cyrilzakka/clinical-trials huggingface dataset:
Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2

The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.

In this Phase II, open label study, patients will receive daily low-dose subcutaneous rIL-2 (1.2 x 10\^6 IU/m\^2/day) continuously beginning on day 1. Patients will receive 3 weeks of IL-2, and on day 22 will receive the monoclonal antibody huJ591 via I.V. (25mg/m\^2) for 3 consecutive weeks. Il-2 will be continued for 2 additional weeks for a total of 8 weeks. The 8 week regimen will constitute 1 cycle of therapy. Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.

Eligibility Criteria:
Eligibility Criteria:

* Histologic diagnosis (recent or remote) of prostate adenocarcinoma
* Metastatic or recurrent carcinoma of the prostate defined by abnormal CT or MRI and/or abnormal bone scan and/or rising PSA.
* Rising PSA on 3 serial determinations over a period of \> or equal to 2 weeks.
* PSA \> or equal to 1.0 at the time of entry.
* If patient is being treated with an LHRH analog the drug: a. must be maintained for the duration of the study or b. must be terminated \> or equal to 10 weeks prior to entry (for 28 day depot preparations) or 24 weeks (for 3 month depot preparations).

Exclusion Criteria:

* Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry.
* History of CNS metastasis, and/or history of seizure and/or stroke.
* Lab values: ANC\<1500/mm3; platelet count\<100,000/mm3; serum creatinine\>2.0; SGOT\>2 x normal; bilirubin (total)\>1.5; serum calcium\> or equal to 11.5.
* Active serious infection not controlled by antibiotics.
* Active angina pectoris or NYHA Class III-IV.
* Karnofsky Performance Status \<60.
* Life Expectancy \< 3 months.
* Age\< 21y.
* Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
* Untreated thyroid disease, with the exception of treated and stable hyperthyroidism or hypothyroidism for at least 4 weeks prior to entry.
Chronic Pain After Inguinal Hernia Repair

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.

A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.

Two techniques of inguinal hernia repair will be evaluated:

1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* primary unilateral inguinal hernia
* 18 years and older

Exclusion Criteria:

* bilateral hernia
* recurrent hernia
* incarcerated hernia
* malignant disease within the last 5 years
* not able to understand the questionaire
Effect of Exercise on Risk-factors of Elderly Women

The purpose of this study is to determine whether exercise training may impact relevant risk factors and health costs of community living women older 65 years.

The human aging process is associated with a significant increase of risk factors (i.e. osteoporosis, coronary heard disease, diabetes) and a decline in neuromuscular function impacting independence of the subject. Osteoporosis, diabetes type II and arteriosclerosis are diseases known to correlate with age. Participating in regular sport activities elicits numerous favorable effects that contribute to "healthy aging". Unfortunately all existing studies which focus on specific diseases or conditions favour dedicated exercise regimes. However, the complex risk factor scenario of older adults requires multi-purpose exercise programs with impact on all relevant risks. Furthermore so far no exercise study longitudinally determines the effect of an ambulatory exercise program on health cost considering the specific health policy framework of Germany. We hypothesize that regular exercise

1. significantly impact relevant osteoporosis, cardiovascular diseases and diabetes risk factors in elderly subjects
2. significantly reduces health costs in elderly community living women

Eligibility Criteria:
Inclusion Criteria:

* Community living Caucasian woman ≥ 65 years; live expectation \> 2 years

Exclusion Criteria:

* secondary osteoporosis
* CVD-events including stroke
* Participation in other studies
* Medication with impact on bone during the last 2 years:

  * bisphosphonates
  * parathormone
  * strontium
  * HRT, anabolic steroids
  * calcitonin
  * natriumflourides
  * active Vit-D-metabolites
  * cortisone \> 5 mg/d
* medication with impact on falls
* low physical performance (\<50 Watt during ergometry)
* excessive alcohol-intake
Channel Interaction in Cochlear Implant and Speech Understanding in Noise

The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients' specificities in order to maximize speech understanding in every day conditions especially in noise.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in French
* Able to understand written instructions
* Under French public medical insurance

  * Normal-hearing subjects only:

    * Adult between 18 and 50 years old
    * Without a remarkable otological medical history, for example: chronic otitis, trans-tympanic tubes and / or all ear surgeries;
    * Clear auditory canal and normal eardrum;
    * Average audiometric loss under 20 decibels Hearing Level (dB HL)
  * Cochlear implant users only:

    * Adult between 18 and 60 yo
    * Normal middle ear
    * Used the cochlear implant for more than a year
    * Wearing a device from the company Neurelec/Oticon Medical

Exclusion Criteria:

* Behavioral and/or neurological disorders
* Proven psychological disorder
* Use of psychotropic medication
* People who experience migraine attacks on a regular basis
* Use of ototoxic medication
* Exposed to loud noises within the last 72 hours
* Included in another clinical trial that uses medication
Reference Value of Figure of 8 Walk Test

The aim of the study is to determine the reference values of the Figure 8 Walking Test in healthy adults.

The Figure 8 Walk Test is a standard clinical measurement used to evaluate advanced walking performance required in daily life. Beyond walking straight, the ability to turn is required in many situations in daily life, such as getting around a table, avoiding obstacles, and navigating the street. The validity and reliability of the figure of 8 walk test have been stated for different pathological conditions, but the normative values of the test in healthy individuals are unknown.

Eligibility Criteria:
Inclusion Criteria:

* -Above 18 years old
* No known musculoskeletal and neurological disorders
* healthy adults who are not elite or professional athletes

Exclusion Criteria:

* People with physical or cognitive impairments
Use of Incretins in Diabetic Patients

Observational, retrospective study, conducted in diabetic patients aimed to evaluate the effects on the glyco-metabolic control and on cardiovascular events of different DPP-4 inhibitors. Patients will be stratified in patients taking different DPP-4 in addition to sulfonylureas, biguanides, thiazolidinediones, insulin, compared to those in therapy with other hypoglycemic classes, such as sulphonylureas, biguanides, thiazolidinediones, insulin, alone or in combination, in primary and secondary prevention.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients
* On oral hypoglycemic agents ± basal insulin
* In primary and secondary prevention

Exclusion Criteria:

- Patients with a follow-up of less than 8 years
Incremental Vestibulo-ocular Reflex Adaptation As a Novel Treatment for Dizziness in People with Multiple Sclerosis

The study aims to study the effects of a novel treatment for vestibular symptoms in people with multiple sclerosis. The main objective is to determine whether daily personalized gaze stabilization training is more beneficial than intermittent gaze stability training in people with multiple sclerosis.

People with multiple sclerosis (MS) often experience dizziness, caused by problems in how their brain processes balance signals. This dizziness can lead to difficulties keeping their eyes focused on a target while moving their head, known as gaze instability. This makes activities like walking or driving challenging and dangerous. Vestibular physical therapy, including gaze stabilization exercises, can help. The team developed StableEyes, a technology that improves gaze stability using a gradual approach to these exercises. In the studies, StableEyes significantly enhanced gaze stability in people with balance issues. Preliminary research in people with MS shows promising results, suggesting that tailored gaze stability exercises can further improve their vision stability. This method targets the vestibulo-ocular reflex (VOR), a critical reflex for maintaining clear vision during head movements. Improved VOR function can reduce dizziness and improve the quality of life for people with MS.

Eligibility Criteria:
Inclusion Criteria:

* Neurologist-confirmed diagnosis of primary progressive or relapsing and remitting MS per the 2017 Revision of the McDonald Criteria and the Magnetic Resonance Imaging in MS
* Fluent in speaking and understanding English
* Have self-reported vestibular symptoms of dizziness, imbalance, and/or a history of at least two falls in the prior 12 months

Exclusion Criteria:

* Clinically isolated syndrome or radiologically isolated syndrome.
* Worsening MS symptoms during the prior 60 days
* Immunotherapy change in the prior 60 days
* Self-reported cognitive impairment that limits independence with basic and instrumental activities of daily living
* Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 90 mmHg at rest
* Static visual acuity with correction of worse than 1.0 logMAR
* Manifest ocular misalignment ≥ 5 diopters (e.g., tropia, lazy eye, strabismus}
* Convergence insufficiency
* Intra-nuclear ophthalmoplegia
* Benign paroxysmal positional vertigo
* Major orthopedic conditions that limit cervical spine range of motion or that alter walking
* Self-reported current or potential for pregnancy during enrollment
* Ongoing participation in vestibular rehabilitation for dizziness
Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects

This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese
* Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)
* Body mass index (BMI) is ≥18.0 and \<30.0 kg/m\^2 (at screening)

Exclusion Criteria:

* Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination
* Having alcohol or drug dependence, etc.
Safety and Efficacy Study of Thalomid in Patients With Chronic Pancreatitis

The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.

Pancreatitis is an inflammation of the pancreas, a gland that lies behind the stomach. The inflammation may develop suddenly (acute pancreatitis) or over many years (chronic pancreatitis). The pancreas produces the hormones, insulin and glucagon to control metabolism. The hormones and enzymes flow from the pancreas through the pancreatic duct into the upper part of the small intestine.

Most chronic pancreatitis patients often experience chronic abdominal pain during the course of the disease. Thalidomide increased the production of interleukin-10 (IL-10), which is important in regulating intestinal inflammation. Thalidomide is approved by the Food and Drug Administration (FDA) for a leprosy skin condition, erythema nodosum lerosum (ENL), but not for the treatment of chronic pancreatitis. In this case it is considered experimental.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75, inclusive.
2. Female must be post menopausal (≥ 24 months without menses or surgically sterilized).
3. Able to comprehend English.
4. Chronic pancreatic pain lasting for more than 2 months.
5. History of chronic pancreatitis with pancreatic type pain confirmed by at least one of the following:

   * Histological confirmation
   * CT/MRI (including calcifications, dilated cuts, dilated MPD, and /or atrophy)
   * ERCP with Cambridge score of 2 or greater
6. Subject must score at least 4 cm on the VAS scale during the 1-2 week lead-in-period.
7. Patients must give written informed consent.
8. Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program.

Exclusion Criteria:

1. Female of child-bearing potential.
2. Unable to comprehend English.
3. Patients with diabetes requiring insulin.
4. Evidence of gallstones on screening ultrasonography.
5. Current alcohol abuse or addiction to opiate analgesics.
6. Patients with existing peripheral neuropathy.
7. Patients who are taking medications known to be associated with development of neuropathy: Amiodarone, hydralazine, perhexiline, vincristine, cisplatin, Metronidazole (Flagyl), Dapsone, Phenytoin and Disulfiram.
8. Patients who have pre-existing hypercoagulable state. Patients with a history of malignancy within the past 5 years, patients with a recent surgical procedure, patients with chronic immobilization causing blood stasis, patients with history of embolism or deep vein thrombosis, patients with extreme heart failure, and patients with a congenital disorder of the clotting cascade.
9. Patients with active alcoholic liver disease or elevated liver function \>3Xs the upper limit of normal.
10. Patients will be withdrawn from the study at Visit 4 (Month 3) if pain score on VAS scale has not improved.
Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy

Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.


Eligibility Criteria:
Inclusion Criteria:

* Patients under PCSK9 inhibitor treatment.

Exclusion Criteria:

* Age \< 18 years o \> 80 years;
* Patients who refuse to participate and to sign informed consent.
The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females

Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.

In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.

Eligibility Criteria:
Inclusion Criteria:

* Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants

Exclusion Criteria:

* Age
* Insufficient fitness level
* Blood donation 3 months prior to enrollment
* Altitude exposure 2 months before enrollment
* Hypertension
VR to Improve CINV, Sleep and Pain Among Children With Cancer in HK

Chemotherapy-induced nausea and vomiting, sleep quality and pain are the common symptoms experienced by children with cancer. These symptoms significantly devastate the children's quality of life. Hypnosis is found to be effective in managing chemotherapy-induced nausea and vomiting, sleep quality and pain in children with cancer. In addition, virtual reality is shown to promote the effectiveness of hypnosis in managing these symptoms. However, no study so far has examine it effectiveness in Hong Kong Chinese children with cancer. This study aims to investigate the effectiveness in the use a virtual reality device to improve chemotherapy-induced nausea and vomiting, sleep quality and pain among children with cancer in Hong Kong.

This study is a randomized controlled trial. We recruit 180 children with cancer who are aged 9 to 18 and Chinese speaking and allocate them into experimental and control group. The experimental group will receive a 15-minute hypnosis using virtual reality when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The control group will receive no intervention.

Eligibility Criteria:
Inclusion Criteria:

* Aged 9 to 18
* Can read Chinese and speak Cantonese
* diagnosed with cancer

Exclusion Criteria:

* with mental disabilities or cognitive dysfunction as identified in the medical record
The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.

The purpose of this study is to determine the efficacy and safety of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 to 80 years
2. Subjects with 7% ≤ HbA1c ≤ 10% who have been diagnosed with T2DM at least 8 weeks
3. Subjects with BMI of 20-45 kg/m2
4. Subjects who have been on a stable diet and exercise program for at least 8 weeks
5. Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study

Exclusion Criteria:

1. Different type of diabetes mellitus which is not T2DM (type 1 diabetes mellitus, secondary diabetes mellitus, or congenital renal glucosuria)
2. Symptoms of stress urinary incontinence, dysuria that is not controlled by medications due to neurogenic bladder or prostatic hyperplasia, anuria, oliguria, or urinary retention
3. Severe diabetes complications (proliferative diabetic retinopathy, nephropathy of stage 4 or higher, or serious diabetic neuropathy)
4. eGFR \< 60 mL/min/1.73 m2
5. Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
6. Uncontrolled hypertension (SBP \>180 mmHg or DBP \> 110 mmHg)
Open Label Ketamine Treatment for Major Depressive Disorder in Veterans

Medically healthy Veterans ages 21-75 that have been diagnosed with Depression will get up to 6 treatments of Ketamine infusions, weekly. After treatment is completed, follow up will occur at 1 month, 3 months, and 6 months after completion of infusions to evaluate the longer term effects of ketamine.

A total of 25 depressed subjects between the ages of 21-75 who have current major depressive disorder without psychotic features by DSM-5 will be recruited. Subjects will be accepted into the protocol after an opportunity to review and provide voluntary written informed consent and completion of a comprehensive medical and psychiatric history, physical examination, mental status examination, and routine laboratory assessments. Patients will be recruited in outpatient settings to the Refractory Depression Clinic. Providers or Refractory Depression consult team will be informed if the patient may be eligible for participation in the ketamine protocol. Subjects must have established care in the VA Connecticut Healthcare System. If the Veteran is interested, a screening visit for further evaluation for the ketamine protocol will be scheduled. Veterans will receive up to 6 infusions for ketamine weekly, per PI discretion. The primary goal of this proposal is to test the effectiveness of repeated ketamine treatment (0.5 mg/kg; once or twice a week for up to 6 weeks; up to a total of 6 ketamine infusions). An open-label trial will be conducted that will include up to 25 Veterans with MDD with a follow-up of 6 months. This open-label trial will allow us to examine the safety and tolerability of the ketamine treatment in this population and the long-term effects. All patients will receive usual standard care during this trial.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 21-75 years old
2. Current major depressive disorder without psychotic features by DSM-5
3. Montgomery-Åsberg Depression Rating Scale (MADRS) ≥ 20
4. Able to provide written informed consent

Exclusion Criteria:

1. Current or past history of psychotic features or psychotic disorder
2. Current or past history of delirium or dementia
3. Current uncontrolled hypertension (systolic BP \> 170 mm Hg or diastolic BP \> 100 mm Hg)
4. Unstable medical condition or allergy to ketamine or lorazepam---clinically determined by a physician
5. Pregnant or nursing women, positive pregnancy test, or inadequate birth control methods in women of childbearing potential
6. Positive opioid or illicit drug screen test (except marijuana)