cyrilzakka/clinical-trials huggingface dataset:
Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System

Myocardial infarction is related with endothelial function, arterial stiffness and autonomic nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is also related with endothelial function, arterial stiffness and autonomic nervous system dysfunction.

Primary aim of study is to investigate how complex cardiac rehabilitation influence endothelial function, arterial stiffness and autonomic nervous system activity according to presence or absence arterial hypertension.

Secondary aim is to obtain correlation between methods for the assessment of particular disorders and intercorrelation between different disorders for example endothelial function and autonomic nervous system activity.

We expect that in study groups PWV will improve better that in control group. 5% of the limit value of p \<0.05.

We expect that in study groups AASI will improve better that in control group. 5% of the limit value of p \<0.05.

We expect that in study groups AI will improve better that in control group. 5% of the limit value of p \<0.05.

We expect that time and frequency parameters of HRV will increase in study group. 5% of the limit value of p \<0.05.

We expect that parameters of HRT will improve in study group. 5% of the limit value of p \<0.05.

We expect improvement in RHI in study group. 5% of the limit value of p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* after a recent troponin-positive acute coronary syndrome (within 7-30 days) treated by means of primary coronary angioplasty,
* age 20-85 year old,
* accepted and sign informed consent,

Exclusion Criteria:

* unstable coronary artery disease,
* indications for a coronary artery bypass graft (CABG),
* peripheral artery disease,
* uncontrolled arterial hypertension,
* ventricular and supraventricular arrhythmias in excess of 10% of all the evolutions throughout the day,
* allergy to latex,
* deformities or condition after the amputation of fingers,
* body mass index (BMI) above 35 kg/m2,
* a significant hepatic or renal failure,
* infectious disease.
Efficacy and Tolerability of Nolotil i.v. vs. Placebo i.v. in the Prevention of Postoperative Pain in Children Undergoing Minor Surgery

Study to assess the analgesic efficacy in the prevention of postoperative pain in children undergoing minor surgery (herniorraphy, tonsillectomy) and to assess the tolerability of Metamizol in this group of patients.


Eligibility Criteria:
Inclusion Criteria:

* Children of either sex between 6 and 11 years of age
* Patients undergoing routine inguinal hernia repair or tonsillectomy
* Written informed consents by the guardian, according to the guidelines of Good Clinical Practice and current legislation
* The ability of the patient to understand and carry out the visual analogue scale assessments
* Patients with a physical status American Society of Anesthesiologist I or II class

Exclusion Criteria:

* The use of any drug with analgesic properties in the 24 hours prior to the administration of the study drug
* Surgery with a foreseen duration over 60 minutes
* Patients with a nutritional index of less than 90 or greater than 120
* Patients with a body mass index which was not between the 3rd centile and the 97th centile for age
* Patients with any illness or malformation (except hernia) which, in the doctor's opinion, contraindicated the use of metamizol (aplastic anemia, agranulocytosis of a toxicological etiology, severe renal disease, etc.)
* Patients who have received in the previous 7 days or need currently anticoagulant treatment
* Significant allergy or known hypersensitivity to metamizol, its excipients and/or to other nonsteroidal antiinflammatory drugs
* Patients in whom the anesthetic regimen required by the protocol cannot be used
* Patients who have participated in another clinical trial in the past four weeks or are currently participating in another clinical trial
* Patients with any psychological disturbance which, in the investigator's opinion makes the patient unsuitable for inclusion in the trial
Study of NPO-13 During Colonoscopy

This study will investigate the safety, efficacy and dose-response of NPO-13 in subjects with moderate to severe colonic spasm during colonoscopy. An intraluminal spraying of NPO-13 dosed up to twice into ascending or sigmoid colon. The colonic spasm will be assessed by an independent committee using recorded video images. The study consists of a screening visit window, 1-day treatment phase and 1-week follow-up phase.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who are between 20 and 85 years at the time of consent
2. Patients who need colonoscopy

Exclusion Criteria:

1. Patients with a history of abdominal surgical treatment (including the laparoscopic surgery) including the gynecology operation
2. Patients with contraindication to colonoscopy including the paralytic ileus
3. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil (mint oil)
4. Patient with contraindication to bowel cleansing preparation
5. Patient with contraindication to pain medicine and sedative medicine
6. Patient with contraindication to butylscopolamine bromide and glucagon
7. Patients on cancer treatment (chemotherapy or radiotherapy)
8. Patient with active inflammatory bowel disease or infectious enteritis
9. Patients who need sedative in colonoscopy
10. Patients who receives a therapeutic colonoscopy
11. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
12. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
13. Patients otherwise ineligible for participation in the study in the investigator's or coinvestigator's opinion
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia

Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.

Bacterial and fungal infection treatment is well defined with guidelines. Few data are available for viral infections and concern essentially allogeneic stem cell transplantation. These infections are associated with a high mortality and morbidity rate. Data concerning AML are essentially retrospective, pediatric and with a little number of patients. Respiratory viral infections incidence is not known. These infections may be responsible for a higher mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia, co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral therapy. This study aims at understanding viral infections epidemiology during long term aplasia and optimizing their management.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included.
* Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study
* Patients who have signed a consent policyholder

Exclusion Criteria:

* patients under 18 years old
* patients treated with another treatment than induction and consolidation chemotherapy
* pregnant women
* patients HIV, HBV or HBC positive
* patients with a positive PCR at J1
* patients treated with an antiviral treatment or an immunosuppressive treatment for another pathology
* patients under guardianship
* Primitive immunity Deficit
Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery

This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery

PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation data during RALP to guide us in deciding whether and how the mechanical manipulation of the TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo TRUS during RALP. After the completion of study treatment, patients are followed up at 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing Robotic Assisted Laparoscopic Prostatectomy

Exclusion Criteria:

* Known or discovered rectal pathology
* Bleeding hemorrhoids
* Rectal stenosis
* Any prior rectal surgeries
* Prior rectal radiation
* Any known rectal disease
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* subject receiving a primary, partial liver graft from a living donor
* subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined

Exclusion Criteria:

* subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
* subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
* subjects allergic or intolerant to macrolide antibiotics or tacrolimus
* subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
* subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
* subjects with systemic infection requiring treatment, except viral hepatitis
* subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
* subjects with serum creatinine \> 1.5mg/dl
* subjects taking or having taken potassium preserved diuretics
* subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
* subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
* subjects or donors known to be HIV positive
* donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV
Study Using CP-461 to Treat Advanced Prostate Cancer

The purpose of this study is to investigate whether an investigational drug, CP-461, is safe and effective for the treatment of patients with prostate cancer and who have measurable disease.


Eligibility Criteria:
Eligibility Criteria:

* Male 18 years of age.
* Histologically confirmed adenocarcinoma of the prostate, stage D1 or D2.
* Failure of androgen ablation (orchiectomy or LHRH, flutamide).
* Patients must have PSA progression and progression in measurable disease.
* No prior history of systemic chemotherapy.
* No investigational drugs within 4 weeks of study entry.
* No radiation therapy or hormonal therapy within 4 weeks of study entry.
* No isotope therapy within 6 weeks of study entry.
* No antiandrogens within 4 weeks of study entry. Patients must continue LHRH.
* If patients had prior surgery, it must be at least 21 days prior to study entry, and the patient must have recovered from all side effects.
* Patients must have stopped bisphosphonates 28 days prior to study entry.
* No prior malignancy allowed except for adequately treated basal cell or squamous cell skin cancer, or adequately treated stage I or II cancer from which the patient is currently in remission, and has been disease free for at least 5 years.
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator not have significant active concurrent medical illness, such as a history of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude protocol treatment or survival.
* All patients must be informed of the investigational nature of the study and must sign and give written informed consent in accordance with institutional and federal guidelines.
* No other chemotherapeutic, biological response modifiers, radiation therapy, corticosteroid therapy, or hormonal concomitant therapy (except continuation of LHRH) may be given during treatment. Patients should not be planning on receiving concomitant bisphosphonates.
* ECOG Performance Status = 0-3.
* WBC \> or = 3500/ul or ANC \> or = 1500/ul.
* Bilirubin \< or = ULN.
* Creatinine \< or = 2.0 mg/dl.
* Platelets \> or = 100,000/ul.
* ALT or AST \< 2.5 X ULN.
Complications of Enterocystoplasty in Children

The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question\[s\] it aims to answer are:

* what kind of complications are there
* the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.

Complications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

* patients who underwent a enterocystoplasty after 18 years old
A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults

The potential health effects of high intake of lean or fatty fish will be investigated in overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.

Hypothesis:

High intake of fatty or lean fish will beneficially affect glucose regulation and the immune system.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥27 kg/m2
* fasting blood glucose ≤7.0 mmol/L

Exclusion Criteria:

* pregnancy
* incompatibility with fish consumption (allergies, intolerance and/or dislike)
* diagnosed diabetes mellitus, heart disease or gastrointestinal diseases
* use of medications affecting lipid metabolism or glucose homeostasis
* use of anti-inflammatory medications
* use of supplements containing long chain n-3 fatty acids
* intentional weight loss
* and large fluctuation in body weight (\>3 kg) over the previous two months
Pediatric Decentralization of ART in South Africa

The decentralization study will describe children taking antiretroviral therapy (ART) at a larger health facility in the Eastern Cape province of South Africa, between the years of 2004-2013. The study will be conducted at Dora Nginza Hospital (DNH). The study will measure how many children stay in care and how many die, as well as their health status. The study will also compare whether children do better if they stay in care a large hospitals or if they get health care at smaller clinics. A second part of the study will find children in the community who have stopped coming for health care and find out what happened to them and what their health status is.

The investigators propose to conduct a two part study which will include a retrospective cohort study to examine care outcomes among pediatric patients 0-14 years of age initiated on antiretroviral therapy (ART) in 2004-2013 at a larger peri-urban health facility in the Eastern Cape province of South Africa. The study will be conducted at Dora Nginza Hospital (DNH). The outcomes measured in the study will include retention and mortality, as well as virologic suppression rates for children initiated on ART. In addition to reporting outcomes for all children with available data, the study will compare outcomes for children retained in care at DNH (where they initiated ART) to those children who were referred out after initiation for routine follow-up at community health clinics and primary care clinics ("down referred"). A second part of the study will trace pediatric patients in the community who have been lost to follow-up (LTF) to ascertain their outcomes after they left care at the health facility.

Eligibility Criteria:
ART Outcomes Study:

Inclusion Criteria:

* HIV positive; less than 15 years of age; started ART at DNH between 2004 and 2013.

Exclusion Criteria:

* Anyone not meeting inclusion criteria

Tracing Study:

Inclusion Criteria:

* Legal caregiver (older than 18) a child who was included in the ART Outcomes Study that was found to be LTFU from DNH or from the down-referral facility.

Exclusion Criteria:

* Guardians who cannot be confirmed as the legal caregiver of the child
A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy Volunteers

Demonstrate the bioequivalence of a serum-free solution to a serum containing solution of Avonex.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteers

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions
* History of hypersensitivity to acetaminophen (paracetamol), ibuprofen, or codeine.
* Known allergy to dry natural rubber
* History of seizure disorder or unexplained blackouts
* History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease

Other inclusion and exclusion criteria apply as per protocol
Enamel Remineralization Potential of Dentifrices in Situ

This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.


Eligibility Criteria:
Inclusion Criteria:

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
* No current active caries or periodontal disease that may compromise the study or health of the subject.
* All restorations in a good state of repair
* Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
* Willing to have their denture modified to accomodate enamel test specimens
* Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
* Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

Exclusion Criteria:

* Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
* Current active caries or periodontal disease that may compromise the study or health of the subject.
Stress, Emotion Regulation, and Alcohol in Women Veterans

The purpose of the study "Stress, Emotion Regulation, and Alcohol in Women Veterans" is to learn about the effects of negative emotion and stress on behavior (including alcohol use) among women Veterans, including women with and without posttraumatic stress disorder. Additionally, the study looks at whether a woman's use of emotion regulation techniques changes the association between stress or negative emotion and behavior. Lastly, the study examines how women's reactions to stress, and the effects of stress, vary across the menstrual cycle - depending on the level of circulating hormones.

Aims for the current study are two-fold: 1. conduct a randomized trial testing the effects of an emotion regulation skill (cognitive reappraisal) on stress-induced drinking among women with alcohol misuse and varying levels of co-occurring PTSD; 2. examine whether progesterone levels and/or severity of co-occurring PTSD - factors which impact women's stress reactivity and emotion regulation - moderate the effectiveness of the cognitive reappraisal in reducing stress-induced drinking.

The proposed study will combine experimental, in-person sessions with daily self-report data from the Veterans to assess the effect of cognitive reappraisal on alcohol craving, cognitive (inhibitory) control, physiological arousal (HRV), and alcohol use. Participation will take place across a period of at least 35 days, to encompass an entire menstrual cycle. All participants complete all sections of the study - the experimental sessions and the longitudinal (35-day) data collection.

Eligibility Criteria:
Inclusion Criteria:

* Current alcohol misuse, defined as scoring 3 or higher on the AUDIT-C
* If using other illicit substances, alcohol is their primary substance of use
* Alcohol use in the past 45 days
* Able to write and speak in English
* Served in the U.S. Military
* Willing to provide blood samples at laboratory sessions to assay hormone levels and take urine ovulation tests at home

Exclusion Criteria:

* Psychotic symptoms or uncontrolled Bipolar Disorder (screened for during session 1 using SCID-5 screening modules)
* Brain damage or were in an accident that affects ability to complete the computerized task
* Current (past 3 months) active suicidal ideation or intent
* Current pregnancy