cyrilzakka/clinical-trials huggingface dataset:
Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain

This is an observational clinical study aiming to further the wider understanding of patients who develop persistent pain after Thoracoabdominal Aorta surgery, a surgical cohort who are disproportionately affected. This will be undertaken through a prospective biopsychosocial characterisation of the phenotype of patients undergoing this operation.

Increasing numbers of patients are undergoing surgery on the chest for treatment of heart or lung cancer disease. Over the last twenty years, the medical community has become increasingly aware of the long-term effect of this surgery in producing persistent pain, approximately half of all survivors are still in pain around their surgical incision at three months postoperatively and beyond. There is currently no accepted method for preventing this phenomenon.

The nervous system mechanisms for the development of persistent pain after surgery are unclear. Some studies suggest it may involve the patient's ability to dampen down pain signals travelling from the incision site to the brain.

Humans have an in-built system that produces opiates as well as other pain-relieving molecules in response to injury, e.g. surgery. However, this response varies hugely from person to person and may even be impacted by the psychological state of the individual at the time of surgery. Some of these pain modulating mechanisms can be measured before and after surgery in patients using sensory testing, a robust and established objective method to assess patients'.

Identifying patients who are most at risk of a persistent pain state will allow both academics and clinicians to investigate and better target appropriate treatments.

Undertaking these longitudinal observational assessments will facilitate an improved mechanistic insight of the transition from acute to pathological pain, with the ultimate goal of improving outcomes for patients'.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions

Exclusion Criteria:

* Unwilling or unable to give consent, Age \<18 years
Phase II Study of Safety and Feasibility of Intensive Blood Glucose Control With Insulin on Acute Medical Wards

Patients with chronic obstructive pulmonary disease (COPD) are commonly admitted to hospital with exacerbations of their lung disease. A combination of the acute illness and treatment with oral steroids causes a rise in blood sugar. Patients with high blood sugar do worse than those with normal blood sugar. The aim of this study is to develop a safe and effective protocol for tight control of blood glucose with insulin on acute medical wards outside the intensive care environment. This will allow us to perform a formal trial to determine whether blood glucose control with insulin reduces death and complications from COPD exacerbations.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of AECOPD as primary cause for admission
* Able to enter study within 24 hours of admission

Exclusion Criteria:

* Intensive care unit admission
* Moribund or not for active treatment
* Admission expected to last \<48 hours
* Unable or unwilling to give informed consent
* Known Type I diabetes mellitus
* Patients with reduced awareness of hypoglycaemia including reduced Glasgow coma scale or those taking beta blockers
* Patients with renal or hepatic failure at increased risk of hypoglycaemia
To Evaluate Patient Preference of Movantik and Polyethylene Glycol 3350 for Opioid Induced Constipation

The purpose of this study is to determine whether patients with opioid induced constipation prefer treatment with naloxegol (Movantik) or with Polyethylene Glycol 3350.

This study is a prospective, randomized, open-label crossover study consisting of a 1-week washout period, a 2-week treatment period, another 1-week washout and a final 2-week treatment period. The study will assess the overall patient preference Movantik versus Polyethylene Glycol 3350 for the treatment of their opioid-induced constipation. This study will also evaluate the reasons for patient preference (only among subjects who indicate a preference), patient global impression of change, and change in bowel function over the treatment periods measured by Bowel Function Index. Patient's bowel movement diary will also be collected during the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between the ages of ≥18 and \<85 years
* Self-reported active symptoms of OIC (Opioid Induced Constipation) based on components of the Rome IV criteria at screening. Patients should have at least 2 of the following:

  * \<3 SBMs (Spontaneous Bowel Movements) per week
  * Straining \>25% of defecations
  * Sensation of incomplete evacuation \>25% of defecations
  * Lumpy or hard stools \>25% of defecations
  * Sensation of anorectal obstruction/blockage \>25% of defecations
* Confirmed OIC by BFI (Bowel Function Index) ≥30
* Stable maintenance opioid regimen consisting of a total daily dose of at least 30 mg of oral morphine, or equivalent of 1 or more other opioid therapies
* Willingness to stop all laxatives and other bowel regimens other than specified rescue medication

Exclusion Criteria:

* Pain related to cancer or has a history of cancer within 5 years
* Current constipation or chronic constipation not caused by or related to use of opioids
* History of rectal evacuation disorders, surgery or procedures that can potentially affect pelvic floor function; requirement of using manual maneuvers to facilitate a bowel movement
* Evidence of significant GI structural abnormalities, acute or chronic GI conditions that could post risk to the patient or confound the study results
* Recent surgery that may affect GI motility or increase risk for bowel obstruction or perforation
* Severe hepatic impairment
* Moderate or severe renal impairment
* Condition that may affect the permeability of blood-brain barrier
* Concomitantly using strong or moderate CYP3A4 inhibitors and strong CYP3A4 inducers
* Any other significant and/or progressive medical, surgical, psychiatric, or mental health condition or any significant laboratory findings that could increase the risk of participation in the study or affect the interpretation of study data as determined by the Investigator
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors

This research study will test the effects of Q CAN PLUS powder on serum lipids, selected inflammatory and oxidative parameters and genome-wide methylation

The purpose of this research study is to investigate the effects of a dietary supplement from soybeans that might help in managing heart disease. The rationale for this study is to reduce the risk factors of heart disease in high risk individuals by using soy supplements. The dietary supplement intervention trial is a randomized, 2x2 cross over design with 24 subjects in free-living conditions. There will be a two week run-in (acclimation period) after which subjects will be randomized to receive either QCAN powder or placebo powder for 12 weeks. Following a two week wash out period, subjects will be switched over(cross over) to alternate treatment. Thus, the interventions of the study will last for a total of 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 29-75 years of age
* At high risk for cardiovascular disease, i.e. with 2 or more risk factors:
* Present tobacco smoker
* Arterial hypertension (BP ≥ 140/90 mm Hg or treatment)
* LDL-cholesterol ≥ 110 mg/dl
* HDL-cholesterol ≤ 40 mg/dl
* Triglycerides ≥ 150 mg/dl
* Fasting blood glucose ≥ 110 mg/dl
* Overweight or obesity (BMI ≥ 25 kg/m2)
* Family history of premature heart disease

Exclusion Criteria:

* Uncontrolled renal, hepatic, or endocrine disease
* Abnormal blood chemistry profile
* Familial hypercholesterolemia or other genetic dyslipidemia
* Intake of lipid-lowering drugs and dietary products including plant sterols/stanols
* High Framingham risk or medical condition in which statin therapy is considered necessary by a treating physician
* Hypersensitive or allergic to soy or cellulose
* Alcohol or drug addiction or abuse
* Diabetes
* Lack of ability or interest to follow the dietary intervention
Follow-up of Eating Disorder Patients From a 15-year Period.

Retrospective follow-up study of former eating disorder patients in child- and adolescent psychiatry on psychiatric symptoms and social intelligence.

Former patients and their parents were contacted 3 to 15 years after their completed treatment for eating disorders at Levanger Hospital, Child and Adolescent Psychiatry Department, in the period from 1988 to 2002. Interviews focusing on general psychiatric symptom, specific eating disorder symptoms, social intelligence and consumer satisfaction. Parents were also contacted and interviewed on consumer satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Eating disorder symptoms or disorder

Exclusion Criteria:

-
Antiviral Prophylaxis and Infant Vaccination to Prevent Perinatal Hepatitis B Infection

Most new hepatitis B virus (HBV) infections are acquired perinatally. In this study, pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate during the last trimester of pregnancy and for two months following delivery. Their infants will receive hepatitis B (HB) immunization, starting with a first dose soon after birth. We hypothesize that the risk of mother-to-child transmission of HBV will be lower than 2%. The results of the study will help define policy to manage HBV infected pregnant women to prevent perinatal transmission.

This is a prospective multi-center, multi-country (Thailand and Lao PDR), open-label, single arm clinical trial in HBsAg and HBeAg positive pregnant women (from 28 weeks until one year postpartum) and their infants (until 18 months of age). Pregnant women with HBsAg and HBeAg will receive tenofovir disoproxil fumarate 300 mg once daily from 28 weeks of pregnancy until two months postpartum. Their infants will receive hepatitis B (HB) immunization, starting with the first dose soon after birth.

The study aims to show that substituting maternal antiviral treatment for infant HBIg can be favorably considered in settings where HBIg plus vaccine has been used as well as in settings where only vaccine is used. A significant improvement over the standard HBIg + vaccine strategy would be that adding an antiviral strategy results in less than 2% transmission. A total of 499 women and their infants will be enrolled in public hospitals in Thailand and Lao PDR.

The study will be monitored by a Data and Safety Monitoring Board (DSMB) at least annually.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy
* Age ≥18 years
* Negative HIV antibody test during current pregnancy
* Positive HBsAg test during current pregnancy
* Positive HBeAg using a rapid test during current pregnancy
* Absence of clinical symptoms of liver disease
* Gestational age of 28 weeks (+/- 7 days) based on the obstetrician judgment guided by the review of the date of last menstruation period.
* Willing and able to provide written informed consent
* Agreeing to bring her infants(s) at the planned study visits at one of the study site until the last visit (18 months after birth) and to inform the site investigators if plans to move to another place and not be able to return to the clinic
* Understand the need for adequate infant immunization for her infant(s) and accept that blood draws will be performed to determine the infant HBV infection status

Exclusion Criteria:

* Receipt of anti-HBV antivirals at any time during the last 9 months
* Known liver cirrhosis or evidence of hepatocellular carcinoma
* Creatinine clearance \<50 ml/min, calculated using the Cockcroft-Gault formula
* Confirmed dipstick proteinuria \>1+ (\>30 mg/dL) or normoglycemic glycosuria
* Evidence of pre-existing fetal anomalies incompatible with life
* Any concomitant condition or treatment that, in the view of the clinical site investigator, would contraindicate participation or compromise adherence to treatment and satisfactory follow up in the study.
Chicken Model in Teaching Episiotomy Repair

The aim of this study is to determine the effect of chicken use in episiotomy repair training of midwifery students on students' satisfaction, self-confidence and anxiety levels.

Hypotheses H01 There is no difference between the satisfaction score of the chicken group and the satisfaction score of the control group in episiotomy repair training.

H02 In episiotomy repair training, there is no difference between the self-confidence score of the chicken group and the self-confidence score of the control group.

H03 There is no difference between the anxiety score of the chicken group and the anxiety score of the control group in episiotomy repair training.


Eligibility Criteria:
Inclusion Criteria:

* Midwifery students who were registered in the midwifery department in the 2020-2021 academic year and take childbearing course,
* Students over the age of 18

Exclusion Criteria:

* Having previously received training on episiotomy and its repair,
* Students who fill in the data collection forms incompletely will not be included in the study.
The Surgical Benefit and Pt.Tolerability Between Two Different Bowel Cleansing Regimens Performed Prior to Pelvic Reconstructive Surgery. Does One Bowel Cleansing Regimen Improve the Surgeons Visual Field Significantly Better Than the Other.

Does mechanical bowel preparation (complete bowel cleansing)help the Surgeon with visualization of the operative field during laparoscopic pelvic reconstructive surgery?

Patients will be randomized to receive a complete MBP or not prior to their surgical procedure. All patients will use 1 fleets enema the night before surgery and one the morning of surgery to ensure that the rectum is empty of all stool. This will be done since some surgeons use a rectal probe in the rectum to help with manipulation during the procedure. Stool in the rectal vault could contaminate the surgical field and lead to an infection.

Patients will be randomized at their pre-op visit and provided instructions according to the group assignment. On the day of surgery patients will be asked to complete a questionnaire in the pre-op holding area to assess their overnight symptoms including insomnia, weakness, abdominal distention, nausea, thirst and overall tolerability of the Bowel Preparation assigned.

Immediately after surgery, the primary surgeon will be asked to complete a visual analog score sheet evaluating the ease of the procedure with regard to retraction of the large and small bowel to help with visualization of the sacral promontory, retraction from posterior cul-de-sac, and maintaining adequate positioning after retraction. All surgeons (attendings, fellows, and residents) will be blinded re: the patients group assignment. Each primary surgeon will be asked to assign a final grade to the procedure as easy, medium, or difficult based on overall bowel retraction.

At their 2 week follow up visit patients will be asked to report return of bowel function (first bowel movement or flatus) in # of days after surgery and incidents of stool leakage post op.

Eligibility Criteria:
Inclusion Criteria:

All patients undergoing the following laparoscopic pelvic reconstructive procedures for pelvic organ prolapse:

* Laparoscopic sacrocervicopexy
* Laparoscopic sacrocolpopexy
* Laparoscopic sacrohysteropexy
* Laparoscopic uterosacral ligament suspension

Who understand and are willing to comply with the study requirements, including agreeing to answer the preoperative and postoperative questionnaires

Exclusion Criteria:

* Previous abdominal or laparoscopic colon surgery (not including transrectal procedures)
* History of abdominal malignancy
* History of surgical debulking for previous malignancy
* Non-english speaking
* Pregnancy
* Hx of abdomino-pelvic radiation
* Contraindications to Sodium Phosphate
* Contraindications to laparoscopic surgery
Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis

The purpose of this long-term study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea associated with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Dysmenorrhea associated with endometriosis

Exclusion Criteria:

* Severe hepatopathy
* Pregnant woman
Building a Renewed ImaGe After Head & Neck Cancer Treatment

This study will evaluate whether a time-limited cognitive behavioral therapy (CBT) intervention in the post-treatment time period can address body image disturbance (BID) in patients with surgically-treated head and neck cancer (HNC), thereby improving BID and quality of life (QOL).

The investigators will complete a single-arm, phase II pilot study of time-limited CBT on BID in patients with surgically-treated HNC. Reliable, validated patient-reported outcome (PRO) measures of BID will be collected before, 1 month and 3 months after the CBT intervention to provide preliminary data on the effectiveness of CBT for BID in patients with surgically-treated HNC, addressing this critical knowledge gap. It is expected that time-limited CBT implemented in the post-treatment period will decrease BID and improve QOL in affected patients.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of squamous cell carcinoma of the upper aerodigestive tract (oral cavity, oropharynx, hypopharynx, larynx) or cutaneous malignancy of the head and neck (e.g. squamous cell, basal cell, melanoma, etc)
* Age \> 18
* American Joint Committee on Cancer (AJCC) stages I-IV
* Curative intent therapy with surgery with or without adjuvant therapy
* Body Image Scale (BIS) score \> 5 up to 1 year post-treatment

Exclusion Criteria:

* Inability to speak English
* Known distant metastatic disease
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
A Bioequivalence Study to Compare Two Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

This study will be a single-center, randomized, parallel, open-label, single dosing bridging study in healthy subjects to evaluate bioequivalence of two formulations of SHR-1314. Subjects will be randomly assigned to the Vials group, the PFS group at a ratio of 1:1


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.Subjects must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations
* Men or women at least 18 years and no more than 45 years of age at time of screening.
* Men with a body weight ≥50 kg or women with a body weight ≥45kg, with BMI range from 18 to 25.
* Subjects with normal physical examination results and with normal laboratory results (blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray chest test are normal or with certain abnormal without clinical significance.

Exclusion Criteria:

* Presence of significant medical problems, with investigator's judge that not proper to participate clinical study
* History of hypersensitivity to any of study drug constituent
* History or current infection with human immunodeficiency virus (HIV) or hepatitis C; or current hepatitis B infection or syphilis
* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years
* History of chronic or recurrent infectious disease, or evidence of active or latent tuberculosis infection.
* Those who have participated in any clinical study for any drug or medical device within 3 months before screening
* Those who have been vaccinated with live attenuated vaccine within 12 weeks prior to screening
* History or evidence of ongoing alcohol or drug abuse, within the last six months before Baseline.
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
* Subjects judged by the investigator as unsuitable for participating in this study.
The University of Michigan Wellness for Liver Health Study

The goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with Non-alcoholic Fatty Liver Disease (NAFLD).

As there are no medications that effectively treat nonalcoholic fatty liver disease (NAFLD), effective diet and lifestyle treatments are imperative to curb this disease's impact. Our data suggests that insulin resistance is the strongest modifiable risk factor for having NAFLD. Additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of NAFLD. The investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve NAFLD reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-GG individuals. To prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* have regular access to the internet
* MRI with liver steatosis but nor cirrhosis
* Able to consent and follow directions
* No physical limitations
* Physician approval to participate
* Able to attend in-person appointments in Ann Arbor
* Be identified based on information from the Michigan Genomics Initiative (MGI) database
* have elevated liver function tests

Exclusion Criteria:

* non-English speaking
* inability to complete baseline measurements
* a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, Cushing's syndrome, etc.)
* pregnant or planning to get pregnant in the next 6 months
* type 1 diabetes
* non-NAFLD causes of elevated liver function tests
* planned or history of weight loss surgery
* vegan or vegetarian
* currently enrolled in a weight loss program or other investigative study that might conflict with this research
* taking medications known to cause weight gain or loss
* recent decompensation/hospitalization
* metal implants/inability to receive MRI
Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

The purpose of this study is to evaluate pharmacokinetics and safety after oral administration of HCP1007 capsules and Rosuvastatin plus Omega-3.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 20 and 45
* Informed of the investigational nature of this study and voluntarily agree to participate in this study
* BMI of \>20kg/m2 and \<26kg/m2 subject

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
* Participation in another clinical study within 60 days prior to start of study drug administration