cyrilzakka/clinical-trials huggingface dataset:
VISIBILITY™ Iliac Study

The VISIBILITY Iliac study is a prospective, multi-center, non-randomized study confirming the safety and effectiveness of stenting using the Visi-Pro™ Balloon Expandable Stent System for the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient has claudication as defined by a Rutherford Clinical Category Score of 2, 3 or 4.
* Evidence of ≥ 50% stenosis, restenosis or occlusion of target lesion(s) located in the common iliac artery and/or external iliac artery.
* Willing to comply with all follow-up evaluations at the specified times.
* Provides written informed consent prior to enrollment in the study.

Exclusion Criteria:

* Previous implantation of stent(s) in the target vessel.
* Received endovascular treatment of the target lesion within six months prior to the index procedure.
* Known hypersensitivity to contrast material that cannot be adequately pretreated.
* Known hypersensitivity to 316L stainless Steel.
* Life expectancy of less than 12 months
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Subjects

To assess the safety and tolerability of ascending single oral doses of SAM-531 in healthy subjects.To obtain preliminary pharmacokinetic (PK) and pharmacodynamic (PD) profiles of SAM-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the PK of SAM-531 administered to healthy subjects.


Eligibility Criteria:
Inclusion criteria

1. Men or women of nonchildbearing potential aged 18 to 45 years
2. Elderly men or women aged 65 years and above as of study day 1.
3. Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.

Exclusion criteria

1. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease
2. Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
3. Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.
Does a High BMI Affect Supervised Pelvic Floor Muscle Training for Improving Symptoms in Women With Various Stages of Pelvic Organ Prolapse?

The trial design is a quasi-experimental cohort trial that includes women referred for pelvic organ prolapse specific physiotherapy.

Candidates will be selected via a convenience sampling method from four physiotherapy outpatient departments at a NHS trust within Greater Manchester. The data collection occurred in January-June 2019 and ethical approval was granted by School Research Ethics, University of Salford.

Treatment aims to ensure there is respect for their autonomy, treatment is fair (Justice), no harm is done to the participant (nonmaleficence) and treatment benefits the participants (beneficence).

Participants are required to complete a consent form prior to their initial session. To ensure methodological quality, the STROBE guidelines will be followed to make certain all apt information required is reported to allow for replication of the intervention.

The trial aims to include (n=60) women with a diagnosed pelvic organ prolapse. They are required to complete 16 weeks of supervised pelvic floor exercises with a specialist physiotherapist as documented within the most recent NICE guidelines.

The outcome measures used will be the Pelvic Organ Prolapse symptom score (POPSS) and this will be documented before and after the 16 week period.

Along side the POPSS, the patients body mass index and severity of pelvic organ prolapse will also be recorded and the results of this will be correlated post trial using the relevant data analysis testing methods.


Eligibility Criteria:
Inclusion Criteria:

* Gynaecologist diagnosed women with a mild / moderate or severe pelvic organ prolapse
* \>18 years old

Exclusion Criteria:

* Unwilling or unable to provide informed consent (opt out of treatment)
* Unable to contract the pelvic floor muscles (determined by the treating physiotherapist)
* History of Pelvic cancer / or radiotherapy treatment within three months,
* Neurological or psychiatric disorders,
* Untreated urinary tract infections,
* Pregnant or planning to become pregnant or given birth within the past year,
* Recent vaginal surgery within twelve weeks or evidence of genital oedema,
* Suspected infection or fragility of the genital area As indicated by the referral source or patient reported at the initial assessment.
Fronto-parietal tDCS in Severely Brain Injured Patients With Disorders of Consciousness

Previous studies showed that anodal transcranial direct current stimulation (tDCS) transiently improves performance of memory and attention. In severely brain injured patients with disorders of consciousness (DOC), a single stimulation over the left dorsolateral prefrontal cortex has shown to improve patients' sign of consciousness. Nevertheless, other brain areas could be stimulated in order to increase the number of responders. In this study, investigators will assess the effects of bilateral fronto-parietal tDCS on Coma Recovery Scale-Revised (CRS-R) scores in patients with DOC in a double-blind sham-controlled experimental design.

Following severe brain damage and coma, some patients may remain in a vegetative state (VS) or minimally conscious state (MCS). At present, there are no evidence-based guidelines regarding the treatment of patients with disorders of consciousness (DOC). A previous study showed that a single stimulation (using transcranial direct current stimulation - tDCS) of the left prefrontal cortex induces an behavioral improvement in some patients in DOC. Nevertheless, only 43% of patients in MCS responded to the stimulation. Therefore, it is needed to find new protocols to increase the number of responders and improve the effect of tDCS in patients with DOC.

In this study, investigators aim to assess the effect of single session anodal (i.e., excitatory) transcranial direct current stimulation (tDCS) over right and left fronto-temporal cortices (using 4 anodes and 4 cathodes), on the level of consciousness of patients with DOC, in a double blind randomized sham controlled study. The anodes will be placed over F3, F3, CP5 and CP6.

tDCS is a form of safe non-invasive cortical stimulation, modulating cortical excitability under the electrodes, via weak polarizing currents. It has been reported that anodal tDCS transiently improves working memory and attention by stimulating the left DLPF in healthy subjects and patients with stroke, Parkinson's or Alzheimer's disease. By increasing the surface of the stimulated area, it is expected to increase the number of responders as patients' brain lesion are very heterogeneous and widespread.

Eligibility Criteria:
Inclusion Criteria:

* post comatose patients
* patients in minimally conscious state
* patients with stable condition
* patients free of sedative drugs and Na+ or Ca++ blockers (e.g., carbamazepine) or NMDA receptor antagonist (e.g., dextromethorphan)

Exclusion Criteria:

* premorbid neurology antecedent
* patients in coma
* patients \< 28 days after the acute brain injury
* patients with a metallic cerebral implant
* cranioplasty
* shunt
Optimal Treatment of Miscarriage

The main objective of the study is to determine if there is a difference in the number of women with a complete miscarriage after 10 days between expectant management versus treatment with 800 micrograms of misoprostol intravaginally in women with an an incomplete miscarriage before 14 weeks and a gestational sac retained in the uterus.


Eligibility Criteria:
Inclusion Criteria:

* nonviable intrauterine pregnancy with retained gestational sac in the uterus
* the embryo if visible 5 to 35 mm without a heart beat
* vaginal bleeding
* circulatory stable
* hemoglobin at least 80 g/L

Exclusion Criteria:

* contraindications against misoprostol
Investigate a Pharmacokinetic Characteristics and the Safety of AG1502 in Healthy Male Subjects

Primary object : Evaluate pharmacokinetic property AG1502 and Candesartan 32mg and Atorvastatin 40mg in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy males 19 to 45 years at screening.
* BMI 18-29 kg/m2

Exclusion Criteria:

* History of cardiovascular, respiratory, hepatic, renal, neuropsychiatric, endocrine, hematologic disease
* Hypersensitivity reactions to drugs or significant hypersensitivity reactions in the history of Candesartan and Atorvastatin
* Hypotension (DBP ≤ 100 mmHg or SBP ≤ 95mmHg) and hypertension (SBP ≥ 150 mmHg or DBP ≥ 95 mmHg)
* Gastrointestinal disease affected the absorption of medications
* Genetic disease of Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
* AST or ALT \> 2 x normal range
* Total bilirubin \> 2.0 mg/dl
* CK \> 2 x normal range
* eGFR \< 60 mL/min/1.73m2
* Subject who have drunken habitually (alcohol more than 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or who are unable to quit drinking during this study
* Subject who have smoke habitually more than 10 cigarettes/day or who are unable to quit smoking during this study
* Subject who treated with any investigational drugs within 90 days before the administration of investigational drug
* Previously donate whole blood within 60 days or component blood within 30 days or transfusion within 30 days
* Subject who treated with any drug within 30 days can affect absorption, distribution, metabolism, excretion of candesartan or atorvastatin
* Subject who treated with any Rx only drug or herbal drug within 14 days and any OTC within 7 days
* History of drug abuse
* Genetic neuromuscular disorder or family history of neuromuscular disorder
* Unusual diet affected the absorption, distribution, metabolism, excretion of medications
* Subjects deemed ineligible by investigator based on other reasons
Anemia Etiology Evaluation in Ethiopia

The AnemEE study is a population-based anemia etiology survey in six regions of Ethiopia. The primary aim of the study is to evaluate the relative contribution of risk factors for anemia among children, women of reproductive age, and adult men. The study data are intended to inform evidence-based decision-making on anemia control interventions.

The AnemEE study is a population-based cross-sectional survey of children (6-59 months), adult women of reproductive age (15-49 years) and adult males (15-49 years) in six regions of Ethiopia (Afar, Amhara, Tigray, Oromia, Southern Nations, Nationalities and Peoples' Region and Addis Ababa). The study will enroll approximately 5,100 participants and will be conducted in two survey rounds; one survey round in the Belg season and one survey round in the Meher season. All participants will have hemoglobin assessed and will have standardized questionnaires administered to assess sociodemographic, diet, morbidity, and other health/nutrition factors. All participants will also have assessments of anthropometric measures, malaria, and soil transmitted helminth infection. A subset of participants will also have serum ferritin, CRP, AGP, vitamin B12, and folate concentrations assessed. The study data will be used to determine the relative contributions of risk factors for anemia.

Eligibility Criteria:
Inclusion Criteria:

1. Women of reproductive age

   * Female living in a selected household that has a woman 15-49 years of age
   * Aged 15-49 years
2. Adult Men

   * Male living in a selected household that has a woman 15-49 years of age
   * Aged 15-49 years
3. Children

   * Male or female child living in a selected household that has a woman 15-49 years of age
   * Aged 6-59 months

Exclusion Criteria:

* Does not provide informed consent
Treatment Of Fever In The Emergency Department

Fever is a frequent cause of admission to the Emergency Department (ED) around the world. While it can be caused by a wide range of conditions, the most effective treatment based on its etiology is still undetermined. This observational, prospective, single-center study enrolled adult patients who accessed the ED for fever, with the aim to define the most effective treatment for them.

Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and 1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS after two hours (T2). Adverse events, the needing of a rescue therapy and the response based on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* fever with/without associated symptoms
* adults who had given their consent to participate in the study.

Exclusion Criteria:

* age \< 18 years old
* contraindications or allergies to Paracetamol, Ibuprofen or to the combination Paracetamol/Ibuprofen
* patients unable to take oral drugs
* patients who did not express their consent to participate to the study
RE104 Clinical Lactation Study

The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.


Eligibility Criteria:
Inclusion Criteria:

* Females between 18 and 45 years of age, at elast 50 kgs, and a body mass index of 18-34 kg/m2
* Has had a normal term pregnancy and has been breastfeeding or activley pumping for at least 4 weeks pospartum
* Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
* Willing and able to pump in order to maintain sufficient milk supply volumes for the study
* Is not pregnant or planning to become pregnant during the study
* Able to understand and adhere to study schedule and requirements and willing to sign an ICF
* In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening

Exclusion Criteria:

* Has mastitis or other condition that would prevent the collection of milk from one or both breasts
* Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder
* Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
* Has used or intends to use of prohibited medications
* Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
Acute Effects of Supplemental Oxygen on Memory Testing in Healthy Adult Volunteers

Forty healthy adults (i.e., not recruited with respect to any particular diagnosis) are each alternately provided with supplemental oxygen and air via nasal cannula at about 6 Liters per Minute (LPM), while completing memory tests.

Prior studies have reported that supplemental oxygen can confer acute benefits to cognition. Here, the investigators seek to replicate/extend such findings by assessing whether such benefits can be seen using an Inogen oxygen concentrator with subjects with an average age around 65 years old. The investigators include a standard measure of cognition previously reported to be sensitive to supplemental oxygen (2-back test) and a novel, in-development adaptation of a memory test for medical-related content (Medical icons spatial test).

Eligibility Criteria:
Inclusion Criteria:

Subjects are intended to represent "healthy adults." Patients will include a mix of self-reported gender and ethnic/racial identification.

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Adult (aged 22+)

Exclusion Criteria:

* Patients who self-report diagnosis of respiratory-related conditions will be excluded.
* Subjects with a known polyvinyl chloride (PVC) allergy will be excluded, due to potential use of a standard, PVC-based cannula in the study.
Role of Hysterectomy in the Treatment of Borderline Ovarian Tumors

Borderline ovarian tumors (BOT), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion.

Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral adnexectomy. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.

Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

Borderline ovarian tumors (BOTs), are rare epithelial ovarian tumors characterized by the presence of frankly malignant cytologic features in the absence of stromal invasion. Serous BOTs, which account for 67% of all BOTs, are limited to one ovary in 75% of cases and are frequently accompanied by predominantly noninvasive peritoneal implants. In 30% of cases, BOTs are mucinous, unilateral, and characterized by a low rate of extra-ovarian spread and invasive implants. Patients with BOT are diagnosed at FIGO stage I in 78.9% of cases, are usually young, and have a favorable prognosis with 5-year survival affecting more than 80% of patients.

Surgical treatment of perimenopausal and postmenopausal BOT requires bilateral annissiectomy. Otherwise, the role of hysterectomy in perimenopausal and postmenopausal women with early-stage BOT remains unclear. Although some studies have reported an increased recurrence rate in the group of patients treated with uterine preservation, these data are severely limited by the small sample of patients and the presence of confounding factors in the analysis of oncologic outcomes.

Determining the impact of hysterectomy on the survival outcomes of perimenopausal and postmenopausal patients diagnosed with early FIGO stage BOT is necessary to avoid overtreatment, hysterectomy being associated with a low but not negligible rate of morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Women in menopause clinically defined as absence of menstrual cycle for 12 months
* Primary diagnosis of BOT confirmed by pathological examination
* Surgical treatment of BOT by BSO with (group 1) and without (group 2) hysterectomy
* Informed consent acquisition

Exclusion Criteria:

* Occurrence of BOT at index intervention
* Stage IV
* Metastatic disease
* Patients with previous hysterectomy
* Cancer synchronous of the endometrium
* Patients who have not had follow-up before 5 years (excluding those who have not reached the 5 year follow-up for the following events: death from any cause, death from BOT, recurrence of BOT)
The Clinical Utility of Extracorporeal Shock Wave Therapy on Hand Burns

No study has investigated the effect of extracorporeal shock wave therapy (ESWT) on hand function and hypertrophic scar characteristics. To investigate ESWT effects on burned hands, the investigators compare the results of ESWT combined with manual therapy group to the results of matched conventional(CON) rehabilitation combined with manual therapy group.

Hands are the most frequent injury sites caused by burn, and appropriate rehabilitation is essential to ensure that good functional recovery is achieved. In burn patients, the wound healing process may lead to a fibrotic hypertrophic scar, which is raised, red, inflexible and responsible functional and cosmetic impairments.

This randomized, controlled trial involved 40 patients with burns and dominant right-hand function impairment. Patients were randomized into a ESWT or a CON group. Each intervention was applied to the affected hand for 4 weeks once per week. Hand function was evaluated using the Jebsen-Taylor hand function test (JTT), grasp and pinch power test, and Michigan Hand Outcomes Questionnaire (MHQ). These assessments were evaluated pre-intervention and 4 weeks post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* a deep partial-thickness (second-degree) burn or a full thickness (third-degree) burn to their hands
* less than 6 months since the onset of the burn injury

Exclusion Criteria:

* fourth-degree burns(involving muscles, tendons, and bone injuries)\\
* musculoskeletal diseases(fracture, amputation, rheumatoid arthritis, and degenerative joint diseases) in the burned hands
* neurological diseases(such as peripheral nerve disorders)
* preexisting physical and psychologic disability (severe aphasia and cognitive impairment that could influence the intervention)
* severe pain impeding hand rehabilitation
Developing a Trauma-focused Intervention for Older Adults Living With HIV

Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.


Eligibility Criteria:
Inclusion Criteria:

* Living with HIV
* 50 years old or older
* \<100 % ART adherence
* depressive symptoms

Exclusion Criteria:

* Not living with HIV
* \<50 years
* 100% ART Adherence
Efficacy of Ketorolac 0.4% in Prostaglandin Suppression

A pilot study to evaluate the extent of PGE2 inhibition (mean aqueous values) by Ketorolac 0.04% following peripheral iridotomy


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo phakic IOL implantation

Exclusion Criteria:

* History of intraocular surgery in the operative eye
Effects of Feeding Schedule on the Development of ICU Delirium

This study will investigate if enteric feeding schedules alter the development of delirium in Intensive Care Unit patients who have been placed on mechanical ventilation. Delirium is an altered state of consciousness, which can involve agitation, inattention, and decreased awareness. We will enroll Intensive Care Unit patients who have been placed on a ventilator and are being given tube feedings. We will randomize participants into two groups: one group will receive continuous feedings via feeding tube, and the other group will receive feedings on a schedule to mimic breakfast, lunch, a snack, and dinner. Subjects will be assessed for the development of delirium. Subjects will also be monitored for sleep quality.

Patients will need to have at least 48 hours of enteric feedings to be included, and will be stratified by their APACHE IV score. Patients will be randomized into time restricted feeding vs continuous feeding by investigators, with no change in caloric intake nor nutrient content from orders. Patients will be assessed for delirium using the CAM-ICU (Confusion Assessment Method in the Intensive Care Unit) screening tool every twelve hours. At the time of the CAM ICU assessment, as part of the experimental design, the patient's sleep will be monitored by X8 Sleep Profiler device, placed and secured to their forehead, and the Sleep Profiler device will collect information regarding sleep quality as assessed by relative delta power, relative theta power and relative beta power.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the ICU
* Mechanically ventilated
* Receiving enteric feedings for at least 48 hours

Exclusion Criteria:

* Pregnancy
* Previously diagnosed neurocognitive disorders,
* Alcohol withdrawal and history of alcohol dependence