cyrilzakka/clinical-trials huggingface dataset:
Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma

To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder cancer.


Eligibility Criteria:
Inclusion Criteria:

1. 18-75 years old, male or female;
2. Heart function is normal;
3. Normal heart function;
4. Estimated survival ≥12 weeks;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.
Effects of Oral Sodium Bicarbonate Supplementation in Haemodialysis Patients (BicHD)

The purpose of the study is to investigate whether oral sodium bicarbonate supplementation to ensure a constant bicarbonate profile in haemodialysis patients will primarily lower predialysis potassium levels and secondary lead to improvements in cardiac function, muscle mass and dialysis related symptoms.

Background:

One of the functions of dialysis is to correct electrolyte abnormalities which occur with renal failure, such as variations in potassium and bicarbonate levels, which are linked to important clinical outcomes for patients. Metabolic acidosis, reflected by falling bicarbonate levels, is a frequent event in haemodialysis patients and its correction is one of the goals of effective dialysis. Bicarbonate replacement is routinely delivered during each dialysis session thrice weekly with the use of high dialysate bicarbonate. However, local and national data show that over 50% of patients fail to meet a bicarbonate level within the normal range before each dialysis session. Low predialysis bicarbonate levels of less than 22mmols/L have been linked with increased all-cause mortality in haemodialysis patients.

Evidence from previous studies suggests that a continuous replacement (i.e. daily) with oral sodium bicarbonate capsules may be a superior correction of acidosis to the current treatment of intermittent replacement during dialysis.

Aims and objectives:

This randomised controlled study aims to investigate the effects of oral sodium bicarbonate supplementation on:

Primary objective: Pre and post dialysis potassium without increasing intradialytic potassium gradient.

Secondary objectives:

1. Risk of arrhythmia as measured by ECG analysis
2. Muscle mass as measured by body composition monitoring
3. Muscle function as measured by handgrip strength
4. Haemodialysis related cramps as measured by a symptom scale-renal questionnaire

Patients will be recruited from Imperial College Healthcare NHS (National Heath Service) Trust haemodialysis units and randomised to two equally numbered groups. One group will receive the standard dialysis treatment (control) and the other one will receive the standard dialysis with the addition of capsules of sodium bicarbonate (intervention). The dose of sodium bicarbonate will be adjusted according to individual levels. The study duration is 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

Patients on haemodialysis for at least 3 months, Patients who primarily have predialysis bicarbonate levels of less than 22mmols/L over the last 6 months, Patients who are not already taking oral sodium bicarbonate, Able and willing to provide written informed consent

Exclusion Criteria:

Patients who primarily have predialysis potassium levels of less than 4mmols/L over the last 6 months, Patients who are already taking oral sodium bicarbonate, Patients on lithium, Bedbound patients, Pregnant patients, Dementia, Recurrent hospital admissions, Non-English speaking and unable to provide written informed consent
Olanzapine Versus Aripiprazole in the Treatment of Acutely Ill Patients With Schizophrenia

The purposes of this study are to assess similarities and differences in the efficacy (how well the drug works), safety, and side effects of olanzapine and aripiprazole in patients with schizophrenia, schizoaffective disorder, or schizophreniform disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Patients must be agitated
* Patients must display psychotic symptoms
* Patients must be inpatients who are expected to stay in the hospital for at least 5 days
* Patients must be 18 to 55 years of age

Exclusion Criteria:

* Patients may not be hospitalized for greater than 72 hours prior to study start
* Patients may not have received more than one dose of olanzapine or aripiprazole within 72 hours prior to study start
* Patients may not be actively suicidal
* Patients may not be diagnosed with substance-induced psychosis or substance dependence
* Patients may not have acute, serious, or unstable medical conditions
Tolerability of Asasantin in Healthy Female and Male Subjects

To investigate the occurrence of dipyridamole associated headaches in healthy subjects using a titration scheme or not


Eligibility Criteria:
Inclusion Criteria:

* All participants in the study should be healthy females/males, range from 18 to 55 years of age and be within a Broca Index of ≥ - 20 % and ≤ + 20 %
* Prior to admission to the study all subjects will have given, in accordance with good clinical practice (GCP) and the local legislation, their written informed consent.

Exclusion Criteria:

* Subjects will be excluded from the study if the results of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and are of clinical relevance
* Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders or neurological disorders
* Subjects with known history of orthostatic hypotension, fainting spells or blackouts
* Subjects with chronic or relevant acute infections
* Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Subjects who have taken a drug with a long half-life (\> 24 hours) (≤ 1 month prior to administration or during the trial)
* Subjects who received any other drugs which might influence the results of the trial (≤ 10 days prior to administration or during the trial)
* Subjects who have participated in another study with an investigational drug (≤ 1 month prior to administration or during the trial)
* Subjects who smoke more than 15 cigarettes or 4 cigars or 4 pipes/day
* Subjects who are not able to refrain from excessive consumption of methylxanthine containing drinks or food
* Subjects who drink more than 60 g of alcohol per day
* Subjects who are dependent on drugs
* Subjects who have donated blood (\> 400 ml) (≤ 4 weeks prior to administration or during the trial)
* Subjects who have participated in excessive physical activities (≤ 5 days prior to administration or during the trial)

For female subjects:

* Pregnancy
* Positive pregnancy test
* No adequate contraception (acceptable: e.g. sterilisation, intrauterine devices (IUD), oral contraceptives, condoms)
* Inability to maintain this adequate contraception during the whole study period
* Lactation period
Sexual Function in Patients Suspected of Non-muscle Invasive Bladder Cancer

The purpose of the study is to investigate sexual function in patients suspected of non muscle invasive bladder cancer (NMIBC). The investigators hypothesis is that reduced sexual function is underdiagnosed in patients with non-muscle invasive bladder cancer and that active examination and treatment may worsen the sexual function.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary hematuria, both gross and microscopic
* Men and women older or equal to 40 years of age
* Signed informed consent statement

Exclusion Criteria:

* Men and women younger than 40 years of age
* Patients with recurrent hematuria and known causative disease
* Already known urogenital cancer
* Previous massive pelvic surgery or pelvic radiotherapy
* TUR-P within the last 2 months
* Participants diagnosed with tumors originating from the ureters, renal pelvis and kidney, and bladder tumors at T stage more than or equal to T1b.
Home-based Heat Therapy for Type 2 Diabetes

Insulin resistance and hyperglycemia predispose individuals with type 2 diabetes mellitus (T2DM) to endothelial dysfunction and a greater risk of cardiovascular diseases (CVD). Increased CVD risk in individuals with T2DM persists despite optimal pharmacological therapy, highlighting the need to identify complementary lifestyle interventions that improve cardiometabolic functions in this population. Evidence from animal models suggests that heat exposure improves metabolic functions. Notably, weekly heat exposure for 16 weeks blunts hyperinsulinemia and hyperglycemia induced by a high fat diet in mice. In parallel, studies in humans have shown that heat exposure improves vascular endothelial function. Based on such findings, it has been suggested that heat therapy may represent an effective lifestyle intervention to improve cardiometabolic functions. However, only 1 study has examined the impact of a heat therapy intervention on individuals with T2DM, demonstrating that 6 weeks of heat exposure reduces fasting plasma glucose and hemoglobin A1C. No study has considered potential vascular benefits of heat therapy in individuals with T2DM.

This project will investigate cardiometabolic responses to repeated heat exposure in men and women with T2DM. We will test the hypothesis that 12 weeks of heat therapy improves postprandial fatty acid handling, insulin sensitivity and endothelial function in individuals with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Age 45-75 years
* Diagnosis of type 2 diabetes mellitus ≥1 year
* Stable medication ≥12 weeks

Exclusion Criteria:

* Class 3 obesity
* Hypertension not controled by medication
* Diagnosis of cardiac, renal and/or pulmonary disease
* Diagnosis of severe neuropathy and/or retinopathy
* Insulin therapy
* Fasting plasma triglycerides \>5.0 mmol/L
* Fasting total cholesterol \>7 mmol/l
The Use of the Master Caution System (MCS) for Continuous Monitoring and Detection of Dysrhythmias and Ischemic Events

The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.

The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.

The purpose of the study is to reassess the adequate size of the Master Caution Garment.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years.
* Diagnosed or have evidence of ACS, or referred for stress imaging due to suspected ischemia with STT changes.
* Needs continuous/routine ECG monitoring.
* Ability to give informed consent.
* Cooperative person

Exclusion Criteria:

* Patients with known allergy to silver.
* Patients with dermal disease or recent trauma to the chest wall.
* Pregnant or lactating woman.
* Patients with chest deformity precluding placement of the garment.
* Patients suffering from tremor.
* Patients participating in another ongoing trial.
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Zampilimab in Adult Kidney Transplant Recipients With Chronic Allograft Injury

The main purpose of the study is to investigate the safety and tolerability of repeat dosing with zampilimab in kidney transplant recipients with deteriorating kidney function associated with chronic allograft injury (CAI).


Eligibility Criteria:
Inclusion Criteria:

* Functioning living or deceased donor allograft \>=1 year post-transplantation
* Baseline (screening) biopsy showing Grade II or III interstitial fibrosis/tubular atrophy (IF/TA) (\>=25% IF/TA)
* Progressive loss in kidney function observed after the first year post-transplant, defined as an estimated glomerular filtration rate (eGFR) decline of ≥3 mL/min/year for at least 24 months prior to screening, with a minimum of 2 documented measurements per year (minimum of 4 documented measurements in the 24-month period, performed at least 1 month apart)
* An eGFR \>=30 mL/min/1.73 m\^2 for a period of 6 months up to screening
* Stable standard of care concomitant medication for 3 months prior to screening
* Participant is male or female, \>=18 years of age

Exclusion Criteria:

* Recipient of multi-organ transplant (with the exception of repeated kidney transplant recipients, and/or corneal transplant recipients)
* Screening biopsy shows evidence of significant active antibody-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the Principal Investigator (PI)
* Screening biopsy shows evidence of T cell-mediated rejection that may affect the conduct of the study (eg, require change in treatment) according to the PI
* Screening biopsy shows evidence of de novo or recurrent glomerular disease that may affect the conduct of the study (eg, require change in treatment) according to the PI
* Proteinuria ≥1500 mg/g at screening
* Participant who has a history of biopsy-proven acute rejection or treatment for suspected acute rejection within 3 months prior to screening
* Participant has had major surgery (including joint surgery) within 6 months prior to screening, or has planned surgery within 6 months after the last dose of investigational medicinal product (IMP)
* Participant has a current diagnosis of foot ulcer or diagnosis of chronic diabetic ulcer or history of delayed wound healing
* Participant has taken concomitant medication of sirolimus or everolimus within 3 months of screening
Synovial Proliferation on Routine Ultrasound: Active or Inactive?

There is cumulating evidence for the presence of non-observed or subclinical joint bleeding in patients with haemophilia. Early detection of active subclinical synovial proliferation would allow early intervention in order to prevent deterioration of joint health. Patients with subclinical (=non-observed) signs of synovial proliferation in knee(s), ankle(s) and/or elbow(s) will be invited to participate in this study to further characterize the synovial proliferation status (active or inactive) by means of physical examination, MRI, ultrasound and elastography. Synovial proliferation status will be monitored for a maximum period of 12 weeks, during which participants will also receive standard-of-care treatment, i.e. administration of optimized coagulation factor replacement therapy and prescription of the NSAID celecoxib (optional).

To be completed

Eligibility Criteria:
Inclusion Criteria:

* Gender: male
* Patients with severe haemophilia A or B
* Treated with registered prophylaxis medication including coagulation factors and by- passing agents.
* Age ≥ 12 years
* Subclinical synovial proliferation in ≥1 joint (ankle, knee and/or elbow), defined as the presence of hypertrophic synovium, score \>0 according to the HEAD-US protocol, as confirmed during routine ultrasound screening.
* Able to give written informed consent.

Exclusion Criteria:

* A major bleed ≤ 3 months or a minor bleed ≤ 1 month prior to inclusion in the joint of interest.
* On demand therapy.
* Currently treated with any type of haemophilia prophylaxis medication.
* Joints with prosthesis or treated with arthrodesis will not be included for physical examination and ultrasound analysis. However, participants may still be included in the study with their other joints.
* Confirmed inflammatory joint diseases such as rheumatoid arthritis or psoriatic arthritis.
* History of inhibitor development (≥ 5 Bethesda Units\* (BU) at any time or 1-5 BU for

  * 1 year prior to inclusion.
* Contra-indication for treatment with NSAIDs, (allergy, severe liver failure, renal failure (GFR \<30ml/min), congestive heart failure (NYHA II-IV), peripheral arterial disease and/or cerebrovascular disease.
Effects of Manual Therapy Combined With Therapeutic Exercise on Brain Biomarkers in Neck Pain

Structural brain alterations in pain-related areas have been demonstrated in patients with nonspecific neck pain. While manual therapy combined with therapeutic exercise is an effective management for neck pain, its underlying mechanisms are poorly understood. The primary objective of this trial is to investigate the effects of manual therapy combined with therapeutic exercise on brain imaging biomarkers in patients with chronic nonspecific neck pain. The secondary objectives are to assess neurochemical biomarkers, clinical features of neck pain, cervical range of motion and cervical muscle strength.

This study is a single-blinded, randomized controlled trial. Forty-eight participants with chronic nonspecific neck pain will be recruited into the study. Participants will be randomly allocated to either an intervention or control group (1:1 ratio). Participants in the intervention group will receive manual therapy combined with therapeutic exercise for 10 weeks (2 visits per week). The control group will receive routine physical therapy. Primary outcomes are brain imaging biomarkers (cortical gray matter: volume, thickness and area, and white matter: fractional anisotropy and mean diffusivity) in pain-related areas. Secondary outcomes are neurochemical biomarkers (N-acetylaspartate, NAA; creatine, Cr; glutamic acid/glutamine, Glu/Gln; myoinositol, mI; and choline, cho), clinical features (neck pain intensity, duration, neck disability and psychological symptoms), cervical range of motion and cervical muscle strength.

Eligibility Criteria:
Inclusion Criteria:

* a history of nonspecific neck pain for ≥ 3 months
* an average pain intensity over the past week ≥ 35 mm. on a visual analogue scale (VAS)

Exclusion Criteria:

* a history of head and neck injury or surgery
* known or suspected vestibular pathology or dizziness caused by underlying pathology in the ear, brain and sensory nerve pathways (e.g. benign paroxysmal positional vertigo) and/or vascular disorders
* any neurological or musculoskeletal condition that could affect the outcomes (e.g., scoliosis, torticollis, myofascial pain syndrome, fibromyalgia and rheumatoid arthritis)
* metabolic conditions (e.g., diabetes, obesity (BMI \> 30 kg/m2) and hypertension)
* psychological symptoms (e.g., anxiety, depression and schizophrenia)
* contraindications to MRI (e.g., pregnancy/breastfeeding, claustrophobia and ferromagnetic implants)
* receiving physiotherapy treatment for their neck conditions in the past 12 months.
A Trial Investigating the Efficacy and Safety of Flexible vs. Fixed Dosing and Simple vs. Stepwise Titration With Once Daily (OD) Insulin Degludec in Inadequately Treated Subjects With Type 2 Diabetes

This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Current treatment with IGlar (insulin glargine) with or without OADs (oral antidiabetic drug). All antidiabetic treatments should have been on-going for at least 12 weeks prior to randomisation, and doses of OADs should have been stable in this period of time. - Please note that a maximum of 3 OADs are allowed during this trial: metformin, sulphonylurea (SU)/glinides, dipeptidyl peptidase 4 (DPP-IV) inhibitors, alfa-glucosidaseinhibitors or pioglitazone.
* Diagnosis of T2DM (type 2 diabetes mellitus) at the discretion of the investigator for at least 26 weeks prior to visit 1 (Screening visit)
* HbA1c 7.0-9.5% (both inclusive) by central laboratory analysis
* Body mass index (BMI) equal to or below 35 kg/m\^2

Exclusion Criteria:

* Any chronic disorder or severe disease which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
* Stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty; all within the last 26 weeks prior to Visit 1 (Screening visit)
* Impaired renal function, defined as serum-creatinine higher than or equal to 1.4 mg/dL for males and higher than or equal to 1.3 mg/dL for females
* Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
* Treatment with glucose-lowering agent(s) other than stated in the inclusion criteria in a period of 12 weeks prior to randomisation
Long-term Stability and Survival Rates of a Novel Oticon Medical Bone Conduction Device Implant

The overall aim of the study is to investigate the Ponto wide implant considering; initial implant stability, stability over time, skin reaction and long term success when loaded at 3 weeks post surgery. Patients' quality of life improvements following implantation will also be surveyed.

More specifically the primary objective of this clinical study is to test the hypothesis

* The new Ponto wide diameter implant offers increased implant stability measured as ISQ (implant stability quotient) compared to the previous generation Ponto implant.

And the secondary objective is to

* Investigate when in time implant stability is the lowest as the initial mechanical stability is gradually replaced by biological stability


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patient indicated for an ear level bone anchored sound processor
* Bone thickness at the implant site of at least 4 mm

Exclusion Criteria:

* Longer abutment (\>6mm) required
* Inability to participate in follow-up
* Psychiatric disease in the medical history
* Mental disability
* Presumed doubt, for any reason, that the patient will be able to show up on all follow ups
* Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.