cyrilzakka/clinical-trials huggingface dataset:
Bioimpedance Based Monitoring of Operation Wound and Skin Graft Healing

This study consists of two clinical series. With the first series investigators monitor the healing of skin grafts with bioimpedance measurements. The bioimpedance measurement is done with a purpose built patch that has electrodes in contact with the wound and reference electrodes.

In the second series the investigators monitor closed operational wounds (breast reconstruction surgery patients) with bioimpedance measurements. This series is also conducted with bioimpedance measurements but the wounds are operational wounds.

Both groups will have 20 patients.

Objectives of the study:

1. The investigators will study how bioimpedance measurement results correlate with conventional wound healing monitoring.
2. The investigators will seek the best methods for handling, interpreting and presenting bioimpedance measurement results.
3. The investigators will find out if impedance measurement is applicable to clinical use.

Eligibility Criteria:
Inclusion Criteria:

* patients that have a skin graft operation made as part of their treatment
* patients that have breast reconstruction surgery made as part of their treatment

Exclusion Criteria:

* pregnancy
* patients with limited capacity to understand the information regarding the study
* patients with chronic skin disease on operation area
Genetic Basis of Primary Immunodeficiencies

The purpose of this study is to evaluate patients with primary immunodeficiency disorders to identify patients with mutations of the genes for the following proteins: Jak3, STAT1, STAT4, interleukin-7, interleukin-7 receptor, interleukin-12 receptor subunits, and others.

Patients will undergo screening history, physical examination, and clinical laboratory evaluation at referring institutions and tissue samples, or cell lines will be sent to the NIH. We will establish cell lines if necessary, prepare DNA and RNA for molecular genetic analysis and study cytokine signal transduction in patient cell lines.

The purpose of this study is to evaluate patients with primary immunodeficiency disorders to identify patients with mutations of the genes for the following proteins: Jak3, STAT1, STAT4, interleukin-7, interleukin-7 receptor, interleukin-12 receptor subunits, and others. Patients will undergo screening history, physical examination, and clinical laboratory evaluation at referring institutions and tissue samples, or cell lines will be sent to the NIH. We will establish cell lines if necessary, prepare DNA and RNA for molecular genetic analysis and study cytokine signal transduction in patient cell lines.

Eligibility Criteria:
* INCLUSION CRITERIA:

Samples from patients with known or suspected primary immunodeficiencies, including those treated with stem cell transplants or gene correction therapy, and their families will be accepted worldwide primarily from tertiary care centers that treat patients with such immunodeficiencies.

Such patients will have documented evidence of either opportunistic infection, recurrent infection, or unusually severe responses to infectious agents that cause mild illness in unaffected individuals. In selected cases, at the discretion of the investigators, samples for testing will be obtained from consenting adult relatives of affected individuals.

Either patient-derived B cell lines or primary blood samples will be accepted although in some cases buccal swabs will also be accepted.

Blood samples may be obtained from unaffected children.

Additionally; patients with particularly interesting clinical presentations (e.g. adults with possible attenuated immunodeficiency) may be seen for outpatient visits at the NIH Clinical Center for evaluation.

Infants with SCID or other primary immunodeficiency will not be seen; their physicians will care them for and only clinical material will be sent on such patients.

Medically stable patients with mild to moderate immunodeficiency may be seen at the NIH.

We will encourage the participation of women and members of minority groups in this study.

EXCLUSION CRITERIA:

Inability to provide informed consent.

A presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.

To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer aged 65-80 years old
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Subjects with symptoms or signs of adrenal insufficiency.
* Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
How Does the Type of Waveform Affect Tolerability With Transcutaneous Auricular Vagus Nerve Stimulation?

The purpose of this research study is to investigate the effects of different forms of a gentle form of electrical stimulation applied to the ear, known as transcutaneous auricular vagus nerve stimulation (taVNS). The research team is interested in how the different forms affect comfort and tolerability, as well as how well it works.


Eligibility Criteria:
Inclusion Criteria:

1. between the ages of 18-80 years
2. English speaking (must be able to consent and complete the interviews in English)

Exclusion Criteria:

1. chronic pain (average intensity \&gt;2/10 on 0-10 scale, for longer than 3 months)
2. acute pain of intensity greater than 3/10
3. chronic inflammatory conditions that are poorly controlled (e.g., diabetes, autoimmune disease)
4. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia)
5. pregnancy
6. currently taking Buprenorphine or recently stopped taking (within 1 month)
7. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews
8. implants in the head or neck, cochlear implants, or pacemaker
9. head or neck metastasis or recent ear trauma
10. history of epilepsy
11. history of autonomic nervous system dysfunction (e.g., postural orthostatic tachycardia syndrome).
Efficacy and Safety of Imipenem+Cilastatin/Relebactam (MK-7655A) in Japanese Participants With Complicated Intra-abdominal Infection or Complicated Urinary Tract Infection (MK-7655A-017)

The study will evaluate the efficacy and safety of imipenem+cilastatin/relebactam (IMI/REL, MK-7655A) in Japanese participants with complicated intra-abdominal infection (cIAI) or complicated urinary tract infection (cUTI).


Eligibility Criteria:
Inclusion Criteria:

* requires hospitalization and treatment with IV antibiotic therapy for complicated intraabdominal infection (cIAI) or complicated urinary tract infection (cUTI). Per-protocol diagnostic criteria apply to the qualifying infection types.
* infection is known or thought to be caused by microorganisms susceptible to the IV study therapy
* baseline specimen for primary infection site culture obtained at operative procedure in Screening period or at Baseline for cIAI participants, and within 48 hours before initiation of IV study drug for cUTI participants
* female or male who is not of reproductive potential, or female or male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner from the time of consent through completion of the study, by practicing abstinence from heterosexual activity or using acceptable contraception during heterosexual activity.

Exclusion Criteria:

* received any amount of effective antibiotic therapy after obtaining the culture for admission to the study and before administration of the first dose of IV study therapy
* received treatment with systemic effective antibiotics for \>24 hours within the 72 hours before initiation of study therapy
* has a concurrent infection, including endocarditis, osteomyelitis, meningitis, or prosthetic joint infection, that would interfere with evaluation of response to IMI/REL
* has a cIAI or cUTI due to a confirmed fungal pathogen
* has a cUTI that meets any of the following: 1) complete obstruction of any portion of the urinary tract, 2) known ileal loop, 3) intractable vesico-ureteral reflux, 4) presence of indwelling urinary catheter which cannot be removed at study entry
* has a cIAI that meets any of the following: 1) infection that should be managed by Staged Abdominal Repair (STAR) or open abdomen therapy, 2) infection limited to the hollow viscus
* history of serious allergy, hypersensitivity, or any serious reaction to any carbapenem, cephalosporin, penicillin or other beta-lactam agent, or other beta-lactamase inhibitors
* female who is pregnant or is expecting to conceive, is breastfeeding, or plans to breastfeed before completion of the study
* history of a seizure disorder
* anticipates to be treated with valproic acid, concomitant IV or an oral antimicrobial considered effective to the index pathogen, in addition to the study treatment
* is receiving immunosuppressive therapy, including high-dose corticosteroids
* is undergoing hemodialysis or peritoneal dialysis
* participated in any other clinical study involving an investigational or experimental medication during the previous 30 days before Screening.
Efficacy of Metformin in Preventing Diabetes in China

A multicentred, randomized, open study to evaluate the efficacy of metformin in preventing Diabetes.

The increasing prevalence of prediabetes had been documented in the recent national surveillance in China. Prediabetes is an important risk factor for developing overt Diabetes and macro/micro vascular diseases. Pharmaceutical medications such as metformin had been proved effective in preventing Diabetes. Local studies are in need to guide the clinicians in their daily practice to prevent Diabetes in China. Therefore, China Diabetes Prevention Program（China DPP）is designed and conducted to compare the efficacy of metformin combined with lifestyle intervention versus lifestyle intervention alone in preventing Diabetes.

Eligibility Criteria:
Main Inclusion Criteria:

1. Diagnosis of IGR before the randomization based on the 1999 WHO diagnostic and classification criteria.
2. Age: 18 ≤age≤70 years old.
3. Not on a treatment of anti-diabetic agents, including Chinese traditional herbs lowering blood glucose for at least 6 months before screening.
4. Male or non-pregnant, non-breastfeeding females, females without birthing plan in next three years.
5. Body mass index (BMI) ：21 kg/m2 ≤BMI\<32 kg/m2.
6. Written informed consent given before any trial-related activities are carried out.

Main exclusion Criteria:

1. Administration with medications for pre-existed diseases affect glucose metabolism (except thiazide diuretics when its daily dose≤12.5mg).
2. Administration with anti-obesity agents (including Chinese traditional medicine) within 6 months of enrolment and during intervention.
3. Administration with three or more than three types antihypertensive drugs.
4. Diabetes patients (subjects with prior history of gestational Diabetes will not be excluded).
5. Have any of the following cardiovascular conditions within 3 months prior to the screening visit: acute myocardial infarction, congestive heart failure defined as New York Heart Association class III/IV or left ventricular ejection fraction ≤40%,) or cerebrovascular accident.
6. Persistent uncontrolled hypertension (systolic blood pressure ≥160mmHg, or diastolic blood pressure ≥100 mmHg).
7. Impaired liver function, have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, ALT or AST levels ≥3 times the upper limit of the reference range at the screening visit.
8. Renal dysfunction (eGFR\<45ml/min）.
9. Patients ventilated by ventilator.
10. Hypersensitivity to metformin or to any of the excipients such as povidone K 30, magnesium stearate and hypromellose.
11. Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic respiratory disease).
12. Acute alcohol intoxication, alcoholism.
13. Severe chronic gastrointestinal disease.
14. Severe psychiatric illness.
15. Cancer requiring treatment in past 5 years.
16. Uncontrolled thyroid diseases.
17. Women who are pregnant or breastfeeding .
18. Participation in another clinical trial within the past 30 days .
19. Other significant disease that in the Investigator's opinion would exclude the subject from the trial.
A Study to Assess the Safety and Efficacy of an Investigational Drug (MK-686) in Patients With Osteoarthritis (0686-006)

This study is being conducted to assess the safety and tolerability of MK-0686 and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee,either prior NSAID or Acetaminophen users within the ARA functional class I,II or III and with no clinically significant diseases
* Patients required to demonstrate a flare of the signs and symptoms of OA following withdrawal of NSAID treatment
* Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA
* females must be either post-menopausal or surgically sterilized

Exclusion Criteria:

* No history of concurrent arthritic disease
* No history of neoplastic disease within a specified duration
* No history of disease that causes malabsorption
* Chronic use of certain medications excluded
Dose Ranging Study

Dose Ranging Study


Eligibility Criteria:
Inclusion Criteria:

\>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI \<30 kg/msq Stable diet and exercise and body weight

Exclusion Criteria:

Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs
The Effects of Epinephrine in Endotoxemia in Normal Volunteers

Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.

The body's immune response to injury otr infection is very complex. immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to epinephrine and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Eligibility Criteria:
Inclusion Criteria:

* General good health as demonstrated by medical history, physical\& laboratory tests
* Age between 18 and 40 years
* Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Any medication taken in past 48 hrs (except birth control)
* Recent history of alcohol or drug abuse
* Unable to provide written informed consent
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnant or breast-feeding
Remote Symptom Monitoring on Patient-Reported Outcomes With Nudge Strategies Among Patients With Tumor in China

The goal of this clinical trial is to design a digital PRO intervention model applicable to patients with hepatocellular carcinoma, and The main questions it aims to answer are:

* Can symptom management through patients' regular completion of the PRO scale promote self-understanding, self-management and timely seeking of medical help, enable healthcare professionals to accurately and efficiently understand how patients really feel and respond in a timely manner, and ultimately improve health outcomes?
* Can digital interventions significantly improve outcomes such as symptom control and quality of life in cancer patients? Researchers divided participants into an intervention group and a control group and compared them to see if digital interventions could improve patient health outcomes.

Participants will:

* Subjects in the intervention group will be asked to report symptom information weekly (7-day natural week, hereafter) via the public number, and the back office will give symptom management advice or issue alerts based on the filling. Control subjects will not receive PRO intervention.
* Participants can offer to withdraw from the study at any time.


Eligibility Criteria:
Inclusion Criteria:

1. The patients are aged between 18 and 75 years old;
2. The patients have been diagnosed with locally advanced or metastatic liver cancer through pathological or imaging examinations;
3. The patients are currently receiving or have completed PD-1 monotherapy or PD-1 combination therapy;
4. The patients can participate in this study as per the requirements of the research protocol;
5. The patients voluntarily sign the informed consent form.

Exclusion Criteria:

1. The patients have cognitive impairment or are unable to clearly identify their own symptoms and feelings;
2. The patients are illiterate or unable to understand the research content for other reasons;
3. The patients are currently participating in other clinical trials that may affect this study.
Brief Chemoimmunotherapy With R+B+M Followed by R in Elderly Patients Advanced Stage Untreated Follicular Lymphoma

This is a prospective, multicenter phase II trial designed to determine efficacy and safety of a brief chemoimmunotherapy with the combination of Rituximab + Bendamustine + Mitoxantrone in elderly patients with advanced stage Follicular Lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven diagnosis of B-cell CD20+ follicular NHL, grade I, II and IIIa of WHO Classification
* Untreated patients with the exception of prior limited radiotherapy
* Stage III or IV who require therapy according to SIE and GELF criteria
* Stage II with at least one of the following:

  * Bulky disease (\>7 cm)
  * LDH \>normal
  * Systemic symptoms
  * Beta2-Microglobulin \>3 mg/l
  * Extra-nodal involvement
  * Active disease with rapid progression 5.Age from 65 to 80 years, geriatric score "FIT" (see Appendix B) 6.Life expectancy \>6 months 7.ECOG performance status 0-2 (see Appendix C) 8.LVEF ≥45% or FS ≥37% 9.ANC ≥1 x 109/l and Platelets count ≥75 x 109/l, unless due to bone marrow involvement by follicular lymphoma 10.Creatinine up to 1.5 x ULN 11.Conjugated bilirubin up to 2 x ULN 12.Alkaline phosphatase and transaminases up to 2 x ULN 13.Sending of bone marrow sample for Bcl-2/IgH rearrangement evaluation 14.Written informed content

Exclusion Criteria:

* Men not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
* History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
* Medical condition requiring long term use (\>1 months) of systemic corticosteroids
* Active bacterial, viral, or fungal infection requiring systemic therapy 5. Concurrent medical condition which might exclude administration of therapy
* Cardiac insufficiency (NYHA grade III/IV; see Appendix D)
* Myocardial infarction within 6 months of entry on study
* Severe chronic obstructive pulmonary disease with hypoxemia
* Severe diabetes mellitus difficult to control with adequate insulin therapy
* Hypertension that is difficult to control
* Impaired renal function with creatinine clearance \<30 ml/min (see Appendix E)
* HIV positivity
* HBV positivity with the exception of patients HbsAg negative and Ab anti-Hbcore positive (these patients need to receive prophylaxis with Lamivudine)
* HCV positivity with the exception of patients with no laboratory signs of active chronic hepatitis and HCV-RNA negativity
* CNS involvement by lymphoma 16. Participation at the same time in another study in which investigational drugs are used
* Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
* Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
Effects of Acute Intake of Caffeinated Beverages in Type 1 Diabetes

The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes.

Knowledge acquired may inform a wider study of the impact of these drinks.

This is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study.

The study will consist of 3 phases, each lasting 3 days. A different study drink will be administered during each phase. There will be an initial screening visit and a pre- study visit before each study phase. Each participant will make 10 visits to the research centre.

There will be a week wash out period between each study phase. Prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period.

Study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. Administration of the study drink to participants will be based on Latin squares to provide a balanced treatment order.

During the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries.

The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥18 years
* Confirmed diagnosis of Type 1 diabetes of more than one year duration
* Participants who use multiple daily injections of basal and meal-time analogue insulin.
* Ability to perform daily finger stick measurements of blood glucose levels
* Adequate contraceptive control
* Provision of informed consent

Exclusion Criteria:

* Hypoglycaemia unawareness
* Coronary heart disease
* Cardiac arrhythmia
* Structural heart lesions,
* Autonomic neuropathy
* Psychiatry illness,
* Epilepsy
* Migraine
* Caffeine intolerance
* Unable to provide informed consent