cyrilzakka/clinical-trials huggingface dataset:
Growth and Tolerance of Young Infants Fed Infant Formula

This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-based infant formulas.


Eligibility Criteria:
Inclusion Criteria:

* Participant is judged to be in good health as determined from participant's medical history.
* Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
* Participant's birth weight was \> 2490 g (\~5 lbs. 8 oz.).
* Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
* Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
* Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
* Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
* Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.

Exclusion Criteria:

* An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
* Participant participates in another study that has not been approved as a concomitant study.
Effectiveness of KneeMD on Flexion Contracture in Total Knee Arthroplasty Patients

The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative flexion contracture.

Postoperative flexion contracture (FC), defined as \>10°, is the most common disabling early complication of primary total knee replacement (TKR) surgery, affecting up to 6% of all subjects. A knee flexion of 65° is required to walk, 70° is needed to lift an object from the floor, 85° to climb stairs, 95° for optimal sitting and standing, and 105° to tie shoelaces. With growing subject and physician expectations for function and range of motion (ROM) after surgery, FC complications have become an early measure of success in TKR surgery.

The purpose of this study is to evaluate the effect of the KneeMD subject-controlled knee rehabilitation device on the incidence of postoperative FC. The primary endpoints are the preoperative change in active range of motion (AROM) and the incidence of postoperative FC at 2 weeks. Secondary endpoints include the change in AROM in subjects with postoperative FC.

Eligibility Criteria:
Inclusion Criteria:

1. Measurable Knee Flexion Contracture, with deficit limiting Active Range of Motion (AROM) and Passive Range of Motion (PROM) by at least - 10°
2. 18 years of age and older
3. Able to understand informed consent and willingness to conform to trial responsibilities

Exclusion Criteria:

1. Previous surgical treatment of knee, including tibial osteotomy
2. Botulinum Toxin Treatment within the last four months
3. Mechanical joint impingement
4. Neuromuscular pathologies such as epilepsy
5. Treatment with quinolone, antibiotic medication
6. Pregnant or nursing
7. Fractures
8. Osteomyelitis or any orthopedic infection
9. Extensor mechanism dysfunction
10. Knee joint neuropathy
11. Previous Stroke or Brain Injury
A Network & Dyad HIV Prevention Intervention for IDU's - 1

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention.

The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Eligibility Criteria:
Inclusion Criteria:

(i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

Exclusion Criteria:

* Not concurrently enrolled in another HIV prevention intervention
Hemorrhoid Artery LigatioN Without Doppler Trial

Hemorrhoidal artery ligation with Doppler guidance (HAL) and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.

The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.

In this ongoing randomized, controlled, single center clinical study 200 patients randomly divided into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity (VAS), treatment satisfaction (1 to 5 points) and need for the drug therapy in 30 days and 8 weeks after surgery.

Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.

Hemorrhoidal disease (HD), in its different manifestations, is not only the most frequented grounds of referring for medical attention, but also one of the reasons for the modest deterioration in the quality of life that can possibly result in temporary or permanent reduction of work capacities. Today, the doppler-guided dearterialization of hemorrhoidal arteries and the following suture-fixation mucopexy in the anal canal (synonyms: mucopexy, hemorrhoids lifting, HAL-RAR) is one of the most popular and actively studied methods of the stage II - III hemorrhoidal disease surgical treatment. A number of publications raise an issue whether it is really necessary to use a doppler while the localization of the hemorrhoidal arteries is typical in the vast majority of the observations and can be easily determined on palpation.

The aim of the study is to compare the direct and long-term results of the II - III grade HD surgical treatment with the use of two techniques of the suture ligation of the hemorrhoidal arteries with mucopexy. One of these methods is classic and widely known HAL-RAR, the other one has a principal differ in no-using the doppler to find the arteries, the surgeon defines them on palpation.

The hypothesis of the study is that the digital detection of hemorrhoidal arteries pulsation followed by suture ligation and mucopexy may be no less effective in the treatment of grade II - III hemorrhoids than the use of a doppler guide.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic grade II and III hemorrhoids according to Golligher.
* No other source of anal bleeding than hemorrhoids due to total colonoscopy
* Written voluntary informed consent

Exclusion Criteria:

* Any previous hemorrhoid surgery (including mini invasive procedures)
* Anal fistula
* Chronic anal fissure with severe spasm of anal sphincters
* Any stage colorectal cancer
* Oral anticoagulants for congenital disorders of the coagulation system
* Pregnancy
Improving Retreatment Success (IMPRESS)

This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB, among patients previously treated for TB. The primary objective is to determine if a moxifloxacin-containing regimen, substituting moxifloxacin for ethambutol, of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the duration of TB treatment.

Intervention Arm :12 months (6 months treatment + 12 months post treatment follow up) Control Arm :12 months (6 months treatment + 12 months post treatment follow up) Total sample size is 330.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age
* Previous history of anti-TB chemotherapy
* HIV status: HIV infected and uninfected patients are allowed in the study:
* All patients must agree to HIV testing to confirm HIV status.
* Patients already on ARVs will be allowed in the study provided that the ART regimen is not contraindicated with any of the study agents .
* HIV infected patients at any CD4 count irrespective of ART commencement and duration will be included in the study
* Smear positive or Gene Xpert positive pulmonary tuberculosis
* Rifampicin susceptible as determined by Gene Xpert at screening. Gene Xpert will be used to determine rifampicin resistance, hence the study team will made aware of resistance within 48 hours and prior to study enrolment.
* Karnofsky score greater than 70
* Female candidates of reproductive potential must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an Intrauterine Device (IUD), or hormone-based contraceptive)
* A negative pregnancy test
* Laboratory parameters done at, or 14 days prior to, screening:

  * Haemoglobin level of at least 7.0 g/dL
  * Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal
  * Serum total bilirubin level less than 2.5 times upper limit of normal
  * Creatinine clearance (CrCl) level greater than 60 mls/min
  * Platelet count of at least 50 x109cells/L
  * Serum potassium greater than 3.0 mmol/L

Exclusion Criteria:

* Patients on a Nevirapine (NVP)-containing ART regimen at screening
* Pregnant or breastfeeding
* Received an antibiotic active against M. tuberculosis in the last 14 days (e.g. fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
* Patients with known M. tuberculosis resistance to any of the study drugs at screening
* History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment.
* Known allergies or intolerance to any of the study drugs.
Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia

To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.

Recovery time of postoperative anesthesia is an important index to reflect patient's postoperative health status. The investigators want to collect patients' clinical dates and their blood samples, then extract DNA from blood samples, acquire every patients' genetic variation information. Finally, acquiring the mathematical model of the influence of clinical factors and genetic factors on the recovery time after operation, predicting the recovery time of anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. Aged more than 18 years;
2. General anesthesia for all patients;
3. Patients underwent surgery for laparoscopic surgery, orthopedics surgery or open surgery;
4. Patients were not delivered allogeneic blood in three months;
5. Having the ability to understand and sign the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Having an immune deficiency, as a patient with HIV infection;
3. Patients with infectious diseases, such as syphilis;
4. Patients delivered allogeneic blood in three months;
5. Researchers believe that may increasing the risk of subjects or interfering clinical trial;
6. Don't have the ability to understand or sign the informed consent.
"VIBRATIONS" - A Study In Smokers Who Are Willing And Motivated To Stop Smoking With The Aid Of Varenicline Which Will Be Prescribed According To Usual Clinical Practice In Germany

The aim of this study is to determine the success rates for stopping smoking with varenicline in Germany. The main measure of success will be continuous abstinence from smoking (not a single puff) in the last week of the standard 12 week treatment period. Additional information will be gathered regarding prescribing practices in Germany, smoking history, reasons why smokers quit smoking and re-start smoking, smoking related illnesses and the tolerability of varenicline.

Sampling Method Details: Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.

Eligibility Criteria:
Inclusion Criteria:

* Legal adult age
* Regular smoker, with main tobacco product smoked being cigarettes, and willing and motivated to stop smoking
* Evidence of a personally signed and dated Informed Consent document.

Exclusion Criteria:

* Any subjects considered unsuitable according to the Summary of product characteristics (SmPC)
Evaluation of the PneumRx Lung Volume Reduction Coil to Treat Emphysema

The objective of this study is to demonstrate the safety of the PneumRx Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is a used as a less invasive alternative to lung volume reduction surgery. The PneumRx LVRC is designed as an alternative to lung volume reduction surgery, potentially achieving the desired reduction in lung volume limiting the risks associated with major surgery, such as illness or death. This device is deployed through a bronchoscope and requires no incision.


Eligibility Criteria:
Inclusion Criteria:

* Patient \> 35 years of age
* unilateral or bilateral emphysema
* Patient has stopped smoking for a minimum of 8 weeks
* Read, understood and signed the Informed Consent form

Exclusion Criteria:

* Patient has a history of recurrent clinically significant respiratory infection
* Patient has an inability to walk \>140 meters
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has clinically significant bronchiectasis
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies with 30 days prior to this study
* Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
French Study in Real Life Evaluating Xybilun

Collecting Xybilun (Viagra's generic) efficacity, tolerance, convenience and patients/doctors satisfaction's data at different doses (50-75-100 mg), is the aim of the study.

Study design

Population Patients without prior treatment with a first Xybilun prescription Patients already treated for who the treatment is remplaced by Xybilun

Study perimeter 400 patients 50 investigators (sexologists, urologists)

Eligibility Criteria:
Inclusion Criteria:

* Age \> or equal 18 years
* Erectile dysfunction at V1 light (group 1), moderate (group 2), severe (group 3): IIEF-6 score between 6 and 25 (IIEF-6 questions 1-5 and question 15)
* More than 3 sexual intercourse
* First prescription of Xybilun (gr 1,2,3) or subtitution (gr 4)
* Information and non-opposition

Exclusion Criteria:

* Sildénafil hypersensitivity
* Treatment with nitrogen oxide or guanylate cyclase
* Patient with sexual intercourse prohibited
* NOIANA
* Alpha-blocker during past 3 months
* Norvir
* Participation in an other clinical trial
* Patient unable to read properly an information sheet
* Patient under guardianship/curatorship
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration

This study is an open label randomized clinical trial that comparing intradialytic blood pressure slope-based ultrafiltration prescriptions to standard care in the chronic fluid management of maintenance hemodialysis patients. It also includes a cross sectional component evaluating the associations between intradialytic blood pressure slopes ascertained over 2 week periods with measurements of extracellular water/body weight obtained with multifrequency bioimpedance spectroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* End Stage Renal Disease on Maintenance Hemodialysis
* Hypertension defined as systolic blood pressure \> 140 mmHg pre-dialysis or \>130 mmHg post dialysis

Exclusion Criteria:

* Hemodialysis Vintage \< 1 month
* Pregnancy
* Nadir Systolic Blood Pressure \< 95 mmHg
* Pre or Post dialysis systolic blood pressure \> 180 mmHg
* Decrease in systolic blood pressure \>60 mmHg from pre to post dialysis
* Ultrafiltration rate \>13 mL/kg/hr
* Peridialytic Midodrine Use
* Intradialytic Clonidine use
* Documented Antihypertensive Medication Non-adherence

Bioimpedance will not be peformed on patients with

* amputated arms or legs
* cardiac defibrillator or pacemaker
* presence of metal prostheses
Automatized "Semi-Whole-Body"-MRI Protocol for Cancer Staging

The aims of this study are

* to evaluate the image quality and robustness of a whole-body MRI protocol by using an innovative partially automatic algorithm (DOT engine), that automatically optimizes protocol parameters depending on body region (e.g. thorax versus abdomen)
* to compare lesion detectability between wb-MRI and the gold standard positron emission tomography (PET)/CT
* to compare patient comfort between PET/CT and wb-MRI using a dedicated questionnaire
* to compare duration of image acquisition with regards to cost-effectiveness

Whole-body imaging becomes increasingly important in oncologic patients not only for primary cancer staging, but also for assessment of response to therapy. So far, PET/CT is a key method to assess cancer-related changes of metabolism in tumors, which is crucial for response evaluation and to differentiate between benign and malignant lesions. Limitations of PET/CT include the assessment of sclerotic bone metastasis, which often do not show increased tracer uptake. Certain organ metastasis (especially in brain and liver) are also barely detectable due to physiologically increased uptake. Moreover, both CT and administration of radioactive tracer are associated with radiation exposure for patients. Whole-body MRI (wb-MRI) including functional techniques (e.g. Diffusion-weighted Imaging (DWI) to evaluate cell density) enables a functional staging and therapy assessment without use of ionizing radiation. Advantages to assess sclerotic bone lesions and organ metastases have been confirmed in recent literature. Limitations of MRI include detection of lesions in organs with high susceptibility and motion like the thorax.

Eligibility Criteria:
Inclusion Criteria:

* Clinically indicated PET/CT for cancer staging or response assess-ment in patients with histopathologically confirmed solid tumors (e.g.prostate, breast, gastrointestinal, testicles)
* MRI can be scheduled within 1 week to PET/CT exam

Exclusion Criteria:

* general MRI contraindications (devices (e.g. certain pacemakers), pregnancy, claustrophobia)
* severely reduced general condition
* impaired renal function
Sprint to Fitness: Effect of Outcome Expectations on Responses to Interval Exercise Training

The purpose of this study is to research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.

The proposed research will investigate whether adding a treatment component that focuses on positive outcome expectations of a high-intensity interval training (HIIT) intervention produces greater improvements in psychological and physiological study outcomes. This project will yield empirical evidence that will inform how to help Americans meet physical activity guidelines; how to develop exercise programs that are more likely to promote exercise as a habit; and maintenance of health and a healthy body weight.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index of 25-35 kg/m2
* Sedentary (not regularly engaging in exercise more than once per week)
* Weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months)

Exclusion Criteria:

* Taking any medications that affect energy expenditure or treat high blood pressure
* Tobacco use
* Pregnant or breastfeeding or plan to become pregnant in the next 3 months
* Have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases)
* Resting systolic blood pressure ≥ 140 mmHg
* Resting diastolic blood pressure ≥ 90 mmHg
* Non-fasting plasma glucose of ≥ 200 mg/dl
Endostatin in Combination With Chemotherapy for Metastatic Nasopharyngeal Carcinoma

The investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (NPC).

To evaluate the progression free survival (PFS), overall survival (OS), Acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (NPC).

Eligibility Criteria:
Inclusion Criteria:

* metastatic nasopharyngeal carcinoma 6 months after first treatment,never receive any anticancer treatment except local radiotherapy to the bone metastasis，at least one measurable metastatic lesions，ECOG PS 0-1，Electrocardiogram (ecg) no special abnormal，comply with the test requirements, cooperate with regular follow-up.

Exclusion Criteria:

* To give local treatment,clinical severe infection(\>grade 2),with the central nervous system metastases,ECOG PS≥2,patients with pregnancy or breastfeeding,has a history of peripheral nerve disease,concomitant with other serious diseases,ever or concomitant with other serious diseases except for Cervical carcinoma in situ,cure of basal cell carcinoma,bladder surface tumor,any cancer 3 years after curation.
SNUH MICU Cohort Study of PICS

Prospective registry of patients admitted to the medical intensive care unit Patients discharged are followed up to 5 years after discharge


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the medical intensive care unit

Exclusion Criteria:

* Patients admitted to the intensive care unit for simple procedures
* Patients admitted for postoperative care observation