cyrilzakka/clinical-trials huggingface dataset:
A Study of CS23546 in Subjects With Advanced Tumors

The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.

This study is a single arm, open phase I trial, consisting of a dose escalation phase (single dose+multiple doses) and a dose expansion phase, accompanied by pharmacokinetic and pharmacokinetic studies. The first visit period (21 days) of single dose and multiple doses during the dose-increasing phase is the DLT observation period.

Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female and ≥18 years of age on day of signing informed consent.
2. Histologically or cytologically confirmed unresectable advanced recurrent/refractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available.
3. Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and/or Microsatellite instability (MSI) / the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
5. Adequate organ function.
6. Life expectancy ≥12 weeks.
7. Dose expansion phase: Cohort 1, Subjects with urothelial carcinoma. Cohort 2, Subjects with Extranodal NK/T-cell lymphoma (NKTCL). Cohort 3, Subjects with soft tissue sarcoma. Cohort 4, Subjects with PD-L1 expression positive and/or microsatellite-instability-high (MSI-H) / mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma

Key Exclusion Criteria:

1. Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days before the first medication.
2. History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) /PD-L1 antibody.
3. Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled.
4. Presence of central nervous system metastasis and/or meningeal metastasis.
5. Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.
Comparison Between Type A Botulinum Toxin Injection and Corticosteroid Injection in the Treatment of Tennis Elbow

Humeral lateral epicondylitis or tennis elbow is a common painful elbow disorder. The cause of tennis elbow is the chronic overload of bone-tendon junction. High prevalence of tennis elbow has a direct impact on the workplace productivity and quality of life. Steroid injection is the very few methods proved to have short-term efficacy in tennis elbow treatment, but it has potential adverse effects like tendon rupture. Temporary paralysis of muscle after botulinum toxin injection may reduce the physical demands and facilitate the normal repair mechanism during recovery. Preliminary studies suggested that botulinum toxin injection is effective in treating tennis elbow. The objective of this study is to compare the effects of botulinum toxin injection with corticosteroid injection in tennis elbow treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pain at the lateral epicondyle of the elbow
* Tenderness at the lateral epicondyle of the elbow
* Pain on resisted extension of the wrist

Exclusion Criteria:

* Local injection of steroid within 3 months
* Previous elbow trauma or operations
* Pregnancy
* Systemic neuromuscular disorders such as myasthenia gravis
Absorption, Stable Isotope Appearance and Non-transferrin-bound Iron (NTBI) Profile From NaFeEDTA and Ferrous Sulphate

Several iron compounds are used for fortification, including ferrous sulphate and NaFeEDTA. The absorption profile of these may differ because of differences in their dissolution in the gastrointestinal tract and in their interaction with dietary inhibitors of iron absorption. As these differences might lead result in varying reactions in the blood stream, the appearance rate of the stable iron isotope, hepcidin, non-transferrin-bound iron and total iron in the plasma will be monitored over six hours in adult women. This is relevant as a spike of absorbed iron may increase non-transferrin-bound iron and this could be pro-oxidative or increase growth of pathogens. Hepcidin is a key mediator of iron absorption and will help explain the potential differences in the plasma iron profile.

The use of stable iron isotope appearance curves to specifically detect the appearance of small amounts of absorbed iron in the blood and distinguish between circulating body iron and iron absorbed from the test meal was tested in a pilot study (EK 2008-23). This method is now used in a bigger sample to test the differences in absorption profile of ferrous sulphate, FePPi and NaFeEDTA given at fortification level with a meal.


Eligibility Criteria:
Inclusion Criteria:

* Serum ferritin \<60 ug/ l, haemoglobin \> 100 g/ l
* Women
* \< 65 kg body weight
* Healthy

Exclusion Criteria:

* Pregnant or lactating
* Taking iron supplements
Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1 and 2 hypertension without treatment for at least 2 weeks
* Women with no risk of becoming pregnant

Exclusion Criteria:

* Study participation could result in risk to health of subject
* Cardiovascular disease
* Secondary hypertension or stage 3 hypertension
* Myocardial infarction within the last 6 months
* Congestive heart failure
* Pulmonary edema
* Valvular alterations or rheumatic cardiopathy
* Clinically relevant conduction disorders significant arrhythmias
* Alcohol or illicit drug use
* Medication abuse
* Pregnant or nursing women
Intestinal Ischemia as a Stimulus for Systemic Inflammatory Response After Cardiac Arrest

Out-of-hospital cardiac arrest (CA) is a leading public health problem causing nearly one third of a million deaths annually in the US, accounting for half of all cardiovascular deaths and surpassing deaths from stroke, heart failure, and breast and lung cancer combined. Twenty to fifty percent of CA patients (pts) can be resuscitated initially but many die before hospital discharge or suffer permanent neurologic damage. Therapeutic hypothermia (TH) improves survival and neurological outcomes. Despite aggressive, targeted post arrest management, including TH, approximately 50% of pts die before leaving the hospital due to global ischemia-reperfusion injury (IRI) known as the "post arrest syndrome", 1 which is a sepsis-like state characterized by elevated markers of cellular inflammation and injury. It is believed that TH works by decreasing the body's basal metabolic rate (BMR) and attenuating the systemic inflammatory response (SIR). However, specific triggers of the intense pro-inflammatory response are unclear. This "gap" in knowledge must be closed to identify targeted therapy to decrease IRI and improve outcomes.

Blood flow to the gut is decreased markedly and intestinal tissue becomes ischemic during CA and CPR, particularly when vasoconstrictor drugs such as epinephrine, are given. IRI of the intestine increases intestinal permeability leading to intestinal microbial translocation and endotoxin release that can stimulate and perpetuate systemic inflammation and cause subsequent multi-organ dysfunction. Endotoxin also increases body temperature and energy expenditure and may attenuate TH induced reductions in BMR and hence, decrease efficacy. The purpose of this novel pilot study is to detect systemic endotoxin release following CA in humans and determine association with cytokine activation, and BMR alterations during TH.

Hypothesis 1 Intestinal ischemia during and following Caridac Arrest leads to increased gut permeability and endotoxin release that stimulates the Systemic Inflammatory Response that is responsible for subsequent death and disability after resuscitation.

Hypothesis 2: Different degrees of systemic endotoxin activity variably affect Basic Metabolic Rate during Therapeutic Hypothermia

Serial samples of blood, stool and expired gas will be measured at predetermined timepoints after ROSC from cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

Adult, Cardiac Arrest with ROSC receiving Therapeutic Hypothermia-

Exclusion Criteria:

* Age \< 18
* Cardiac Arrest of traumatic etiology
* Known to be pregnant
* Prisoner
Chordate System S020 Acute Migraine Clinical Investigation

The main purpose of the study is to evaluate the impact of treatment with the Chordate System S020 (medical device) on acute migraine headache pain.

One single migraine attack will be treated either with the Chordate System S020 or with Chordate System in placebo mode.

After a screening visit, up to 3 months before treatment, eligible subjects will be asked to return to the center at the onset of their next moderate to severe migraine attack. Subjects will be re-checked for eligibility, randomized and treated at the center (treatment visit). The subjects will record their response over the next 48 hours using a diary card. A follow-up visit will be scheduled 3 to 7 days after the treatment. In addition the subjects will be contacted within 24 to 48 hours after treatment initiation via a telephone contact to discuss their health including new or ongoing AEs.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with migraine, with or without aura according to International Headache Society (IHS) classification (International Classification of Headache Disorders \[ICHD\]-III beta).
* History of 1 to 6 migraine attacks per month for at least 12 previous months.
* At least 50% of previous migraine attacks had moderate or severe pain intensity.
* History of at least 48 hours of freedom from headache between migraine attacks.
* The majority of the previous untreated migraine attacks lasted at least 8 hours.
* Migraine onset before the age of 50 years.

Exclusion Criteria:

* History (within one year prior to inclusion into this clinical investigation) of 15 or more headache days per month (i.e. headaches of any kind).
* More than 6 days per month with non-migraine headaches (within one year prior to inclusion into this clinical investigation).
* Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack.
* Treatment with Botox in the head/neck area within 6 months of the screening visit, or between the screening and treatment visit.
* Previously treated with an implantable stimulator or any implantable devices in the head and/or neck.
* Pronounced anterior septal nasal deviation.
Can a Nasal Decongestant Test Predict Treatment Outcomes in Seasonal Allergic Rhinitis?

We hypothesize that those patients with purely seasonal allergic rhinitis will decongest better than those subjects with another cause contributing to their symptoms. These latter patients will not improve as well on an intranasal steroid as those who decongest well, potentially explaining the 60% response rate in prior studies.


Eligibility Criteria:
Inclusion Criteria

1. Males and females between 18 and 60 years of age.
2. History of grass and/or ragweed allergic rhinitis.
3. Positive skin or RAST test to grass, trees and/or ragweed antigen.
4. Symptomatic at time of entry into study.

Exclusion Criteria

1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are pregnant or breastfeeding.
2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
3. Use of any other investigational agent in the last 30 days.
4. Absence of nasal symptoms.
5. Smoking.
6. URI at the time of screening.
a Multicenter Clinical Trial for the Treatment of Children and Adolescents With Soft Tissue Sarcoma Stage 4

Phase II Study to evaluate the response on two blocks of topotecan and carboplatin

Phase II study for patients with chemosensible soft tissue sarcoma stage IV in children and adolescents ; response according to RECIST criteria following two blocks of combination therapy consisting of Topotecan and carboplatin

Eligibility Criteria:
Inclusion Criteria:

* Soft tissue sarcoma chemosensible, stage IV
* age \< 21
* measurable tumor lesions

Exclusion Criteria:

* Lack of cooperation by the patient
* no willingness of follow-up examinations
* participation on another clinical trial at the same time
* death due to the sickness within four weeks
Nocturnal Leg Cramps in Geneva : an Observational Study

Background :

Nocturnal leg cramps (NLC) are defined as painful involuntary contractions of the lower limbs occurring during prolonged periods of rest, typically during the night. They may cause severe pain and sleep disturbance, and are particularly common among older adults, though they can occur in all decades of life. They are frequently unreported to physicians. To the investigators' knowledge, no epidemiological studies have been conducted in Switzerland, but in a general population survey carried out in the UK (n=233), the overall prevalence of NLC was 37% and the disorder was more prevalent in older subjects (\>80 years old: 54%). Of those who experienced NLC, 40% had cramps three or more times per week and 6% nightly. Another study performed in older US veterans (n=515) showed that 56% suffered from NLC.

The precise cause of these cramps is unclear. Most NLC occurring in adults appear to be idiopathic, but potential contributing factors include low levels of certain minerals, extracellular fluid volume depletion and prolonged sitting or inappropriate leg position during sedentary activity.

Research question :

What are the prevalence and the main features of NLC in patients consulting primary care physicians (PCPs) in Geneva, and how do PCPs treat this affection?

Primary objective :

To compute the prevalence of NLC in patients consulting PCPs in Geneva, explore its main features (number, duration, severity and sleep disturbance) and assess how PCPs treat this affection.

Study design :

Prospective observational study using questionnaire and daily log completed by patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients of 50 years old or more,
* currently presenting NLC (The definition of NLC used for the purpose of the study is any cramp in the legs or feet, occurring during the sleep (eg long rest) period).
* coming to the practice for a planned consultation.

Exclusion Criteria:

* Patients suffering from a terminal illness
* from disorders affecting their ability to consent,
* not speaking French
* or not having a telephone.
A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had an ileostomy for more than one year
4. Have intact skin on the area used in the evaluation
5. Has an ileostomy with a diameter up to (≤) 35 mm
6. Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
3. Are pregnant or breastfeeding
4. Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist)
5. Participating in other interventional clinical investigations or have previously participated in this evaluation
Novel Applications for Sarcoma Assessment

This research aims to improve the way of deciding whether a lump in soft tissue such as fat or muscle is a type of cancer called a soft tissue sarcoma, or if it is benign (non-cancerous). To do this the investigators will use routine clinical MRI scans, additional quantitative MRI scans and artificial intelligence.

The aims of this research are:

To develop AI algorithms that can accurately classify soft tissue masses as benign or malignant using routine and quantitative MR images.

To classify malignant soft tissue masses into their pathological grade. Compare different AI models on external, unseen testing sets to determine which offers the best performance.

Participants will be asked if they can spend up to a maximum of 10 extra minutes in an MRI scanner so that the extra images can be acquired. A small subset of participants will be invited back so the investigators can check the reproducibility of the images and the AI software.

This research's aim is to improve the way of deciding whether a lump in soft tissue such as fat or muscle is a type of cancer called a soft tissue sarcoma, or if it is benign using artificial intelligence (AI).

Soft tissue sarcomas are a type of cancer that can appear anywhere in the body where there is soft tissue such as muscle or fat. While sarcomas are rare, benign lumps in soft tissue are common and it is currently very difficult to tell the difference between the two using imaging. This means many patients with benign masses are referred for painful biopsies and waiting lists for biopsies are long due to the large diagnostic workload.

This research aims to develop an AI algorithm that can differentiate between benign and malignant soft tissue masses. While an algorithm can be developed using existing routine data the researchers would like to investigate if adding quantitative MR images could make it more accurate.

Patients who are already having a scan for sarcoma will be asked if they consent to extra MR images being acquired. These images will be used to provide extra information to the AI. The extra images will add a maximum of 10 minutes to the patients' standard MRI scan, meaning patients will not need to make an extra trip or undergo any extra procedures. Study participants will not need to receive MR contrast as part of this research. The extra images will not be used to make a diagnosis during this research. A small subset of patients will be asked if they would be willing to come for a second scan so that the researchers can see how reliable the measurements are, but this will be entirely optional.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a soft tissue mass that are discussed at the sarcoma multi-disciplinary meeting
2. Undergoing MRI as part of their standard of care
3. Participant is willing and able to give informed consent for participation in the trial.

Exclusion Criteria:

1. Patient has already had the mass, or part of the mass, surgically removed prior to their MRI scan
2. Contraindication to MRI (e.g. presence of contraindicated implants e.g. cardiac pacemakers, claustrophobia).
Ultrasound-guided Versus Direct Palpation Radial Artery Catheter Insertion Among Cardiac Anesthesiologists

When a patient undergoes heart surgery, their Anesthesiologist will insert a tiny plastic tube, called a catheter, in the artery of the patient's wrist. This is called a radial artery catheter. A radial artery catheter allows accurate measurement of the patient's blood pressure during surgery. There are two common techniques for placing the radial artery catheter. The first is a "blind" technique whereby the Anesthesiologist feels for the pulse in the patient's wrist and places the catheter using the location of the pulse as a guide. The second technique, less commonly used, is one whereby the Anesthesiologist uses an ultrasound machine (painless to the patient) to "see" the artery, and thereby uses the ultrasound to guide the catheter placement. Our study will test the hypothesis that ultrasound-guided radial artery catheterization will have faster insertion times, with fewer complications compared with palpation-guided insertion.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery
* Age 19 or older
* Provided written informed consent

Exclusion Criteria:

* Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease, as judged by the investigator
* Previous surgery at the site of proposed radial artery catheterization
* Any vascular condition that may preclude eligibility for radial artery line insertion as judged by the investigator
* Patients with ventricular assist devices
* Previous inclusion in this study
Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).


Eligibility Criteria:
Inclusion Criteria:

* New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
* Have signed informed consent

Exclusion Criteria:

* Participating in other research protocol
* Inability to follow a monitoring
Identification of Stroke Patients ≤ 3 and ≤ 4.5 Hours of Symptom Onset by Fluid Attenuated Inversion Recovery (FLAIR) Imaging and Diffusion Weighted Imaging (DWI)

The aim of the study is to evaluate the use of combined fluid attenuated inversion recovery (FLAIR) imaging and diffusion weighted imaging (DWI) as surrogate marker of lesion age within the first 6 hours of ischemic stroke in order to identify patients ≤ 3 or ≤ 4.5 hours of symptom onset in a large multicenter study hours of ischemic stroke. The investigators hypothesize that the pattern of a visible lesion on DWI together with a negative FLAIR ("DWI-FLAIR mismatch") will identify patients ≤ 3 hours of symptom onset with \>80% specificity and positive predictive value.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke (proven by initial or follow-up MRI)
* Well defined and known symptom onset
* Stroke MRI including diffusion weighted imaging (DWI) and fluid attenuated inversion recovery (FLAIR) sequences performed within 12 hours of symptom onset
* Informed consent

Exclusion Criteria:

* Contraindications against MRI