cyrilzakka/clinical-trials huggingface dataset:
Dose-finding Study of BMS-955176 to Treat HIV-1 Infected Treatment-naive Adults

The purpose of this study is to find at least one dose of BMS-955176 that will be safe, effective and tolerable for HIV-1 infected treatment naive adults.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Men and non-pregnant women, at least 18 years of age
* Antiretroviral treatment-naïve; defined as no current or previous exposure to \> 1 week of an antiretroviral drug
* Plasma HIV-1 RNA ≥ 1000 copies/mL
* CD4 T-cell count \> 200 cells/mm3

Exclusion Criteria:

* Resistance or partial resistance to any study drug determined by tests at Screening
* Current or historical genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to EFV, TDF, FTC, Protease Inhibitors
* Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
* Blood tests that indicate normal liver function
* Hemoglobin \< 8.0 g/dL, platelets \< 50,000 cells/mm3
Comparative Results of Maxillary Deficiency Treatment by Fixed Tongue Appliance and Fixed Facemask in Growing Patients

A new fixed appliance will be used to transfer the tongue force during its physiological activity to advance the nasomaxillary complex; this method will be compared with the traditional method which uses a facemask with a fixed appliance in the mouth.

The above method will be compared with traditional one which uses the facemask in combination with an intra-oral fixed appliance.

Eligibility Criteria:
Inclusion Criteria:

* Growing patients
* Class III with maxillary deficiency

Exclusion Criteria:

* Previous orthodontic treatment
* Uncooperative patients
Hysterectomy With Adnexal Surgery Procedures With the DEXTER Robotic System (The HYPER Study)

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing robotic-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic hysterectomy with adnexal surgery for benign disease; using one camera port, two ports for the manipulating instruments, and additional ports as needed.

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision.
* Participation in another interventional clinical trial
Modified Environment for Agitation in Patients With TBI

This study examines the effect of an intervention consisting of dynamic circadian light and sound therapy, as well as systematic information on sleep pattern, agitated behavior and functioning level.


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate and severe Traumatic Brain Injury (TBI)
* Diagnosed with Glasgow Coma Score (GCS) lower than 13-

Exclusion Criteria:

* Patients with psychiatric diagnose and not speaking danish -
Selective Lung Recruitment in Moderate to Severe ARDS : a Pilot Study

Acute respiratory distress syndrome (ARDS) is an acute condition affecting the lung after clinical aggression ( infectious process, pancreatitis, acute inflammatory event). This condition lead to major breathlessness due to the incapacity to properly oxygenize the boby because of lung lesions. Invasive mechanical ventilation is frequently required to grant sufficient oxygenation to the body. Unfortunately, while it allows oxygenation, mechanical ventilation can cause arms to the lung because of the mechanical power it delivers to the lung and create ventilation induced lung injuries (VILI). To reduce this risk, ventilator settings have been protocolized aiming to reduce the lung volume administered to the lung. It is effective to control the VILI but oxygenation may be insufficient under those protective parameters. To correct this lack of oxygenation practicians use recruiting maneuvers when a transient increase of lung volume administered to the lung to open collapse parts of the lung. Those maneuvers can cause barotrauma and provoke pneumothorax or decrease the heart flow. This study aim to assess the feasibility of selective recruitment maneuvers to increase oxygenation while reducing the risk of recruitment maneuvers.

Briefly, a dedicated bronchial blocker is introduce in a lower part of the lung, a balloon attached to the catheter is expended isolating a part of the lung and a recruiting pressure is administered through the lumen of the catheter to selectively expend the isolated part of the lung.

After the selected recruitment maneuver, the investigators will assess the expansion of the lung with a CT-scanner.


Eligibility Criteria:
Inclusion Criteria:

* acute ARDS according Berlin definition and a PaO2/FiO2 ratio inferior to 200
* patient under sedation and muscular blockade
* postero-basal consolidation on CT or pulmonary ultrasound
* affiliated to the French social insurance system

Exclusion Criteria:

* hemodynamic instability
* pregnancy
* patient under guardianship
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)

This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants \<2 years of age with invasive fungal infection (IFI).

There are 2 panels in this study. In Panel A, POS IV will be evaluated in ≥8 participants. In Panel B, both POS IV and POS PFS will be evaluated in ≥14 participants, including ≥6 who are \<3 months of age and ≥5 who transition to the PFS formulation of POS.

Eligibility Criteria:
Inclusion Criteria:

* Panel A: is undergoing treatment for possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (which can include candidiasis)
* Panel B: has an investigator-assessed diagnosis of possible, probable, or proven IFI known or suspected to be cause by fungal pathogens against which POS has demonstrated activity (and cannot include candidiasis)
* Has a central line (eg, central venous catheter, peripherally-inserted central catheter) in place or planned to be in place before beginning IV study intervention.
* Has a body weight of ≥500 g
* The participant (or legally acceptable representative) has provided documented informed consent for the study.

Exclusion Criteria

* Has received POS within 30 days before Day 1
* Has cystic fibrosis, pulmonary sarcoidosis, aspergilloma, or allergic bronchopulmonary aspergillosis
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
* Has known or suspected active COVID-19 infection
* Has a known hypersensitivity or other serious adverse reaction to any azole antifungal therapy, or to any other ingredient of the study intervention used
* Has any known history of torsade de pointes, unstable cardiac arrhythmia or proarrhythmic conditions, a history of recent myocardial infarction, congenital or acquired QT interval (QT) prolongation, or cardiomyopathy in the context of cardiac failure within 90 days of first dose of study intervention
* Has received any listed prohibited medications within the specified timeframes before the start of study intervention
* Has a known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (Part B)
* Has suspected/proven invasive candidiasis (Part B)
* Has enrolled previously in the current study and been discontinued
* Has QTc prolongation at screening \>500 msec
* Has significant liver dysfunction
* Is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days
Impact of an Antioxidant Alimentary Complement on Sperm Data

Male infertility is a multifactorial disease process with a number of potential contributive causes. Considering the majority of male infertility cases are due to deficient sperm production of unknown origin, environmental and nutritional factors must be evaluated. The purpose of this study is to evaluate the effects of 6 months antioxidant dietary complement (Conceptio) on sperm parameters (sperm count, motility and DNA fragmentation) in infertile men with oligoasthenozoospermia.


Eligibility Criteria:
Inclusion Criteria:

* Number of sperm cells \< 15M / mL and\\or mobility \< 40 %.
* Signature of a form of not opposition to the research.
* Membership in a social security system.

Exclusion Criteria:

* Number of sperm cells = 100M / mL.
Study to Observe Safety and Efficacy of Nexavar in Treatment of Kidney Cancer

The objective of this Non-Interventional study is to evaluate the effectiveness \& safety of Nexavar in advanced Renal Cell Carcinoma (RCC) patients under daily-life treatment conditions based on age of the patient (older (age \>70 years) and younger patients (age \<70 years). Specifically investigated are the tumor status, duration of Nexavar ® treatment (number of cycles) and incidence of Hand foot Skin Reaction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of advanced Renal Cell Carcinoma (RCC) and decision taken by the investigator to prescribe Sorafenib

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information.
End-tidal Oxygen Can Reliably Predict the Arterial Partial Pressure of Oxygen Among Emergency Department Patients

Recent studies have shown that end tidal oxygen (ETO2) monitoring can be useful to determine the adequacy of preoxygenation. No study has assessed the correlation between ETO2 values obtained during preoxygenation to predict the PaO2 in patients undergoing RSI in the ED. Our objective was to determine whether a novel equation using the ETO2 at the end of preoxygenation could reliably estimate the partial pressure of arterial oxygen (PaO2) in critically-ill ED patients undergoing RSI.

Rapid Sequence Intubation (RSI) is the preferred and most commonly-used method of definitive airway management among critically ill emergency department (ED) patients requiring intubation. Adequate preoxygenation is intended to prolong the safe apnoeic period. Optimal preoxygenation for ED patient undergoing RSI is best described as a two-part process of denitrogenation of the functional residual capacity (FRC) and the formation of an oxygen reservoir within the alveoli. End-tidal O2 (EtO2) has been shown to be a reliable surrogate marker for denitrogenation. Most of the literature supporting EtO2 as an adequate maker of adequate preoxygenation has been conducted in the operating room setting. This population varies significantly from the population requiring endotracheal intubation in the ED. Our study aim was to show that the use of a gas analyzer measuring the fraction of inspired oxygen (FiO2) and EtO2 during the preoxygenation phase of ED RSI can reliably predict the minimal PaO2 at the end of the ED preoxygenation period.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing rapid sequence intubation.

Exclusion Criteria:

* Patients presenting to the emergency department in cardiac or traumatic arrest
* Patients who received bi-level positive airway pressure (BiPAP) as the primary delivery of preoxygenation.
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.

The investigators' hypotheses include the following:

1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older at time of consent, may be male or female.
* Able to provide a brief medical history and have/allow an examination of their skin including photographs.
* Capable of giving informed consent.
* Will be able to receive notification of follow-up recommendations

Exclusion Criteria:

* Patients who will not provide informed consent
* Patient who are unable to fulfill tasks of this study
Cook IVC Filter Study

This prospective, multicenter, double-arm clinical study further evaluated the safety and effectiveness of Cook's commercially available inferior vena cava (IVC) filters (specifically, the Günther Tulip® Vena Cava Filter and Cook Celect® Vena Cava Filters) in patients in need of temporary or permanent IVC filter placement for the prevention of pulmonary embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

* Requires temporary or permanent IVC filter placement for the prevention of PE

Exclusion Criteria:

* Less than 18 years of age
* Known hypersensitivity or contraindication to contrast medium that cannot be adequately premedicated
* Known allergy or sensitivity to cobalt, chromium, or nickel
* Pregnant or planning to become pregnant in the next 12 months
* Patient refuses blood transfusions
* At risk of septic embolism
* Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
* Existing IVC filter
* Duplicate IVC
* Anatomy that would prevent safe filter placement (e.g., condition of access vessels)
* IVC diameter \> 30 mm or \< 15 mm
Inspiratory Muscle Training and Neuromuscular Electrical Stimulation in Chronic Obstructive Pulmonary Disease

Chronic obstructive pulmonary disease (COPD) is a significant current public health problem, characterized by the presence of limited airflow. However, COPD has important manifestations beyond the lungs, the so-called systemic effects. These included dysfunction of peripheral and respiratory muscles. The growing amount of evidence has shown that patients with COPD also present important deficits in postural balance and consequently, increased risk of falling. As an essential part of the management of COPD, pulmonary rehabilitation (PR) alleviates dyspnea and fatigue, improves exercise tolerance and health-related quality of life, and reduces hospital admissions and mortality for COPD patients. Exercise is the key component of PR, which is composed of exercise assessment and training therapy. Currently, two modalities of therapy have been suggested as complementary to pulmonary rehabilitation: inspiratory muscular training (IMT) and neuromuscular electrical stimulation (NMES). Based on the premise that peripheral and respiratory muscle dysfunction can negatively impact postural control of patients with COPD, and given the importance of balance as a modifiable risk factor for falls, it is important to investigate whether the use of these therapeutic modalities (IMT and/or NMES) is capable of improving the short-term effects of pulmonary rehabilitation and also promoting improved balance.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD, in stages II, III and IV, according to criteria of the Global Initiative for COPD (GOLD);
* Clinically stable, i.e., absence of infections or exacerbations in the last 3 months;
* Medical team allows patient to exercise
* Availability of attending the rehabilitation program.

Exclusion Criteria:

* Unstable primary pathologies (cardiovascular, renal, metabolic, psychiatric);
* Hemodynamic instability;
* Nutritional supplementation on the 4 weeks preceding the study;
* Severe hearing or visual impairment recorded on patient chart or self-referred;
* Obesity (BMI \> 30 kg/m2);
* Neurological or musculoskeletal condition that severely limits mobility and postural control, thus making it impossible to carry out the assessments;
* Electronic devices, such as heart pacemakers and implantable cardioverter defibrillator;
* Skin injuries and infection where electrodes would be placed;
* Prior participation in pulmonary rehabilitation programs 3 months previous to the study;
* Vertigo;
* Active smoker and/or alcoholic;
* Neurological impairment or cerebellar lesions;
* Deficit in cognitive function;
* Severe vitamin D deficiency;
* Physically active.
A Study of Two Different Formulations of LY3209590 in Healthy Participants

The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
* Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
* Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for blood sampling
* Have given written informed consent approved by Lilly and the ethical review board governing the site

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Are women who are pregnant or lactating
* Have a history of multiple and/or severe allergic reactions
* Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
* Regularly use known drugs of abuse or with positive drug results
Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor

This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.

Primary Objective:

To describe the incidence and characteristics of, and change in, chronic neuropathy symptoms related to cisplatin, using the EORTC CIPN-20 instrument

Procedures:

The EORTC QLQ-CIPN20 questionnaire will be completed on day one of each cycle of chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from the last dose of chemotherapy. Patients will be asked to complete the questionnaire in clinic during their routine visits.

As part of this study, a DNA blood sample will be collected and stored with the Indiana Biobank on Day 1 of Cycle 1.

Eligibility Criteria:
Inclusion criteria:

1. 15 years of age or older at the time of informed consent
2. Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
3. Provide written informed consent and assent (if applicable).
4. Ability to complete questionnaire(s) in English by themselves or with assistance.
5. Willing to provide a 10 mL blood sample for future DNA testing
6. Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy.
7. Must agree to continued clinical follow-up at the study cancer center.

Exclusion criteria:

1. Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
2. Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
3. Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
Sedentary Behavior in African Americans

The study is designed to develop methods for objectively measuring sedentary behavior, assess the association between objectively measured sedentary behavior and cardiovascular disease outcomes, and develop an intervention to reduce sedentary behavior, in African American adults.


Eligibility Criteria:
Inclusion Criteria:

* self-classify yourself as African American
* are aged 18 years or older
* are free of serious medical condition, such as cancer, cardiovascular disease, or emphysema.
* are free of serious medical conditions that would prevent participant from engaging in physical activity.
* are willing to have a scan completed that measures your body composition
* are willing to stay in metabolic chamber for 8.5 hours (8:00am until 4:30 pm)
* are willing to wear an accelerometer for 2, one-week periods following your chamber stay. There will be one week in-between the 2, one-week periods.
* are willing to complete questionnaire related to your level of activity
* weigh less than 250 lbs.

Exclusion Criteria:

* unwilling or unable to perform activities in protocol
* on medications
* a woman who is intending to become pregnant, or who is pregnant
Comparison of the Efficacy of Sacral Espb and Caudal Block for Pain Management After Urogenital Surgeries in Children

The aim of this study was to compare the efficacy of caudal block and sacral espb used as a postoperative analgesia method in urogenital pediatric surgery cases.

The parents of the patients who will undergo urogenital surgery will be included in the study after being informed and written consent is obtained. They will be randomised and divided into two groups. After general anaesthesia, sacral espb will be performed in the 1st group and caudal block will be performed in the 2nd group and postoperative pain will be evaluated with Face, Leg, Activity, Cry, Consolability (FLACC) score.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1-7 years undergoing paediatric urogenital surgery
* Patients in American Society of Anesthesiologist (ASA) class I-II

Exclusion Criteria:

* Patients whose parents do not give consent
* Patients with anatomical changes in the sacral region, previous surgery, scar and infection,
* Patients with known local anaesthetic allergy
* Patients for whom regional anaesthesia is contraindicated
* Known neurological or muscular disease