cyrilzakka/clinical-trials huggingface dataset:
A New Measure of Body Image in Eating Disorders

This study aims to compare a new electronic instrument called (here referred to as the 'Body App') with traditional paper and pencil rating scales for assessing how individuals with eating disorders evaluate their body image.

Self-perceived weight or shape disturbance is a core symptom of eating disorders, with heavy therapeutic and prognostic relevance. Developing a reliable and unbiased method to assess body image disturbance is imperative, as feature characteristics of eating disorders, such as anorexia nervosa, include the overestimation of body size and shape. Among the most essential features of the disorder, this inability to correctly judge one's own body image has been frequently linked to the maintenance of eating disorders. Moreover, persistent perceptual disturbance for one's visual appearance is one of the strong predictors of relapse in AN and bulimia nervosa.

Body image disturbance can be conceptualized as having two main components: perceptual, and attitudinal/affective. These might be considered two distinct constructs, best measured independently. However, clinicians currently rely upon self-report questionnaires that evaluate aggregates of symptoms, perceptual experiences, behaviors, and thoughts linked to the disorder. Some scales selectively evaluate body image characteristics such as body dissatisfaction and body distortion. However, it is unclear to what degree each of these measures quantifies the specific components of perceptual experiences vs. attitudinal/affective aspects. This study aims to evaluate whether a new electronic instrument, here referred to as the 'Body App', which separates estimations of body shape and size from the attitudinal/affective component might result in closer approximations of the perceptual component of weight or shape disturbance, and facilitate the assessment of body image disturbance in eating disorders.

Eligibility Criteria:
Eating disorders group:

Inclusion Criteria:

* Primary clinical diagnosis of eating disorder
* Receiving inpatient treatment for eating disorder
* Body mass index greater than or equal to 14
* Independently ambulatory
* Possession of a smartphone with data plan
* English proficiency

Exclusion Criteria:

* Active suicidal ideation
* Comorbid schizophrenia spectrum or other psychotic disorder.

Healthy comparison group:

Inclusion Criteria:

* No current psychiatric diagnosis
* Body mass index greater than or equal to 14
* Independently ambulatory
* Possession of a smartphone with data plan
* English proficiency

Exclusion Criteria:

* Body mass index \> 41
* Active suicidal ideation
Montelukast Back to School Asthma Study (0476-340)

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.


Eligibility Criteria:
Inclusion Criteria:

* Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

* Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent
DNA Fragmentation - Effect on Pregnancy Rate

The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male fertility patients with increased amount of DNA fragmentation in their spermatozoa

Exclusion Criteria:

-
Effects of the Nottingham Augmented Reality (AR) App for Arthritis Hand Joint Pain

The aim of this run-in design, feasibility study is to assess outcomes (including opioid-use, pain intensity, emotional function, and general physical function) for an augmented reality illusion therapy in participants with chronic hand joint pain due to arthritis.

This is a run-in design, feasibility study that uses the enrolled participants as their own control. After consenting to join the study, for the first 30 days, participants will be on their current Standard of Care (SoC). Then, for the next 30 days, the same group of participants will use the Nottingham digital treatment daily. Pre- and Post-SoC and Treatment period measures of opioid use and pain, quality of life measures will be administered and measured. Additionally, for qualifying participants, Pre- and Post-treatment functional Magnetic Resonance Imaging (fMRI) scans will be performed to assess how Nottingham AR therapy affects neuroplastic changes in the supraspinal pain network associated with the therapy sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults ages 21-80
2. Clinical diagnosis of chronic hand pain from arthritis or as determined by study physician 3) Hand joint pain at a severity of 4 and above (on a 0 to 10 scale) daily

4) Use of prescribed opioids 5) English-speaking, literate, with stable residence 5) Able to operate a smartphone as evidenced by direct observation.

Exclusion Criteria:

1. Major medical illness that might confound effects of pain on function (e.g., advanced cardiac or pulmonary disease)
2. Current active alcohol or substance use disorder as evidenced from medical record
3. Currently active unstable psychiatric status in previous three months as measured by direct observation, patient self-report, or medical record
4. Moderate or severe cognitive impairment as demonstrated by medical diagnosis or clinical observation
5. fMRI exclusion only: Any factors that would prevent participation in fMRI
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.


Eligibility Criteria:
Inclusion Criteria:

* Patients are over 18 years of age.
* Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV)
* The patient, or his/her representative, has agreed to the informed consent.

Exclusion Criteria:

* The patient, or his/her representative, is unwilling or unable to agree to the informed consent.
Topical Bimatoprost Effect on Androgen Dependent Hair Follicles

The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies.

Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.


Eligibility Criteria:
Inclusion Criteria:

1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA.
2. Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography.
3. Good health with normal blood tests for hematological, renal, and liver function.
4. Able to return to Duke for study visits.

Exclusion Criteria:

1. ECOG \>1.
2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months.
3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month.
4. Taken any chemotherapy in the past 2 years.
5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months.
6. Used prostaglandins of any type in the past or currently.
7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions.
8. Any skin abnormalities in the target area that would effect hair growth.
9. Any history of glaucoma or elevated intraocular pressure (IOP).
10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.
Analgesic Efficacy of Dexmedetomidine Added to Fentanyl in PCEA

Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

The aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge.

Thoracic epidural anesthesia (TEA) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, TEA's effects on the postoperative neurohumoural stress response, cardiovascular Pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years.

dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (21 years old or more),
* classified as American Society of Anesthesiologists (ASA) grade II and III,
* scheduled for elective major abdominal cancer surgery.

Exclusion Criteria:

* patients with coagulopathy,
* active neurological disease,
* cutaneous disorders at the epidural insertion site,
* allergy to the study medication
* and patients refusal.
Establish a "Taiwan Rare Disorder Tissue Bank", to Collect and Repost Biological Samples and Disease Information From Patients With Rare Disorders

Even though rare disorders usually have limited case numbers, they have induced huge impacts on patients and their families, and has heavily burdened on our society and healthcare system as well. Therefore, it is essential to detect the occurrence of disorders and thus take appropriate measures as early as possible. The preventive goal is based on comprehensive understanding on rare disorders, available diagnostic and therapeutic approaches. However, studies related to rare disorders are often impeded by limited sample sizes and infrequent exchange of research materials among institutes. After referring to foreign experiences, the investigators have noticed that a non-profit tissue bank which can reposit biological samples and thus provide researchers access to samples, may be a solution. Through sharing this public asset, the investigators believe not only quantity and quality of rare disorder studies will be improved, the collaboration between various research institutes can also be strengthened afterwards. Most important of all, those achievements can ultimately benefit patients, families and the whole society.

Investigation Plan

1. Study Period：From 2009 to 2013
2. Study Population：Patients with rare disorders.
3. Planned Number of Subjects： 300\~500 Subjects will be included in CMU.
4. Inclusive Criteria：A patient who is clinically diagnosed as one of rare disorders notified by Department of Health or our organization. Or a patient who is diagnosed as a probable rare disorder case by physicians.
5. Exclusive Criteria：Patients whose physical or mental status is not suitable by the judgment of health professionals. Or a patient who is \<20 years old or interdictory, yet without getting the permission from his/her legal representatives.
6. Study Site： Mainly in OPD that related to rare disorders.
7. Study Materials：Blood (for plasma, DNA and cell line), a questionnaire and a chart review form. Tissue samples are acceptable as well.
8. Application of collected materials：Samples and information will be restored in appropriate manner, and researchers will be encouraged to apply them for biological studies in the field of rare disorders thereafter.

Eligibility Criteria:
Inclusion Criteria:

* A patient who is clinically diagnosed as one of rare disorders notified by Department of Health or our organization. Or a patient who is diagnosed as a probable rare disorder case by physicians.

Exclusion Criteria:

* Patients whose physical or mental status is not suitable by the judgment of health professionals. Or a patient who is \< 20 years old or interdictory, yet without getting the permission from his/her legal representatives.
An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT)

The purpose of this study is to evaluate the impact of the Abbott Sensor Based Glucose Monitoring System on hypoglycaemia compared to Self Monitoring Blood Glucose (SMBG) testing using a randomised controlled study design in adults with Type 1 diabetes using insulin.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Type 1 diabetes for ≥ 5 years
2. On their current insulin regimen for ≥ 3 months prior to study entry
3. Screening HbA1c result ≤ 7.5% (58 mmol/mol)
4. Reports self testing of blood glucose levels on a regular basis equivalent to a minimum of 3 times daily for at least 2 months prior to study entry
5. In the investigator's opinion the subject is considered technically capable of using the Abbott Sensor Based Glucose Monitoring System
6. Aged 18 years or over.

Exclusion Criteria:

1. Subject has been diagnosed with hypoglycaemic unawareness (i.e. subject has a diagnosis of impaired awareness of hypoglycaemia recorded in their medical notes OR in the investigator's opinion the subject currently experiences less than minimal warning symptoms for impending hypoglycaemia)
2. Subject is currently prescribed animal insulin
3. Subject is currently prescribed oral steroid therapy or is likely to require oral steroid therapy for any acute or chronic condition during the study
4. Has known allergy to medical grade adhesives
5. Currently participating in another device or drug study that could affect glucose measurements or glucose management
6. Currently using a Continuous Glucose Monitoring (CGM) device or has used one within the previous 4 months
7. Currently using Sensor augmented pump therapy
8. Is planning to use a CGM device at any time during the study
9. A female subject who is pregnant or planning to become pregnant within the study duration
10. A breast feeding mother
11. Currently receiving dialysis treatment or planning to receive dialysis during the study
12. Has a pacemaker
13. Has experienced an acute myocardial infarction within previous 6 months
14. Has a concomitant disease or condition that may compromise subject safety including; unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any other uncontrolled medical condition
15. Has experienced an episode of confirmed or suspected diabetic ketoacidosis (DKA) in the previous 6 months
16. In the investigator's opinion, the subject is considered unsuitable for inclusion in the study for any other reason.
To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms

The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.

Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 18 to 80 years, male or female;
* Patients diagnosed as wide-neck intracranial aneurysms by brain CTA/MRA/DSA (neck width≥4mm or bodyor a dome-to-neck ratio\<2);
* Parent vessel with a diameter of ≥2.5mm and ≤4.5mm;
* Patients target aneurysm is planned to be embolized using intracranial stent assisted with coiling;
* The mRS Score of the patients was 0-2;
* Patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent.

Exclusion Criteria:

* Patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment.
* Patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography.
* Known to be allergic to Nitinol platinum alloy and angiographic agents.
* Conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation.
* Patients combined moyamoya disease, intracranial tumor, intracranial arteriovenous malformation, intracranial arteriovenous fistula and intracranial hematoma.
* The target aneurysm has previously received intravascular embolization or stent implantation treatment;
* Multiple aneurysms or complex aneurysms;
* Patients with acute ruptured aneurysm;
* Serious infection is not controlled and is not suitable for operation;
* Patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery;
* Obvious abnormal coagulation function or bleeding tendency;
* Combined with severe renal insufficiency, creatinine greater than or equal to 200umol/L; Patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or ALT more than 3 times the upper normal limit;
* Pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period;
* Participation in any other clinical trial within 30 days prior to signing informed consent;
* Other conditions considered by the investigator to be inappropriate for enrollment.
A Study to Evaluate the Pharmacokinetics and Safety Between HCP1902 and Co-administration of RLD2007, RLD2008

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP1902 and co-administration of RLD2007/RLD2008 in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Age 19\~54 years in healthy volunteers 19 kg/m\^2 ≤ BMI \< 28 kg/m\^2, weight(men) ≥55kg / weight(women) ≥45kg
* 90 mmHg ≤ SBP \<140 mmHg, 50 mmHg ≤ DBP \<90 mmHg
* agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
* Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who judged ineligible by the investigator
LARS for Chinese Patients

Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Considering varieties and differences of patient characteristics between Chinese patients and the western ones, this retrospective study aims to investigate the incidence of LARS in Chinese patients undergoing laparoscopic LAR, and to explore perioperative risk factors that might be associated with major LARS. Consequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with LARS questionnaire. Incidence of LARS and patient data were collected and analyzed.


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed as rectal cancer and underwent radical laparoscopic LAR and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team

Exclusion Criteria:

either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to LARS questionnaire
Optimal Positioning of Local Anaesthetic in Femoral Nerve Block Prior to Hip Surgery

The aim of the study is to compare patient comfort and analgesic efficacy of ultrasound guided femoral nerve block using the following endpoints: circumferential spread, anterior or posterior local anaesthetic deposition prior to positioning for spinal anaesthesia for operative fixation of fractured neck of femur.

Fractured neck of femur is a common cause of admission to hospital in elderly patients and requires operative fixation. The recommended anaesthetic technique for these cases is spinal anaesthesia, which is performed with the patient in lateral decubitus. Positioning the patient prior to administering spinal anaesthesia is the most painful manouvre due to the movement of the fractured bone.

Regional anaesthesia is effective in alleviating pain due to trauma, and it has the advantage of producing localized but complete pain relief (1). Femoral nerve blockade prior to positioning for spinal anaesthesia provides excellent pain relief and is a well tolerated procedure (2-5).

Using ultrasound guided femoral nerve block is a relative new method to improving the block success rate. It is widely used in our hospital. In a recent study Casati and al. showed a 42 % decrease of ED50% using ultrasound for localization of the femoral nerve (6). In a recent editorial by Brian D. Sites was mentioned that the positioning of the local anaesthetic in ultrasound guided blocks is unclear (7). We currently follow different patterns in relation to injection of the local anaesthetic solution around the femoral nerve. One of them is a circumferencial spread around the nerve. This, however, needs several needle passes which are likely to be painful for the patient. Another option is injecting the local anaesthetic on one side, above or below the nerve without changing the position of the tip of the needle, avoiding patient discomfort. Whether this results in a comparable quality of sensory block is unknown. The femoral nerve is separated in branches at this level and we assume that the spread of local anaesthetic may influence the quality and the distribution of the block. We propose to study the characteristics of femoral nerve block in relation to different patterns of local anaesthetic injection (circumferencial, inferior or superior).

Eligibility Criteria:
Inclusion Criteria:

* Fractured neck of femur surgical fixation performed under spinal anaesthesia
* ASA I to III

Exclusion Criteria:

* Patient refusal
* Coagulation disorders
* Head injury or other associated injuries
* Previous vascular surgery in the femoral area.
* Loss of consciousness and signs of acute coronary syndrome
* Mini-Mental Score \< 25 (see appendix 3)
* Allergy to lignocaine,
* Skin lesions/infection at site of injection
* Sepsis