cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part I

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.

This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
* Delivery in the hospital

Exclusion Criteria:

* Infant admitted to the NICU
* Birth weight less than 1,400g
* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
Ablative Therapy in the Management of Prostate Cancer

The purpose of this study is collect observational data regarding patterns of care and outcomes of focal therapies for prostate cancer, including but not limited to: high-intensity focused ultrasound (HIFU), cryotherapy, focal laser ablation, irreversible electroporation, photodynamic therapy, and brachytherapy.

Through the use of a pro- and retrospective registry, the investigators will collect information on patient characteristics including age, co-morbidities, imaging and biopsy information, and prior treatments. Information on treatment details will also be captured, including treatment time, anesthesia delivered, and length of stay, when applicable. Oncologic outcomes including PSA, post-treatment biopsy and imaging data, need for re-treatment, and survival outcomes will also be captured. Safety outcomes will be captured using the Clavien-Dindo classification scale, and additional specific GU complications will be recorded, which include urinary retention, urethral stricture, recto-urethral fistula, osteomyelitis, and urinary tract infection. Finally, the investigators will capture functional outcomes using health related quality of life questionnaires including the EPIC questionnaire, IIEF-5, MSHQ-EjD, and IPSS.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Undergoing focal therapy for primary or salvage treatment of prostate cancer, or
* Have received prior focal therapy

Exclusion Criteria:

* Clinically-evident metastatic disease
* Unable to fill out an English-language questionnaire
68Ga-BNOTA-PRGD2 PET/CT in Patients With Rheumatoid Arthritis

This is an open-label positron emission tomography/computed tomography ( PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in rheumatoid arthritis (RA) patients. A single dose of nearly 111 MBq 68Ga-BNOTA-PRGD2 (≤ 40 µg BNOTA-PRGD2) will be intravenously injected into patients with RA. Visual and semiquantitative method will be used to assess the PET/CT images. Whole body 18F-FDG PET/CT will be performed for comparison.

The Alpha(v)beta3 integrin, one of the most prominent members of integrin superfamily, is trans-membrane heterodimeric proteins which mediate cell-cell and cell-extracellular matrix adhesion. Integrin alpha(v)beta3 receptor plays an pivotal role in promoting, sustaining and regulating the angiogenesis and was identified as a marker of angiogenic vascular tissue. Cyclic arginine-glycine-aspartic acid (RGD) peptides was identified as a key integrin recognition motif which could strongly bind to integrin alpha(v)beta3 and inhibit new blood vessel formation. Animal study in antigen induced arthritis demonstrated that intra-articular administration of a cyclic RGD antagonist of alpha(v)beta3 leading to inhibition of cell infiltrate, synovial angiogenesis, pannus formation, cartilage erosions and even diminishing arthritis severity. For these properties, RGD peptide-based multimodality molecular probes have been developed for noninvasive imaging by targeting integrin alpha(v)beta3. And compared with 18F-FDG PET/CT, radiolabeled RGD imaging is a promising approach to visualize angiogenesis and provide a therapeutic target for anti-angiogenetic and anti-integrin therapy.

For the further interests in clinical translation of 68Ga-BNOTA-PRGD2, an open-label PET/CT study was designed to investigate the diagnostic performance and evaluation efficacy of 68Ga-BNOTA-PRGD2 in RA patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilled the 1987 revised criteria of the American College of Rheumatology (ACR) for RA;
* Males and females, ≥18 years old

Exclusion Criteria:

* Concurrent medical conditions of other autoimmune diseases
* Latent or active joint infection or joint injury
* Renal dysfunction (serum level of creatinine more than 1.2 mg/dL)
* Females planning to bear a child recently or with childbearing potential
* Known severe allergy or hypersensitivity to intravenous radiographic contrast
* Inability to lie still for the entire imaging time because of cough, pain, etc
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance
Trichomonas Vaginalis Repeat Infections Among HIV Negative Women

The overall goal of this project is to determine the influence of patient treatment and host factors on repeat Trichomonas vaginalis (TV) infections among HIV-negative women

This study is a phase III randomized clinical trial. HIV-negative women who test positive for TV at their routine gynecological exam at participating clinics will be referred to the nurse/study coordinator to screen for eligibility, provide a description of the study, and obtain written, informed consent (N=700). Subjects will undergo an audio computer assisted self- interview (ACASI), and will self-collect vaginal swabs for Trichomonas testing by InPouch and Nucleic Acid Amplification Test (NAAT), Gram stain testing, and a future microbiome specimen. They will be randomized into one of two arms; metronidazole (MTZ) 2 g single dose (CDC recommended treatment regimen) or MTZ 500 mg twice daily x 7-day dose (CDC alternative treatment regimen). All enrolled women will be scheduled for a follow-up visit at four weeks post treatment completion (window 3-13 weeks).

Eligibility Criteria:
Inclusion Criteria:

* female
* English speaking
* \>= 18 years old

Exclusion Criteria:

* HIV-infected
* unable to provide informed consent
* pregnant
* breast feeding
* treated by their provider for Bacterial vaginosis (BV) at visit
Study to Determine the Impact of Multiple Doses of Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

An open label, 2-period, sequential study to determine the impact of multiple doses of ketoconazole on single-dose pharmacokinetics of HCV-796


Eligibility Criteria:
Inclusion Criteria:

- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Is There a Benefit of Postoperative ICU Management After Elective Surgery in Critical Ill Patients?

Postoperative care of high risk patients in the Intensive Care Unit (ICU) has for long been considered to be the gold standard of care in terms of reducing perioperative mortality.New evidence from a 7-day cohort study involving 27 countries comes to question this practice. The primary objective of our study is to detect any benefit of postoperative ICU care after elective surgery in terms of patient's outcome, length of hospital stay, complications and cost.

A prospective analysis of high perioperative risk patients that are about to be subjected into an elective operation will be included into the study. They will be allocated into two groups. Group ICU patients are those that are admitted into the ICU for postoperative care and those that are admitted into a standard ward consist Group Ward. Demographic data, the length of hospital stay, the outcome, the need of mechanical ventilation, the complications and the total cost will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients that will be scheduled for an elective operation and are considered to be in a high perioperative risk

Exclusion Criteria:

* Patients that are operated on an emergency basis
Abdominal Massage for People With Learning Disabilities and Constipation

Background and study aims:

Constipation, which is difficulty going to the toilet to do a 'poo' is common in adults with learning disabilities (LD), but there is not a lot of knowledge (information) about the best way to help treat constipation experienced by adults with learning disabilities. Adults with learning disabilities who have constipation should be assessed and treated. There is knowledge to suggest that abdominal massage may help some people with constipation so that people with constipation can go to the toilet more easily.

There is also knowledge to suggest that the use of a device to do the massage may be as beneficial as getting a carer to do it for the participant.

This research wants to invite 40 adults with learning disabilities with constipation to take part. 30 will be offered the abdominal massage, either by a carer or the device, and 10 will not be offered the massage. However, the participants will be shown how to do it at the end of the study.

This research wants to find out if people with LD are willing to take part in such a study and if the participants are more willing to let a carer do the massage, or would rather use the device. It is also important that the investigators know if the participants who are in the group not getting the massage are willing to continue in the research. Taking part for 6 weeks will provide the investigators with this important information before the investigators undertake a much larger study which the investigators need to do to find out if it helps with constipation.


Eligibility Criteria:
Inclusion Criteria:

1. A person with a Learning Disability who is known to suffer from constipation including:

1a-those on long term laxatives but still prone to constipation

1b- those who have been admitted to hospital due to impaction

1c- those who use enemas regularly but still have emptying problems.

Exclusion Criteria:

1. A history of malignant bowel obstructions or abdominal growth
2. A history of inflammatory bowel disease of the intestine e.g. Chron's disease
3. Unstable spinal surgery
4. Recent scarring or abdominal surgery
5. Abdominal skin lesions
6. Abdominal hernia
7. Pregnancy
8. Indwelling catheter
9. Increased sensitivity to touch
10. Has undertaken Abdominal Massage within the last 3 months.
Vitamin D Supplementation and Muscle Function in Older Adults

The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.

This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-\<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 to \<90 years
* SPPB \<=10
* Initial serum 25(OH)D concentration of 18 to \<30 ng/mL
* Not dependent on a walker
* Able to provide own transportation to study visits
* Not involved in another intervention study
* Willing to provide informed consent and adhere to the protocol

Exclusion Criteria:

* Serious or uncontrolled chronic disease including: insulin-dependent diabetes; cancer requiring treatment in past year, except non-melanoma skin cancers; acute coronary event (within the last 6 months), uncontrolled angina, heart failure (stage 3-4), PAD, or stroke (within the last 6 months); uncontrolled hypertension (BP\>200/110 mmHg); chronic respiratory disease requiring the use of oxygen; uncontrolled endocrine/metabolic disease; neurological (e.g., Parkinson's disease) or hematological disease; liver or renal dysfunction (eGFR \<45 mL/min/1.73m2); and musculoskeletal impairments severe enough to preclude functional testing
* Evidence of impaired cognitive function (MoCA \<18)
* Taking prescription vitamin D2 or taking \>1000 IU/day of vitamin D3 (from all sources); taking an oral corticosteroid (i.e., prednisone at 7.5mg/d for 3 mos or equivalent); taking hormone replacement therapy
* Inability or contraindications to consume daily vitamin D supplements (e.g., hypercalcemia, sarcoidosis, history of kidney stones in last 5 years)
* Knee or hip surgery within the last 6 months or planned knee or hip surgery within the next year
* Unwillingness to undergo a muscle biopsy or use of anti-coagulants
* Unintentional weight loss of ≥5% or more in the past 3 months
* BMI \>40 kg/m2
* If the PI feels the participant is unlikely to follow the protocol
Bougiecap for Treatment of Benign Stenosis in GI Tract

Feasibility testing of a cap-assisted endoscopic bougienage for benign upper GI stenosis with direct optical control.

Benign stenosis in the GI tract are endoscopically treated by using Savary-Gilliard Dilators. This method, although sufficient in its interventional success, provides only haptic control and often requires wire guidance or X-ray imaging for monitoring the position of the stenosis, the dilator and the dilation process.

To guarantee the missing optical feedback and enhance the intraprocedural control a conical, clear cap was developed. This single use device is attachable to the front end of an endoscope and provides direct visual evaluation of the mucosal damage and progress of the Bougienage, making x-ray imaging obsolete while resulting in an effective dilation. For the bougienage treatment, the endoscope with the cap on top is inserted into the patient's GI tract and aimed at the stenosis. By pushing the endoscope forward the cone shaped cap expands the mucosal diameter by conversion of longitudinal to radial force vectors. Lateral and frontal openings allow suction and flush during procedure.

The clear tapering cap is now to be tested for ist technical feasibility and ability to improve patients' quality of life following treatment. Therefore a quality of life questionnaire (Swal QoL) evaluating the patients' dysphagia is done right before and two weeks after the bougienage and an effective dilation is proved by being able to pass the stenosis with the endoscope after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* benign Stenosis of the esophagus
* indication for endoscopic treamtent of stenosis

Exclusion Criteria:

* no informed consent
* malignancy based Stenosis
* no indication for endoscopic treamtent
Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

This is a multiple-region, randomized, double-blind, placebo controlled, multiple-dose, study in participants with PNH who have clinically evident EVH on a C5 inhibitor (eculizumab or ravulizumab).

Participants will be randomized to receive danicopan or placebo, in a 2:1 ratio for 12 weeks (Treatment Period 1) in addition to their C5 inhibitor (eculizumab or ravulizumab) therapy. At Week 12, participants randomized to receive placebo will be switched to danicopan in addition to their C5 inhibitor for an additional 12 weeks (Treatment Period 2) and participants randomized to danicopan will continue on danicopan for an additional 12 weeks, while remaining on their ongoing C5 inhibitor therapy.

At the end of the 2 treatment periods (Week 24), participants may enter a Long-Term Extension (LTE) Period and continue to receive danicopan in addition to their C5 inhibitor therapy. The Long-Term Extension period will consist of a first year of LTE(Year1) and a second year of optional LTE(Year2).All patients will complete 72 weeks of LTE(Year 1) assessments. After Week 72 (at the end of the first year of LTE), patients have the choice to complete participation in this study or continue to the optional second year (Year2) of LTE.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PNH
* Clinically Evident EVH defined by:

  * Anemia (Hgb ≤9.5 gram/deciliter) with absolute reticulocyte count ≥120 x 10\^9/liter
* Receiving an approved C5 inhibitor for at least 6 months prior to Day 1
* Platelet count ≥30,000/microliters (µL)
* Absolute neutrophil counts ≥500/μL
* Documentation of/or willingness to receive vaccinations for N. meningiditis and prophylactic antibiotics as required

Exclusion Criteria:

* History of a major organ transplant or hematopoietic stem cell transplantation (HSCT)
* Participants with known aplastic anemia or other bone marrow failure that requires HSCT or other therapies including anti-thymocyte globulin and/or immunosuppressants
* Known or suspected complement deficiency
* Laboratory abnormalities at screening, including:

  * Alanine aminotransferase \>2 x ULN (\>3 x ULN in case of patients with documented liver iron overload defined by serum ferratin values

    * 500 ng/ML)
  * Direct bilirubin \>2 x ULN (unless due to EVH or documented Gilbert's Syndrome)
* Current evidence of biliary cholestasis
* Estimated glomerular filtration rate of \<30 milliliters/minute/1.73 meter squared and/or are on dialysis
* Evidence of human immunodeficiency virus, hepatitis B, or active hepatitis C infection at screening
Effect of VR on Pain and Patient Satisfaction in Adults Receiving GNRFA

The study team aims to investigate whether implementing virtual reality therapy (VRT) during Genicular nerve radiofrequency ablation (GNRFA) procedure will provide better alleviation of procedural pain and augmented satisfaction for patients.

Patients' experience through a medical procedure in a hospital environment is inherently stressful and painful. Although virtual reality (VR) was originally recognized for its entertainment value, it has recently been used as an innovative tool in clinical settings to reduce pain and anxiety, while improving patient satisfaction. VR is a computer generated simulation of a life-like experience that usually serves people for entertainment and social interactive purposes in a simulated three-dimensional environment. Virtual reality therapy (VRT) offers patients an opportunity to "get away" from noxious stimuli as they draw their attention towards another virtual world (Alem).

Virtual reality provides a cognitive distraction through creating a "real world illusion." VR may deter an individual's attention from pain as it offers a multimodal sensory distractor. This positive experience may result in reduction of pain score by decreasing the time patients think about their pain during a procedure.

Genicular nerve radiofrequency ablation (GNRFA) is an option to treat knee pain without surgery. The genicular nerves are the nerves that feed into the knee. Radiofrequency ablation is a process by applying radiofrequency waves to the nerves that are carrying the painful impulses from the knee joint. GNRFA uses fluoroscopy guidance to introduce 3 needles at each of the three genicular nerves which transmit sensation from the knee joint. This is followed by testing for sensory response, followed by administration of local anesthetic (2% lidocaine) per standard-of-care, and then radiofrequency ablation. This method of treatment is known to be very safe, convenient and reliable because fluoroscopy guidance provides high accuracy of localization at the procedure targets outside of the knee joint. Patients with symptomatic knee osteoarthritis have shown short and long term positive results following this method with significant reduction of pain levels (Kidd) and augmented functionality. This non-invasive procedure is able to successfully replace surgery or intra-articular therapy where the procedure is conducted directly on the knee joint.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Patients Undergoing a genicular nerve radiofrequency ablation
* Patients who have previously received nerve blocks or radiofrequency ablation procedures may be included

Exclusion Criteria:

* Requiring sedation during procedure
* Cognitive impairment or dementia
* History of recent stroke, epilepsy, psychosis, or claustrophobia
* Blindness or deafness
* Refusal to use the headset
* Isolation status for infection control
* Motion sickness or active nausea/vomit
* Pregnancy (Pregnancy testing point of care available for females of child bearing age)
Ion Irradiation of Sacrococcygeal Chordoma

The purpose of this study is to evaluate the safety and feasibility of primary hypofractionated irradiation of sacrococcygeal chordoma with carbon ions or protons using the raster scan technique.

The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococcygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection. The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity (CTCAE, version 4.0) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint. Local-progression free survival, overall survival and quality of life will be analyzed as secondary end points.

Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of sacrococcygeal chordoma
* Karnofsky performance status ≥ 70%
* Patients age 18 - 80 years
* Macroscopic tumour (MRI)
* Written informed consent

Exclusion Criteria:

* Lack of macroscopic tumour
* Tumor extension in craniocaudal direction \>16cm
* Metal implants at the level of the tumor which could influence the treatment planning
* Inability of the patient to lie quiet for at least 20 minutes (eg due to pain)
* Prior radiotherapy of the pelvic region
* Simultaneous participation in another trial that could influence the results of the study
* Active medical implants without treatment approval at the time of ion irradiation (eg, cardiac pacemaker, defibrillator)