanding on the ideal pitching posture and compensatory action that caused by fatigue, providing a guideline for exercise training. This will not only help to prevent fatigue and reduce risk of injury, but also strengthen weak muscle groups and improve movement strategies before matches, as well as lengthen the time of being a baseball player.

Eligibility Criteria:
Inclusion Criteria:

* healthy baseball pitchers
* age between 18\~35 years old

Exclusion Criteria:

* surgery history in pitching arm
* Musculoskeletal disease
* Neuromuscular disease
ICare Self-tonometry - A Head-to-head Comparison to the Gold Standard Goldmann Tonometer

The purpose of this study is to compare glaucoma patients' own I Care measurements by the standard Goldmann applanation tonometer intraocular pressure (IOP) measurements.

not necessary

Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension (OHT):with/without glaucoma drugs
* Primary open angle glaucoma (POAG)- high pressure: Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg.
* Primary open angle glaucoma, normal pressure: cfr high pressure but intraocular pressure ≤ 21 mmHg
* Exfoliative Glaucoma (PEX): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg, with exfoliation material in the anterior segment.
* Pigmentary Glaucoma (PDG): Diagnosis based on optic nerve head rim loss and/or visual field defects and intraocular pressure (IOP) \>21 mmHg, with Krukenberg's spindle and/or pigment dispersed on the trabecular meshwork.

Exclusion Criteria:

* Age \<18 years
* Other glaucoma types
* Corneal pathology (edema, dystrophia, corneal transplantation, severe keratoconus, permanent contact lens wear, recurrent corneal erosion)
* Severe arthritis (unable to handle home i care device)
* Lack of comprehension
* Intra ocular surgery and laser treatment during the last 6 months
C15:0 Supplementation in Young Adults at Risk for Metabolic Syndrome

This study will determine changes in plasma C15:0 levels in young adults with BMI ≥ 25 in response to 12 weeks of daily oral C15:0 supplementation.

Metabolic syndrome is a disturbance in how the body processes both carbohydrates and fats. This condition has become common in children and young adults, especially in association with excess body fat. People with metabolic syndrome are at increased risk for type 2 diabetes, cardiovascular disease, and nonalcoholic fatty liver disease (NAFLD). Diet is believed to play an important role in both developing and treating metabolic syndrome. Studies have shown that low dietary intake of a type of fats known as odd chain fatty acids is associated with a higher risk for each of the metabolic syndrome associated conditions of diabetes, heart disease, and liver disease. Supplementation with one specific odd chain fatty acid known as C15:0 has shown to decrease the effects of metabolic syndrome in both cellular and animal models. In people, the epidemiology of consumption of C15:0 in the diet is consistent with this belief. However, clinical trials have yet to be done with supplemental C15:0. This study is a pilot study of C15:0 supplementation in a group of young adults at risk for metabolic syndrome. The study will determine how well supplementation with C15:0 daily for 12 weeks is able to raise levels of C15:0 in the blood when compared to placebo. The study will also look for signs that increasing blood levels of C15:0 leads to changes in physiology.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 through 25 years
* Body Mass Index ≥ 25 Kg/m2

Exclusion Criteria:

* Reported habitual dietary intake of C15:0 that consistently exceeds 250 mg per day
* Significant alcohol consumption (average consumption \>1 drink/day for females, \>2 drink/day for males or episodes of binge drinking \>5 drinks/day)
* Inability to swallow capsules
* Type 1 or Type 2 Diabetes
* Liver Cirrhosis
* Pregnancy
* Body weight greater than 125 kg at screening
* LDL-cholesterol \> 160 mg/dL
* Triglycerides \> 500 mg/dL
* Hemoglobin \< 10.0 gm/dL
* Current Omega 3 Fatty Acid supplement usage
* Current use of Statin medications
* Any other condition which, in the opinion of the investigator, would impede compliance or hinder completion of the study
* Patients who are currently enrolled in a clinical trial or who received an investigational study drug within 180 days of screening.
* Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator.
* Failure to give informed consent
Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors

This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors.

This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification sunitinib 50mg will be administered orally once a day 42 days.Study treatment will be continued until objective disease progression.

To investigate the efficacy of sunitinib in subjects with Refractory solid tumors harboring RET fusion positive or FGFR2 Amplification.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of fully informed consent prior to any study specific procedures.
2. Patients must be ≥20 years of age.
3. RET fusion positive,FGFR amplification, Refractory Solid Tumors that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.
4. ECOG performance status 0-2.
5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
6. Adequate Organ Function Laboratory Values

   * Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 75 x 109/L
   * bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
   * creatinine ≤1.5 x UNL
7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
8. Adequate heart function.

Exclusion Criteria:

1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
2. Has known active central nervous system (CNS) metastases.
3. Has an active infection requiring systemic therapy.
4. Pregnancy or breast feeding
5. Patients with cardiac problem.
6. Any previous treatment with sunitinib
The Effect of Music Therapy on Comfort, Pain and Anxiety

Objectives: This study was conducted to determine the effect of music therapy on the pain, anxiety, and comfort levels of patients who underwent bone marrow aspiration and biopsy.

Methods: This research was conducted as a randomized controlled study in the hematology polyclinic of a university hospital. Music therapy will used with the intervention group throughout the procedure. During data evaluation, paired t-test, independent t-test and effect size will used. The sample group was calculated based on the sample groups of other studies in the literature (Çelebi et al., 2020; Özdemir et al., 2019). According to the preliminary power analysis results using the G.Power 3.1.9 program, the sample size was calculated at 80% power, at medium effect size at 5% alpha value. According to the analysis results, the sample size per group was calculated as 30. However, since there was 10% probability that some patients may drop, the sample size for the study was recalculated as 66 (Experimental Group: 33, Control Group: 33).The patients will informed about using music. In addition, it will explained that they could adjust the sound levels and that they should report when they are disturbed by the tone. Music continued throughout the process. Communication with the patient will maintained, and symptoms such as discomfort, anxiety were observed throughout the procedure. The music player will switched off after the procedure was completed. The patients will asked whether they had any discomfort while the music played. TThe music therapy will last an average of 30 minutes. After completing the procedures, the patient's pain, comfort, and anxiety levels were re-evaluated using VAS and STAI.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hematological malignancy (defined as multiple myeloma, Chronic Lymphocytic Leukaemia, Myelodysplastic syndrome or indolent lymphoma)
* 18 years of age or older,
* Must be able to speak Turkish

Exclusion Criteria:

* Hearing impairment
* hormonal dysfunction (adrenal, pituitary, thyroid, etc.)
* Sever anxiety disorder
* Parkinson's disease
* Alzheimer's disease
* Dementia
* Major depression
Effects of Walkasins on Gait Speed of Individuals With Mild Cognitive Impairments

The primary aim of this pilot study is to investigate the effect of Walkasins, a wearable lower-limb sensory prosthesis, on the gait speed and balance function of participants with mild cognitive impairment as measured by the Saint Louis University Mental Status (SLUMS) Examination.

The Walkasins system is one of a growing number of wearable devices that use various modalities of neuromodulation, defined as "the alteration of nerve activity through targeted delivery of a stimulus . . . to specific neurological sites in the body" (https://www.neuromodulation.com/). Because these technologies are relatively new, innovative applications of their use in various patient populations may lead to improvements in the care and quality of life of individuals who suffer from these life-altering diagnoses.

Previous studies of Walkasins have shown that individuals with peripheral neuropathy who have gait and balance problems walk faster with the Walkasins device. This increase may be related to an improved automaticity of gait function, which decreases the need for cognitive attention to the walking task, which is known to slow down gait. Individuals with mild cognitive impairment commonly show slow gait speeds, likely due to a decline in executive function. There is a reason to think that sensory stimuli from the Walkasins device can improve the automaticity of gait in these individuals and thereby enhance gait speed.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory person who is at least 65 years of age
* Ability to understand and provide informed consent
* Ability to perceive vibrations from the Walkasins Haptic Module
* Ability to complete the functional outcome measures without the use of an assistive device
* Foot size that allows the Walkasins to function appropriately
* Mild Cognitive Impairment (MCI) as measured by the Saint Louis University Mental Status (SLUMS) Exam (scores between 20 and 24 + or -2 for those with less than a high school education and scores between 21-26 + or -2 for those who graduated from high school, which indicate mild cognitive impairment) and/or a diagnosis of MCI (or related term) in the person's medical record
* Slow gait speed (\<1m/second or slightly faster, provided all other criteria are met)

Exclusion Criteria:

* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins
* Self-reported acute thrombophlebitis including deep vein thrombosis
* Untreated lymphedema
* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use
* Untreated fractures in the foot and ankle
* Self-reported severe peripheral vascular disease
* Other neurological conditions that impact walking (e.g., peripheral neuropathy)
* Weighs more than 300 pounds
Immobilization Versus Observation in Children With Toddler's Fractures: a Prospective Randomized Controlled Trial

Toddler's fractures of the tibia are by definition non-displaced and of a stable pattern. Children have thickened periosteum compared with adults, which therefore may impart stability to the fracture without the need for additional immobilization. The goal of the study is to evaluate whether or not there is a difference in children treated with and without cast immobilization in regards to time to ambulation; perceived pain; difficulty in dressing \& bathing; radiographic displacement or angulation; and time missed from work or daycare. Our null hypothesis is that there will be no difference in clinical or radiographic outcomes between the groups.


Eligibility Criteria:
Inclusion Criteria:

* • Children ages 1-5 years old with radiographic evidence of a non-displaced spiral or oblique fracture of the tibial shaft or metaphysis.

Exclusion Criteria:

* • Children with clinical suspicion but lack of radiographic evidence for toddler's fracture

  * Fractures displaced \>2mm
  * Open fractures
  * Pathologic fracture
  * Fractures involving the physis
  * Previous fracture of the ipsilateral extremity
  * Concomitant fracture involving the ipsilateral or contralateral leg
  * Concomitant head injury
  * Non-ambulatory children (i.e., those who have not yet begun to walk)
  * Children with bone-metabolism disorders (i.e., osteogenesis imperfect, rickets)
  * Children who are geographically prohibited from following up in our system
  * Children whose caregivers are not proficient in English
  * Presentation \>7 days from injury
  * Cases considered to be non-accidental trauma
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of SV001 in Chinese Healthy Adult Volunteers.

The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must fully understand the purpose, characteristics, methods and possible adverse reactions of the trial, volunteer as a subject, and sign the Informed Consent Form;
2. Subjects must have a Body Mass Index in the range of 19\~26 kg/m2, with males weighted not less than 50 kg, and females weighted not less than 45 kg;
3. Subjects must be in good health as judged by the investigator.
4. Reliable contraception must be assured during and for some time after the trial.

Exclusion Criteria:

1. Subjects with a history of drug or other substance anaphylaxis;
2. Subjects with respiratory symptoms or abnormal respiratory tract;
3. Subjects currently having an oral disease that the investigator judged may affect use of the trial drug and devices;
4. Subjects with other diseases or factors with abnormal clinical manifestations;
5. Subjects having a history of drug abuse in the past or having used narcotics in the period prior to screening, or having a positive result in urine narcotics test at baseline period;
6. Subjects who smoked more than 5 cigarettes a day in the period before screening;
7. Subjects who consumed more than 14 units of alcohol per week in the period prior to screening, or who is positive in breath alcohol test at baseline period;
8. Subjects who have suffered a clinically significant severe disease or undergone major surgical operations within a certain period of time prior to receiving the investigational drug, or who are expected to require major operations during the clinical trial;
9. Subjects who used other drugs within a certain period of time before receiving the investigational drug;
10. Screening period: FEV1≤80% predicted value or FVC≤80% predicted value;
11. Subjects who have antibody positive for Human Immunodeficiency Virus, Hepatitis B surface antigen, Hepatitis C or Treponema Pallidum.
12. Subjects who have difficulty in venous blood collection or have a history of acupuncture syncope and blood phobia;
13. Female subjects who are tested positive for pregnancy during the screening or baseline period or are in lactation period;
14. Subjects who have participated in other drug clinical trials and used other drugs in clinical trials within a certain period of time before receiving the investigational drug;
15. Subjects who have a history of blood donation or blood loss of more than 400 mL in the period prior to screening;
16. Any other status in which the investigator deems inappropriate to participate in the present study.
A Study of HS-20094 in T2DM Participants

This is a randomized, placebo and active-control, multiple-dose, phase IIa trial. Patients were randomly assigned to receive HS-20094 (12 patients), placebo (3 patients), or active control drug Semaglutide injection (3 patients) in a 4:1:1 ratio to each of four dose cohorts of 5 mg, 10 mg, 15 mg, and 20 mg. HS-20094 and placebo were administered in a double-blind design by subcutaneous injection once a week for a total of four times, and the dose was gradually increased weekly (2.5-2.5-5-5 mg, 5-510-10 mg, 5-10-15-15 mg, 5-10-15-20 mg). The active control drug semaglutide was administered by open-label, titrated subcutaneous injection once a week for a total of four times, and the dose was increased gradually every week until 1.0 mg (0.25-0.5-0.5-1.0 mg). The primary study objective was to 1) Evaluate the safety and tolerability of multiple subcutaneous injections of HS-20094 in subjects with type 2 diabetes mellitus (T2DM) with or without overweight or obesity;2) Evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of multiple subcutaneous injections of HS-20094.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects,20-65 years of age at the time of signing informed consent.
* Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit.
* Treated with conventional lifestyle intervention and stable treatment with metformin ( ≥ 1000 mg/day) at least 3 months prior to screening HbA1c 7.5-10%(both inclusive)at screening visit.

Exclusion Criteria:

* A history of type 1 diabetes, specific diabetes, or secondary diabetes.
* Presence of-clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit.
* Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening.
* A history of grade 2 hypoglycemia(blood glucose 3.0 mmol/L)or grade 3 hypoglycemia(hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery)within 6 months before screening.
* Diabetid ketoacidosis or hyperosmolar coma or lactic acidosis requiring hospitalization occurred within 6 months before screening.
* Severe infection such as diabetic foot infection, pneumonia, or sepsis within 30 days before screening.
* Uncontrollable hypertension.
* History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening.
* Any organ-system malignancies developed within 5 years except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
* Pregnant or lactating woman.
* In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.