cyrilzakka/clinical-trials huggingface dataset:
A Virtual Reality Study of Cognitive Biases in Body Dysmorphic Disorder

Previous research shows that individuals with Body Dysmorphic Disorder (BDD) misinterpret ambiguous social information in a negative and threatening manner. These erroneous threat appraisals are thought to maintain disorder symptomatology and psychosocial impairment by reinforcing individuals' distorted self-image and ideas of social undesirability. Thus, maladaptive interpretation biases represent an important treatment target for this population; however, existing bias assessments and modification protocols are limited by the hypothetical and distal nature of scenarios and do not capture momentary experiential threat processes. The proposed study seeks to test virtual reality (VR) technology as a novel, in vivo means of eliciting, identifying, and measuring threat interpretation biases in a clinical sample to better understand the fear/threat structure activated during social interactions in BDD. Findings have the potential to enhance our understanding of disorder maintenance and identify more nuanced treatment targets. This study represents a critical first step in the long-term goal of harnessing VR gaming technology to supercharge existing treatment approaches for this debilitating illness.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+,
* Fluent in English,
* Meet DSM-5 criteria for principal BDD (BDD group) or no other current psychiatric diagnosis (HC group; assessed via clinical interview).

Exclusion Criteria:

* Lifetime psychosis; current bipolar disorder in acute or hypomanic episode; current severe substance use disorder; acute, active suicidal ideation
* Intellectual disability or cognitive impairment that would interfere with participation
the Impact of Covid-19 Pandemic Stress on Pregnancy Outcomes

This study is aiming to evaluate the effects of the COVID-19 pandemic stress on pregnancy outcomes including the sex ratio at birth.

* Coronavirus disease 2019 (COVID-19) is an emerging respiratory disease caused by a single-strand, positive-sense ribonucleic acid (RNA) virus, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) virus (Masters, 2019).
* The sex ratio (ratio of boys to girls) at birth (SRB) is about 1.01-1.05 in most populations (Abdoli, 2020). Various influencing factors affect the SRB, including maternal stress, endocrine disruption, maternal inflammatory responses and maternal nutrition (Lipner et al., 2019).
* These stressful life events consequently influence on maternal immunological and endocrine conditions, and the male fetuses are more vulnerable to be affected by these conditions. It is of interest that male fetus is biologically weaker and more susceptible to prenatal events and diseases than female fetuses. Hence, premature death is higher in boys than girls (Ahrenfeldt et al., 2017).
* The recent pandemic of the coronavirus disease 2019 (COVID-19) has been known to have various impacts on pregnant women (Rasmussen et al., 2020). Placentas of infected mothers show inflammatory, vascular and thrombotic changes (Prochaska et al., 2020). Among the neonates, children and adults (Bjelosevic et al., 2017), higher morbidity and mortality of males than females were reported. It is observed that the incidence of stillbirth was significantly increased during the pandemic period than during the pre pandemic period in London, UK (Khalilet al., 2020).
* The start of appearance of Covid 19 cases in Egypt was in March 2020, with subsequent increase in cases with its peak in May, June and July 2020, with lockdown and social and financial affection with great stress on families

Eligibility Criteria:
Inclusion Criteria:

- 1. All pregnant women attended to the Women health hospital in a period from January 1st 2019 to December 31st 2019 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies.

2. All pregnant women attended to the Women health hospital in a period from May 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management.

Exclusion Criteria:

* 3. Pregnant women attended to the Women health hospital in a period from April 1st 2020 to December 31st 2021 for child birth or miscarriage (either first or second trimesters) or ectopic or molar pregnancies management who conceived before April 1st 2020
Learning Curve of Optiscope by Anesthesia Providers

Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope for endotracheal intubation. This study will investigate learning curve of Optiscope by anesthesia providers.


Eligibility Criteria:
Inclusion Criteria:

* Patient who is scheduled general anesthesia for elective surgery

Exclusion Criteria:

* patient who is anticipated difficult airway
* patient who is needed rapid sequence induction
* Cervical injury
Safety Study of Outdoor and Indoor Mobility in People With Spinal Cord Injury (ROBOtics Spinal Cord Injury EKSO).

The aim of this study will be to evaluate the safety and the efficacy of a new robotic exoskeleton device in subjects with Spinal Cord Injury (SCI) and in subjects with other neurological disease with an impairment of lower limbs.

In this study, 30 participants with chronic spinal cord injury will undergo a 8-week training schedule for ambulation with the EKSO™ device.

Ekso™ is a wearable bionic suit which enables individuals with any amount of lower extremity weakness to stand up and walk over ground with a natural, full weight bearing, reciprocal gait. Walking is achieved by the user's weight shifts to activate sensors in the device which initiate steps. Battery-powered motors drive the legs, replacing deficient neuromuscular function.

Ekso provides functional based rehabilitation, over ground gait training, and upright, weight bearing exercise unlike any other. It has been designed for the needs of busy therapists treating a wide range of patients in a single day. The suit is strapped over the users´ clothing with easy adjustments to transition between patients in as little as five minutes.

Before, during and after training sessions the subjects will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton.

Eligibility Criteria:
Inclusion Criteria:

* Chronic motor complete or incomplete cervical and thoracic (C7-T12) spinal cord injury.
* Skin integrity.
* Adequate hip, knee and ankle range of motion.
* Spasticity level of 3 or less (Ashworth scale).

Exclusion Criteria:

* Cardiological or respiratory comorbidity.
* Hemodynamic instability.
* Presence of unhealed fractures.
* Presence of heterotopic ossification that may impede walking.
* Presence of osteoporosis.
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male or female subjects, at least 18 year of age.
* Complicated intra-abdominal infection is present at most under two weeks duration.
* Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.

Exclusion Criteria:

* Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
* Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
* Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.
Carotenoid Response to the Intake of Vegetables and Fruits

The purpose of this study is to validate the non-invasive tool, resonance Raman spectroscopy for assessing vegetable and fruit consumption.

This study will validate the use of resonance Raman spectroscopy to assess vegetable and fruit intake by performing a controlled feeding study during which volunteers will consume a provided diet with known amounts of carotenoids in the form of fruits and vegetables.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 - 65 years
* Weight stable (±5 lbs) for at least 2 months prior to the start of the study
* Body mass index (BMI) between 19-30 kg/m2
* Willing to refrain from the use of nicotine and dietary supplements for the duration of the study
* Willing to maintain baseline weight and physical activity levels

Exclusion Criteria:

1. BMI greater than 30.
2. Gastrointestinal disorders, disease, or medication that affects carotenoid absorption or storage
3. Current smoker
4. Allergies or intolerances to foods to be utilized in the study
5. Consumption of greater than an average of 1 alcoholic drink/day for women and 2/day for men, use of nutritional/sports supplements (if unwilling to discontinue during the study)
6. Pregnancy or lactating
Ranibizumab and Reduced Fluence PDT for AMD

Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.

Eligibility Criteria:
Inclusion Criteria:

1. Willingness to sign informed consent.
2. Age greater than 50.
3. Evidence of macular degeneration in the form of drusen in either eye.
4. Visual acuity of 20/25 to 20/800.
5. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:

   1. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
   2. Documented enlargement of lesion on FA
   3. Increase of 50 microns or more in the central subfield on OCT
   4. New blood
6. Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria:

1. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
2. Previous treatment of the enrolled eye for CNV
3. Intraocular surgery within 6 weeks of enrollment
4. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
5. Known hypersensitivity to verteporfin
6. Medical condition that would preclude regular follow-up for one year.
7. Previous vitrectomy
8. Media opacities limiting visual acuity, retinal examination, or retinal imaging.
9. A lesion where \> 50% of the lesion is a pigment epithelial detachment. -
Study Of AG-013736 In Patients With Refractory Metastatic Renal Cell Cancer

To determine the activity and response rate of AG-013736 in patients with advanced and refractory renal cell cancer, (patients who also failed on sorafenib-based therapy).


Eligibility Criteria:
Inclusion Criteria:

* RCC with metastases and nephrectomy
* failure of prior sorafenib-based therapy
* at least 1 target lesion that has not been irradiated
* adequate bone marrow, hepatic and renal function, \> or equal to 18 years of age.

Exclusion Criteria:

* Gastrointestinal abnormalities
* current use or inability to avoid chronic antacid therapy
* current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2 inducers
* active seizure disorder or evidence of brain metastases.
Study on Anal Human Papillomavirus Infection and Anal Intraepithelial Neoplasia Among Men Who Have Sex With Men in Indonesia, Malaysia, and Thailand

OBJECTIVES

1. To determine the prevalence and incidence of anal HPV infection, including infection with high-risk HPV types, among MSM in Indonesia, Malaysia, and Thailand.
2. To study the prevalence and incidence of HGAIN among these MSM.
3. To evaluate risk factors, including HIV status, for anal high-risk HPV infection and HGAIN among these MSM.

Study population An approximately 75 HIV-positive and 75 HIV-negative MSM who attended the study clinic in Kuala Lumpur, Jakarta, and Bangkok will be enrolled. The study will also enroll 185 HIV-positive and 95 HIV-negative MSM who are previous participants of the MSM VCT study. There will be approximately 260 HIV-positive and 170 HIV-negative MSM in total in this study.

This is a prospective cohort study that will newly enroll approximately 150 MSM in Kuala Lumpur, Jakarta, and Bangkok and follow them prospectively with a group of 280 MSM who are previous participants of a study entitled "Multidisciplinary services to enhance HIV testing and linkage to care among MSM" (MSM VCT study) in Jakarta, Bali, and Bangkok. Newly enrolled MSM will have three study visits at baseline, month 6, and at month 12. MSM who are previous participants of the MSM VCT study will only have one study visit.

Eligibility Criteria:
Inclusion Criteria:

1. Male with history of anal sex with men or previous participants of the MSM VCT study.
2. Age 18 years old or older.
3. Indonesian or Malaysian or Thai citizen as identified by the Indonesian or Malaysian or Thai National Identification card.
4. Willing to provide location or contact information and allow contact.
5. Available for follow-up for the planned study duration.
6. Understand the study and sign informed consent form.

Exclusion Criteria:

1. History of prior treatment for anal cancer OR had anal cytology or high-resolution anoscopy or infrared coagulation within 12 months prior to enrollment OR had trichloroacetic acid or podophyllin application of the intraanal area in the past month OR evidence of active concurrent intraanal or perianal bacterial or herpes simplex infection.
2. Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with ability to give informed consent.
Pycnogenol and Endothelial Function in Coronary Artery Disease

Pycnogenol® is a proprietary bark extract of the French maritime pine tree (Pinus pinaster ssp. atlantica). Pycnogenol® has prevented pathologic symptoms such as chronic inflammation and increased platelet aggregation, a risk factor for cardiovascular diseases. The endothelium is increasingly recognized not only a target (with vascular remodelling occurring in response to an injury and resulting in atherosclerosis), but also a mediator in the pathogenesis of atherosclerosis. Indeed, endothelial cells play an important regulatory role in the cardiovascular system by the expression of numerous molecules and release of mediators such as nitric oxide (NO), superoxide and endothelin-1 (ET-1). Data from animal studies, as well as human studies indicate that Pycnogenol may improve endothelial function, which is a powerful surrogate for clinical prognosis.


Eligibility Criteria:
Inclusion Criteria:

* History of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test)
* Stable cardiovascular medication for at least 1 month
* Age ≥ 18 years of age at time of signing the informed consent
* Informed consent for participation in the study

Exclusion Criteria:

* Myocardial infarction, unstable angina, stroke (within 3 months before randomization)
* Thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization)
* Uncontrolled symptomatic congestive heart failure (NHYA\> II) in the last 4 weeks prior to study
* Renal insufficiency (Creatinine Clearance \< 50ml/min)
* Ventricular tachyarrhythmias
* Poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmHg
* Symptomatic hypotension
* Obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism and adrenal insufficiency
* Severe uncorrected valvular disease or left ventricular outflow obstruction, which, in the opinion of the investigator, requires surgery
* Long acting nitrates
* Oral or intravenous steroids therapy
* Insulin - dependent diabetes mellitus
* Recipient of any major organ transplant (eg, lung, liver, heart) or renal replacement therapy
* Malignancy (unless healed or remission \> 5 years)
* Anaemia (Hb\< 10g/dl)
* Known to be human immunodeficiency virus (HIV) positive or active virus - hepatitis
* Alanine transaminase (ALT) or aspartate transaminase (AST) \> 3 times the upper limit of the normal range
* Known hypersensitivity to Pycnogenol®
* Alcohol, nicotine abuse or illicit drug abuse
* Pregnancy or breast-feeding, women with child - bearing potential without adequate contraception
* Disease with systemic inflammation (e.g. rheumatoid arthritis, M. Crohn)
* Participation in another study within the last month
Do Sulphonylureas Preserve Cortical Function During Hypoglycaemia?

To see if using medication called sulphonylureas can help improve symptoms which patients rely on to recognise low blood glucose levels ( hypoglycaemia) and also to see if they can reduce the slowing down in brain function which occurs at hypoglycaemia.

Low blood glucose (hypoglycaemia) is the most common and important side effect of insulin treatment for diabetes. Most episodes are "mild" and lead to symptoms that alert the individual to raise their blood sugar level by consuming sugar or starch (carbohydrate). The body also responds to low blood sugars by producing hormones such as adrenaline and cortisol, which help to restore blood sugar levels to normal. As the brain relies on sugar for fuel, it does not function properly if blood sugar levels drop too low, resulting in confusion and in extreme cases reduced conscious levels.

Repeated hypoglycaemia can blunt the protective symptoms and hormonal responses to hypoglycaemia limiting patients' ability to recognise and correct hypoglycaemia, putting them at high risk of even more hypoglycaemia (Heller and Cryer, 1991).

Sulphonylureas are tablets used to treat type 2 diabetes that work by stimulating the pancreas to make more insulin. They do this by closing pores called KATP channels which are found on the surface of many cells and control the rate of firing of cells. In the pancreas, closing them causes cells to fire and release insulin. However, in other tissues such as in the brain, these channels have a protective function and they open up during times of lack of fuel, such as lack of oxygen or sugar, preventing the cells from firing and putting them into a resting mode which reduces their energy requirement(Dunn-Meynell, Rawson and Levin 1998). However, if the brain cells responsible for generating symptoms are put into this resting mode, they may not produce symptoms, which may contribute to hypoglycaemia unawareness.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75
* Type 1 diabetes (WHO definition) of at least 5 years duration
* History of impaired awareness of hypoglycaemia (capillary glucose readings \< 3.5mmol/l without symptoms on \> 3 occasions in the past 3 months (those with intact symptoms will be unlikely to show an improvement and would not really benefit from taking any medication intended just to increase symptoms)

Exclusion Criteria:

* Pregnancy
* Severe systemic illness
* Active malignancy
* Severe complications of diabetes such as severe visual impairment, severe renal impairment, severe symptomatic autonomic neuropathy
* Untreated ischemic heart disease, recent stroke
* Lactose intolerance ( the placebo will contain lactose)
* Very poor diabetes control (HbA1c \> 10%) Liver disease ( increase in ALT / AST \> 3x ULN)
* Chronic Kidney Disease stage 4 or 5 ( eGFR \< 30ml/min)
* Severe untreated thyroid or adrenal insufficiency ( must be treated and on stable doses for at least 6 weeks)
4P: Persistent Postoperative Pediatric Pain

For children, adequate perioperative pain management is a right according to the UN convention on the rights of the child, a law in Sweden since 2020. Despite this, children are still under-treated in many cases. In addition to great suffering, this can lead to missing school and a long-term burden on the society.

ESPA, the European Society for Pediatric Anesthesia, has drawn up guidelines for perioperative pain management. With the study 4P: Persistent Postoperative Pediatric Pain, we want to investigate whether these guidelines are followed and how many children develop long-term pain postoperatively.

In order to map the prevalence of pain after surgery in children in Sweden, the investigators plan to include and follow 2000 children in southern Sweden who undergo surgery. The study provides a unique opportunity to follow a large number of children, evaluate given per- and postoperative pain treatment and identify factors linked to the development of acute and long-term postoperative pain. Our goal is to optimize peri- and postoperative pediatric pain management to promote rapid recovery after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 1-17 years
* Scheduled surgery for hernia, penile surgery, retentio testis, adenotonsillectomy, appendectomy or acute fracture in southern Sweden.
* Informed consent

Exclusion Criteria:

* Scheduled for several surgeries within the time-frame
* Inability to understand swedish
* Inability to understand the meaning of participation.
Initial Pilot Study to Evaluate the Safety and Temporary Symptom Improvement Efficacy of CKD-981

The purpose of this study is to prove that the temporary symptom improvement effect on knee osteoarthritis using CKD-981

The aim of this pilot study is to evaluate the efficacy and safety of CKD-981 in patients with mild to moderate degenerative knee osteoarthritis who have been experiencing pain more than 8 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patients between 40 years and 80 years old
* Patients who have experiencing knee pain more than 8 weeks
* VAS more than 40 mm
* Kellgren and Lawrence grade 2 and 3 in X' ray knee joint

Exclusion Criteria:

* Previous knee surgery in affected side
* Patients with Rheumatoid arthritis, connective tissue disease, Paget's disease
* Infection of knee joint
* BMI more than 35kg/m2