cyrilzakka/clinical-trials huggingface dataset:
Acute Effects of Cryotherapy Duration in Healthy Individuals

The study will investigate the acute effects of cryotherapy duration on shoulder muscle strength, flexibility, endurance and dynamic balance in healthy individuals.

Cryotherapy is a practice that induces therapeutic effects by reducing tissue temperature to produce an analgesic effect. Cryotherapy application methods vary from simple ice packs and cold water immersion to whole body cryotherapy methods. The purpose of cryotherapy treatment is to reduce tissue damage, muscle spasm, edema and pain and to provide a faster rehabilitation process after injury. It is also used as a recovery technique after high-intensity training in different sports branches. Despite the proven benefits of cryotherapy according to the literature, discussions continue about its effect on some parameters and there is no consensus on the duration of cryotherapy application. In addition, although there are studies on the effects of cryotherapy on the lower extremities, studies for the upper extremity are limited and the results of these studies are inconsistent. In the literature, no study was found that evaluated the effect of cryotherapy application time on shoulder muscle strength, endurance, flexibility and balance. Therefore, in this study, the acute effects of cryotherapy duration on shoulder muscle strength, flexibility, endurance and dynamic balance in healthy individuals will be investigated and the optimum duration of cryotherapy on these parameters will be determined. In addition, the results of the research will contribute to the planned rehabilitation and exercise program.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-25 who volunteer to participate in the study
* No upper extremity orthopedic problems
* No history of shoulder injury or surgery in the past two years
* Absence of Raynaud's disease or cold intolerance

Exclusion Criteria:

* Having a history of shoulder injury or surgery
* Cervical or thoracic spine disorders
* People with any neurological disorder or known balance/proprioceptive deficits
* Decreased sensation or decreased blood flow
* Have Raynaud's disease or any cold intolerance
IMA402 T Cell-Engaging Receptor Molecule (TCER®) in Recurrent and/or Refractory Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA402 in patients with recurrent and/or refractory solid tumors.

Primary objectives:

* To determine the maximum tolerated dose and/or recommended dose for extension for IMA402 (Phase I)
* To characterize the safety and tolerability of IMA402 (Phase I/II)
* To evaluate anti-tumor activity of IMA402 (Phase II)

Secondary objectives:

* To evaluate the initial anti-tumor activity of IMA402 (Phase I)
* To evaluate anti-tumor activity of IMA402 (Phase II)
* To describe the PK of IMA402 (Phase I/II)

The study will be conducted in two phases:

* Phase Ia: Dose escalation/de-escalation
* Phase Ib: Dose extension
* Phase II: Dose extension in selected Indication-specific extension cohort(s) (ISEC)

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients must have a specific pathologically confirmed and documented advanced and/or metastatic solid tumor indication
* Patients must have received or not be eligible for all available indicated standard-of-care treatments
* Measurable disease according to RECIST 1.1
* Confirmed HLA status
* ECOG Performance Status of 0 to 1
* Adequate baseline hematologic, hepatic and renal function, acceptable coagulation status

Exclusion Criteria:

* Other active malignancies that require treatment or that might interfere with the trial endpoints (ongoing adjuvant anti-hormonal treatment is allowed)
* The patient is pregnant or is breastfeeding
* History of hypersensitivity to components of IMA402 or rescue medications, if no alternative treatment option is available
* The patient has concurrent severe and/or uncontrolled medical disease. Any other health condition that would, in the investigator's judgement, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures
* Patients with active brain metastases
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.

No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer.

Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy treatment because of any malignancy, expected to last ≥1 months at time of recruitment for myelosuppressive therapy or at least one cycle of myeloablative therapy.
* Age 1 month to \<18 years at time of recruitment
* Written informed consent from patients and/or parents

Exclusion Criteria:

* Local skin diseases prohibiting wearing of the device.
* Denied written informed consent from patients and/or parent
Exercise in Dialysis

The purpose of the proposed clinical trial is to support intradialytic pedal cycling exercise as an intervention and show its effect on depression and how there is a need for more programs to support this. This is an exploratory single arm study. These patients will be cycling during dialysis treatment by using a graded duration model. Even though patients on hemodialysis (HD) have an increased life span due to renal replacement therapy, exercise can have a remarkable effect on their ability to perform daily activities. Dialysis has been shown to reduce self-confidence, increase social isolation, and cause feelings of disappointment in the future. This population faces mental and psychological stress due to the disease burden. Short-term supervised cycling programs while patients are receiving dialysis have been reported to induce systematic improvements for depression and anxiety. Exercise during hemodialysis is an effective way to reduce depressive symptoms without using pharmacologic measures.

Data for each patient will be collected at each dialysis treatment using a unique patient identifier. The data that will be collected include duration of exercise (intermittent or continuous), any complications during HD, vital signs while cycling every 30 minutes, and how they state they feel after cycling. The measurable outcome will be depression scores. The tool that will be used for this project is the Beck Depression Inventory (BDI). The patient will complete the BDI assessment on week 1 (pre intervention as baseline) and then on week 10 (post intervention).


Eligibility Criteria:
Inclusion Criteria:

1. greater than 18 years of age
2. male or female
3. ESKD on maintenance hemodialysis for 3 consecutive months
4. adequate dialysis clearances (Kt/V greater than 1.2),
5. able to participate in exercise program based on nephrologist evaluation
6. able to provide written informed consent for participation,
7. Compliance with dialysis treatment regimen (attended 75% of ordered dialysis treatments in the last 3 months.

Exclusion Criteria:

1. less than 18 years old
2. on hemodialysis for \< 3 consecutive months
3. acute Kidney Injury diagnosis
4. patients deemed clinically unstable by Nephrologist
5. active foot ulcer
6. unable to provide written consent
7. refusal of participation
8. lower limb amputations
9. patients with dementia or severe cognitive impairment
10. patients with Psychiatric disorders (who are not treated and unstable)
11. pregnancy
12. myocardial infarction in the last 6 months
13. uncontrolled diabetes
14. patients on chronic Midodrine therapy for intradialytic blood pressure support.
15. deep vein thrombosis
16. symptomatic peripheral vascular disease and/or recent lower extremities vascular intervention (i.e. bypass)
Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease

Stem cell transplantation has emerged as a relatively popular treatment that can help to regulate immunity, repair injury, and control inflammation. Several studies have used autologous stem cells or adipose-derived stem cells to treat Crohn's disease and its associated complications, and have achieved good efficacy. Thus far, the use of umbilical cord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. In this study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. We observed the disease control conditions, corticosteroid dosage changes, and treatment-related adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years of age
* moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220 and 450)
* had received hormone maintenance therapy for more than 6 months

Exclusion Criteria:

* active tuberculosis
* malignancy
* HIV
* syphilis
* hepatitis B
* hepatitis C
A Trial of SHR-1210 (an Anti-PD-1 Antibody) in Combination With Apatinib in Patients With Advanced TNBC

This is a Phase II, Open-labeled, Randomised, Parallel, Non-comparative, Two-arms, Investigator-initiated Clinical Trial of SHR-1210 (Anti-PD-1 Antibody) in Combination With Apatinib (VEGFR2 inhibitor) in Subjects with Advanced Triple Negative Breast Cancer. Subjects with advanced Triple Negative Breast Cancer will be recruited. Patients will be randomised to two treatment arms of this study. One arm is SHR-1210 combination with apatinib daily dosing, and the other arm is SHR-1210 combination with apatinib intermittent dosing; each arm will enrolle10-29 subjects (Simons two stage design).

This study aims to evaluate the efficacy and safety of SHR-1210 combination with apatinib in the treatment of advanced TNBC.


Eligibility Criteria:
Inclusion Criteria:

* The patients signed the written informed consent
* Women aged 18-70.
* The pathologic diagnosis of recurrent metastatic triple negative breast cancer ［ER-negative(IHC\<1%), PR-negative(IHC\<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］.
* At least one measuring lesion that conforms to RECIST v1.1 standard.
* The number of chemotherapy lines in the metastatic phase was \<3 line.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
* Have a life expectancy of at least 12 weeks.
* Female Subjects of childbearing potential must have a negative serum pregnancy test within 72 hours before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 3 months after the last dose of study treatment.
* The patients can swallow pills.
* The results of patients' blood tests are as follows: • Hb≥90g/L; • Plt≥90E+9/L; • Neutrophils≥1.5E+9/L; • ALT and AST ≤ triple of normal upper limit; • TBIL ≤ 1.5 times of normal upper limit; • Creatinine ≤ 1.5 times of normal upper limit.

Exclusion Criteria:

* The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
* Subjects with severe allergic reactions to other monoclonal antibodies.
* The subjects had a central nervous system metastases with clinical symptoms.
* History of hypertension and antihypertensive medications are not well controlled.
* A heart condition or disease that is not well controlled.
* Subjects had active infections or recent treatment with a systemic immunostimulatory agent (received within the previous 4 weeks).
* Other clinical trials of drugs were used in the first four weeks of the first medication.
* Subjects with treatment history of anti-angiogenesis drugs or check-point inhibitors.
Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD)

To study the potential therapeutic effects of topiramate (Topamax) in the treatment of PTSD.

This is a twelve-week randomized, double blind, placebo controlled trial of topiramate for 40 patients with PTSD. Diagnoses are made by Structured Clinical Interview for DSM-IV (SCID). Symptom severity is measured with the Clinician Administered PTSD Scale (CAPS), Davidson Trauma Scale (DTS), Treatment Outcome PTSD (TOP-8), Clinical Global Impressions (CGI), and the Hamilton Rating Scales for Depression and Anxiety (HAM-D and HAM-A). The Clinician Administered PTSD Scale (CAPS) is the primary outcome measure. Subjects will read and sign informed consent prior to beginning any study procedures. Subjects who meet inclusion/exclusion criteria will be randomized 1:1 (Topiramate : placebo) to study medication. Study medication is initiated at one tablet daily (25mg topiramate or placebo) and medication will be increased by 25-100mg (1 tablet) increments every 7 days, as tolerated, until a maximum benefit is achieved, not to exceed 400mg/day. Patients will be seen every week up until Visit 4, and then will be seen every two weeks for the remainder of the study for assessment of efficacy and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PTSD DSM-IV criteria
* No substance abuse/dependence for the previous 2 months (except for nicotine and caffeine)
* Free of psychotropic medication, for 2 weeks (except 6 weeks for fluoxetine)
* Normal physical and laboratory examination (lab profile listed below)
* Negative urine screen for drugs of abuse
* Women of childbearing potential must be using nonpharmacologic medically approved methods of birth control
* Signed informed consent
* Male or female, any race or ethic origin

Exclusion Criteria:

* Lifetime history of bipolar, psychotic, or cognitive disorders
* Suicidal, homicidal, or psychotic
* Diagnosis of bulimia or anorexia nervosa
* History of sensitivity to topiramate
* General medical conditions or ongoing treatment that contraindicate the use of topiramate, such as seizure disorder or use of MAO inhibitors.
* Women planning to become pregnant or breastfeed during the study
Neuronostatin - a Glucagonotropic Agent in Humans?

With the present study the investigators wish to delineate the effects of neuronostatin-13 (NST) on glucose-dependent glucagon secretion in humans. The main question it aims to answer is:

• What are the physiological effects of the naturally occuring hormone NST - especially with regards to glucagonotropic effects at different plasma glucose concentrations

In a randomized, double-blind crossover design, participants will undergo six experimental days with controlled plasma glucose levels, consisting of two euglycemic, two hyperglycemic (around 8mmol/l), and two hypoglycemic (around 2.5mmol/l) days, with each pair of similar days involving the administration of either saline (placebo) or NST.

With the present study the investigators wish to delineate the effects of neuronostatin on glucose-dependent glucagon secretion in humans. Thus, this study is designed to elucidate the physiological effects of the natural occurring hormone, neuronostatin, and not to examine a medical effect of a drug or treatment. However, if neuronostatin acts glucagonotropically during low plasma glucose concentrations it could potentially help to address the unmet medical need for a treatment that, ultimately, can counteract the high risk of hypoglycaemia in patients treated with insulin.

After being informed about the study and the potential risks, each participant giving written informed consent will participate in six double-blinded experimental days (Day A-F) in a randomized order. On each day, participants will receive an infusion of either saline (placebo)(day A, C and E) or NST (day B, D and F). On day A and B, blood glucose will be kept at fasting levels, on day C and D blood glucose will be increased to \~8mmol/l and on day E and F blood glucose will be lowered to \~2.5mmol/l.

Blood glucose will be adjusted with insulin and/or glucose to reach the desired levels on each day.

At the end of the study day, participants will receive an ad libitum meal.

The effects of each infusion will be evaluated with regards to glucagonotropic potency, as well as a series of exploratory outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Normal haemoglobin \>8.3 mmol/l
* Normal fasting plasma glucose below 7 mmol/l
* Normal HbA1C \<42 mmol/mol (6%)
* Body mass index (BMI) 18.5-27 kg/m2
* Oral and written informed consent

Exclusion Criteria:

* Diabetes
* Treatment with drugs that might interfere with glucose metabolism within a month prior to the research study
* Treatment with any medication that cannot be paused for 12 hours
* Known liver disease and/or alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>2 × normal values
* Nephropathy (eGFR \<60 ml/min and/or albuminuria)
* Any condition that the investigator feels would interfere with trial participation
Adalimumab Biosimilar in Clinical Practice

This is an observational, retrospective, multicenter, and descriptive study of patients treated with adalimumab biosimilar for psoriasis, according to clinical practice.

Existing data will be collected from the Dermatology Services database of the hospitals participating in the study, from the medical histories of all treated patients who meet the inclusion criteria and sign informed consent.

The aim of the study is to determine the effectiveness of the different adalimumab biosimilars in clinical practice.

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic treatment. There are currently several biosimilar drugs (Amgevita, Imraldi, Hyrimoz, Idacio, Hulio,...) in addition to the reference product (Humira).

The reduction in the cost of production of biosimilar drugs with respect to reference products has led to their replacement by biosimilar drugs in patients initiating biological therapy, but some centers are also switching to adalimumab biosimilar in patients who are controlled with original adalimumab (Humira).

There are no actual clinical efficacy / safety data in our setting on the use of adalimumab biosimilars.

There is also no evidence of maintenance response in patients who are switched from adalimumab (Humira) to biosimilar adalimumab in clinical practice.

This retrospective study will collect demographic and disease data of the psoriasis patient treated with the different biosimilars of adalimumab, as well as their comorbidities, response to treatment, and safety. In this way, data will be available in usual clinical practice to improve the management of the patient with psoriasis treated with biosimilar drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes who have received treatment with adalimumab and who have signed an informed consent.

Exclusion Criteria:

* Refusal to participate.
* Any other cause of exclusion based on clinical criteria and the technical data sheet of the drug.
Effects Dapagliflozin on Inflammatory Markers Erythropoiesis and Iron Metabolism in Patients with Type 2 Diabetes and CKD

the effect of Dapagliflozin on erythropoiesis, iron metabolism and inflammatory markers in CKD with Type 2 DM-Compare between effect of placebo and dapagliflozin on erythropoiesis, iron metabolism and inflammation markers in CKD with Type 2 DM.

Type 2 diabetes is considered an important cause of chronic kidney diseases (CKD) ,in those patients the inflammation is the most assumed cause of the decrease in erythropoietin synthesis and abnormal iron metabolism leading to anemia (1_3).

Sodium glucose cotransporter 2 (SGLT2) inhibitors like Dapagliflozin are oral medications approved for type 2 diabetes. interestingly, during recent years, they have been promisingly considered as anew medications for cardiovascular and kidney diseases (4). Researchers suggested that SGLT 2 inhibitors play an important role in reducing CKD progression and renal failure with patients with type 2 DM based on the clinical outcomes and laboratory findings rather than completely understood mechanism (5_8)

Investigators reported that reduced transferrin saturation (TSAT), ferritin and hepcidin and circulating and urinary inflammatory mediators, including monocyte chemoattractant protein-1 (MCP -1 ) and interleukin-6 (IL-6) transiently increased EPO suggesting SGLT 2 inhibition may help iron utilization and promote erythropoiesis decreasing anemia ( 9-14)

Here we are studying the effects of the SGLT 2 inhibitor Dapagliflozin regarding markers of erythropoiesis, iron metabolism and inflammation in patients with Type 2 DM and CKD.

Eligibility Criteria:
Inclusion Criteria:

Eligible participants were aged \>18 years and diagnosed with Type 2 diabetes participants we required to have urinary albumin-creatinine ratio (UACR ) of 30_3500 mg /g ,eGFR of 20_ 80 ml/min/ 1.73 m , and HbA1c of 7.0 _ 11.0 % at screening

Exclusion Criteria:

type 1 diabetes, non-diabetes kidney disease and patient with HB \< 9
Monitoring of Overdose Patients With and Without Supplemental Oxygen in the Emergency Department

This study will compare the data from pulse oximeters to capnographers as they are used to monitor patients who are being observed in the Emergency Department for a suspected overdose of alcohol or other drugs. The investigators will compare monitor data from patients who are and are not on supplemental oxygen, the ability of the monitors to predict the occurrence of airway interventions, and to detect ventilator changes noted on the opposing monitor. There will not be any interventions during this study other than the collection of data from the monitors and observation of the care of patients.


Eligibility Criteria:
Inclusion Criteria:

* Airway is being monitored as a result of overdose

Exclusion Criteria:

* Under 18 years old
* Unable to give informed consent at baseline
* Prisoners
A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty

This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.

Study objectives include: 1) testing the feasibility of a hybrid preoperative physical therapy intervention for physically deconditioned patients undergoing total hip and knee replacement, and 2) observing differences in post-surgical outcomes such as pain, pain interference, function and healthcare utilization, between patients who receive the intervention and those who do not.

Eligibility Criteria:
Inclusion Criteria:

* Patient is above 55 years old, indicated for primary total knee or hip replacement surgery and is deconditioned based on the surgeon's clinical judgement (i.e., Use of walker, limited or staggered gait, difficulty in sit to stand) as recorded in study log.
* Patient falls below the median score on the HOOS/KOOS JR/PROMIS physical function (\<47.4, \<49.8, ≤ 37 respectively and below the median score on the PROMIS Pain Interference score (≥63).
* Patient has access to technology to participate in telehealth.

Exclusion Criteria:

* Patient is not ambulatory
* Patient is scheduled for bilateral arthroplasty or revision arthroplasty.
* Patient is morbidly obese (BMI \>40).
* Patient has pre-existing medical condition that is contraindicated for exercise such as unstable cardiomyopathy