cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of HB0017 in Patients With Moderate to Severe Plaque Psoriasis

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis.

This is a randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the efficacy and safety of HB0017 in subjects with moderate to severe plaque psoriasis. The study will consist of 3 periods: up to 5 weeks screening period, 28 weeks treatment period, 8 weeks Safety Follow-Up period.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent
* Diagnosis of chronic plaque psoriasis with or without psoriatic arthritis for at least 6 months prior to Screening
* Psoriasis Area and Severity Index(PASI)\>=12 and body surface area(BSA) \>=10% and static Physician's Global Assessment (sPGA) score 3 or greater on a 5-point scale
* Candidates for systemic psoriasis therapy and/or phototherapy and/or chemo phototherapy
* Women who are at childbearing age(not pregnant or breast-feeding), and subjects and their partners voluntarily use contraceptive methods deemed effective by the investigator during treatment and for at least 6 months after the last study medication

Key Exclusion Criteria:

* Forms of psoriasis other than chronic plaque psoriasis.
* History or evidence of active tuberculosis, Patients with evidence of latent tuberculosis may enter the trial after sufficient treatment according to protocol.
* Positive results of confirmatory serology test for hepatitis B, hepatitis C, HIV or syphilis at screening.
* History of a serious or systemic infection within 4 weeks before screening.
* History of malignancy of any organ system within the past 5 years.
* Inadequate washout period for prior drug therapy.
* Previous use of secukinumab, ixekizumab or any other drug that targets Interleukin 17( IL-17) or IL-17 receptor.
* Any medical conditions, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with study participation or study results interpretation.
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate
* Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S5.
* Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT)

Exclusion Criteria:

* Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin
* LVEF \< 50%
* Significant Cardiac History
* Brain Metastases
* Contraindication for MR imaging (as incompatible implanted metallic device, weight \>250 lbs etc) or known intolerance or allergy to MRI contrast agents.
A Prognostic Transcriptomic Signature for Chronic Hypersensitivity Pneumonitis

Up to 135 patients with hypersensitivity pneumonitis will be enrolled at 7 clinical centers across the United States. Patients will be followed for 24 months to determine if biomarkers in the blood can predict disease progression.

Hypersensitivity pneumonitis is an immunologically mediated form of lung disease, resulting from inhalation exposure to a large variety of antigens. For unknown reasons, a subgroup of patients with HP without a known inciting antigen exposure develops chronic disease with progressive pulmonary fibrosis (the leading cause of death). Accurately identifying patients at risk of disease progression is necessary for prognosis and therapy.

Enrolled subjects will be followed for 24 months and complete 5 visits to one of the study centers. Blood biomarkers will be collected in addition to other clinical data to determine if these biomarkers can predict disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic hypersensitivity pneumonitis
* Age 18 through 85 years.
* Diagnosis of chronic hypersensitivity pneumonitis by HRCT
* Able to understand and sign a written informed consent form.
* Able to understand the importance of adherence to the study protocol and willing to follow all study requirements

Exclusion Criteria:

* Not a suitable candidate for enrollment or unlikely to comply with the requirements of this study
* Known explanation for the interstitial lung disease
* Clinical diagnosis of any connective tissue disease
* Listed or expected to receive a lung transplant within 4 months from enrollment
* Pregnant women
The Effect of Sex Education on Sexuality of Pregnant Women

Aim: In this study, it is aimed to determine the effect of sexual education given to pregnant women on attitudes towards sexuality and sexual response during pregnancy.

The study will be carried out in two different groups. After the women are evaluated in terms of eligibility criteria for the research, the eligible pregnant women will be informed about the research and written informed consent will be obtained from those who accept. Random distribution of pregnant women to study groups will be made using the Block Randomization method. The following applications will be made to the groups.

Education Group: Women in the experimental group will be given education on sexual life during pregnancy. Before the training, preliminary data will be collected and then the participants will be given two hours of individual and face-to-face training.

At the end of the training, homework will be given to pregnant women to practice at home, including "sharing their sexual feelings and thoughts with their spouse, sharing problems and concerns about sexuality during pregnancy, and using alternative ways other than sexual intercourse. In addition, a "Sexual Life in Pregnancy Information Booklet" will be given, and they will be asked to read the information in the booklet and share it with their spouses. After 4 weeks, the data sheets will be applied again.

Control Group: Patients in the control group of the study will not be subjected to any treatment other than the routine procedure. Data collection forms will be applied to the patients in the control group at the beginning of the study and after 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Primigravida
* Having a singleton pregnancy
* Being between 14 -22 weeks of pregnancy
* Living with their partner

Exclusion Criteria:

* Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
* Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
* Use of psychiatric drugs
* Pregnant woman or her partner has a previous diagnosis of sexual dysfunction
* Having a risky situation where sexual intercourse is prohibited during pregnancy by the physician
* Use of psychiatric drugs such as antidepressants
Fatty Liver and Obstructive Sleep Apnea

Non-alcoholic fatty liver disease is associated with obstructive sleep apnea. Abnormalities in liver enzymes can improve following continuous positive airway pressure in patients with obstructive sleep apnea. Computerized tomography can be used to quantify fatty liver changes. We hypothesize that continuous positive airway pressure can reduce morphologic fatty liver changes in patients with obstructive sleep apnea and non-alcoholic fatty liver, an that this reduction can be evident using computerized tomography


Eligibility Criteria:
Inclusion Criteria:

* Obstructive sleep apnea, defined as AHI\>5/h

Exclusion Criteria:

* Consumption of more than 20 grams of alcohol per 24 h
* Known autoimmune disease
* Usage of known hepatotoxic drugs
* Medical history positive for viral hepatitis or other chronic liver disease
Eggs as Part of a Healthy Breakfast

Contrary to popular belief, previous studies have demonstrated beneficial effects of whole egg consumption in modifying biomarkers indicative of a greater risk of coronary heart disease (CHD), chronic inflammation, and insulin resistance. The following study is designed to conduct a comprehensive evaluation of consuming an egg-based breakfast compared to an oatmeal-based breakfast on lipid biomarkers, oxidative stress, inflammation, insulin sensitivity, and satiety in young, healthy men and women. The investigators hypothesize that the consumption of 2 eggs per day will not negatively impact plasma lipids in a young, healthy population.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-30, willing to consume eggs and oatmeal daily, proficient in English, and with a healthy lipid profile.

Exclusion Criteria:

* Currently have liver disease, renal disease, diabetes, cancer, history of stroke or heart disease
* Currently taking glucose lowering drugs or supplements
* Plasma triglycerides \>500 mg/dL, glucose \>126, total cholesterol \>240
* Pregnant, lactating, or have endocrine or metabolic disorders
* BMI ≥ 30
* Blood pressure \> 140/90 (average of 3 readings)
* Allergies to eggs
* Celiac disease or gluten sensitivity
System for High-Intensity Evaluation During Radiotherapy

This quality improvement project will evaluate the implementation of a previously described intervention (twice per week on-treatment clinical evaluations) in a feasible fashion using a previously described machine learning algorithm identifying patients identified at high risk for an emergency visit or hospitalization during radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

• started outpatient radiation therapy with or without concurrent systemic therapy at Duke Cancer Center

Exclusion Criteria:

* undergoing total body radiation therapy for hematopoetic stem cell transplantation
* undergoing therapy as inpatient
* treating physician who opted out of randomization
* completed radiation therapy prior to algorithm execution
Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator

The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.

This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .

Eligibility Criteria:
Inclusion Criteria:

* Medical student at the University of Geneva

Exclusion Criteria:

* Previous laparoscopic experience
* Stereoblindness
A Comparison of Surgical Outcome Following Drug-induced Sleep Endoscopic Diagnosis Using Propofol or Dexmedetomidine for Sedation : A Prospective Randomized Trial

Obstructive sleep apnea is a common disease, associated with cardiovascular disease, cerebrovascular disease, and many other medical conditions. Therefore the precise diagnosis and treatment are important. With drug-induced sleep endoscopy (DISE), the three-dimensional evaluation of upper airway and airway obstruction could be possible. The problem of the DISE is that there is the difference between a sedative-induced sleep and normal sleep. Moreover there were no standard sedation protocol of DISE. Propofol has short half-life, about 3 minutes, so the patients could recover quickly from it. In recent years, using target controlled infusion(TCI) of propofol, the effective effect-site concentration for DISE could be reached easily with hemodynamic stability and minimal toxic effect. In a previous pilot study, the endoscopy for the diagnosis of sleep apnea could be done successfully with propofol TCI. However there were some desaturation events, although the EEG showed that the patient was not in deep sleep enough. Therefore we thought that not only further study of propofol for DISE but also the study of other drugs for DISE will be needed to overcome this limitation. Dexmedetomidine, the selective α2-adrenoreceptor agonist, has analgesic effect and almost no respiratory depression, therefore it could be a good alternative drug for DISE. The purpose of this study is designing the appropriate sedation protocol for DISE using propofol or dexmedetomidine, and enabling the safer and more accurate DISE.


Eligibility Criteria:
Inclusion Criteria:

* ASA class 1, 2
* Age ≥ 20 yrs
* undergoing drug-induced endoscopy

Exclusion Criteria:

* patient's reject
* patients with hearing impairment or neurological deficits
* patients taking medicine that can affect the central nervous system
* History of adverse drug reactions
* Glasgow coma scale ≤ 15
* could not undergo the endoscopy
* could undergo the endoscopy, but do not undergo UPPP
Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy

Achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. To observe the effectiveness of dry needling in the PGM of the gastrocnemius muscle, in the short and medium term, on the intensity of pain in gastrocnemius muscle, in the short and medium term, on pain intensity in patients with patients with Achilles tendinopathy, compared to the application of ultrasound-guided percutaneous electrolysis on the tendon.


Eligibility Criteria:
Inclusion Criteria:

* Signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques.
* Presence of symptoms (swelling or pain) for at least 3 months.
* Positive Achilles tendon palpation test.
* Males and females over 18 years of age.
* Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons:
* Presence of palpable tight band.
* Local pain on pressure at the nodule of the tense band.
* Recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule.
* Limitation of range of motion.

Exclusion Criteria:

* Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study
Feasibility of Multi-modal Physical Therapy in Latino Older Adults With Moderate Knee Osteoarthritis

This is a small, pilot, pre/post evaluation study enrolling older Hispanic American adults with moderate knee arthritis to evaluate the feasibility of recruitment, retention and adherence after a multimodal 12-week, physical therapy intervention. The secondary aim is to evaluate preliminary estimates of change on physical performance and health related quality of life after the intervention.

Background: Hispanic Americans (HAs) experience more pain and mobility deficits associated with knee osteoarthritis (OA) compared to non-Hispanic whites (NHWs) and seek total knee arthroplasties at a reduced rate, thus conservative treatments are needed. Prevalence of knee OA among the older HA population is rising dramatically. There is moderate evidence that lower extremity strengthening, manual therapy and self-management training improve pain and physical performance in people with knee OA and little evidence in the HA population. We conducted a pilot prospective trial implementing a multimodal high intensity targeted strength training, manual therapy and self-management education intervention to evaluate feasibility of recruitment, retention and adherence and preliminary estimates of change on physical performance and health related quality of life (HrQOL) in HAs with moderate knee OA. If this trial is feasible and shows promise for efficacy, it may warrant further testing as a primary treatment for knee OA.

Methods: Spanish speaking older adults will be recruited from Kaiser Permanente San Francisco through a medical record search. Participants will attended 10 physical thearpy clinic visits over 8 weeks, followed by 4 weekly phone calls to assess adherence to exercise via 1-week verbal recall. Participants will be instructed to exercise 3 days per week for the study duration combining both clinic and home exercise participation. The intervention is led in Spanish and will include progressive open and closed-chain quadriceps and gluteal strengthening, progressive cycling training with short power intervals, manual therapy and self-management training.

Eligibility Criteria:
Inclusion Criteria:

1. Moderate knee osteoarthritis Defined as Kellgren-Lawrence radiographic level 2 or 3
2. People who speak Spanish as a primary language
3. Age 50 or greater
4. pass a Phone screening: Reports problems with physical performance due to knee: Answers yes to 'Are you now limited in any way in any of your usual activities because of arthritis or joint?' Reports pain in their knee: Answers 'yes' to have you had pain in your knee in last 30 days? Be able to walk inside home without a cane, be able to walk ¼ of a block without a cane and be able to go up a flight of stairs without assistance from another

Exclusion Criteria:

1. Psychiatric or behavioral comorbidity preventing participation in a group exercise program
2. History of lower extremity joint arthroplasty
3. Morbid obesity defined as body mass index of 40 or greater
4. Presence of inflammatory arthritic condition
5. Neurologic involvement impacting functional mobility
Fecal Microbiota Transplantation in Patients With Irritable Bowel Syndrome

The purpose of this study is to investigate the effect of fecal microbiota transplantation (FMT) on the symptoms of irritable bowel syndrome (IBS) patients.


Eligibility Criteria:
Inclusion criteria for patients

1. Signed informed consent
2. Fulfilled Rome III diagnostic criteria for IBS, and frequency of IBS pain or discomfort for at least 2 days a week in the last 12 weeks
3. Age: 18-65 years

Exclusion criteria for patients

1. High proportion of butyrate-producing microbiota in fecal samples
2. Known organic gastrointestinal disease (e.g. IBD)
3. Previous complicated gastrointestinal surgery
4. Non-gastrointestinal malignancy
5. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
6. Females who are pregnant or breast-feeding
7. Severe endometriosis
8. Antimicrobial treatment 4 weeks prior to first screening visit
9. Antimicrobial prophylaxis (eg. acne, urinary tract infection)
10. Regular consumption of probiotic products 4 weeks prior to randomization
11. Recently (within the last 3 months) diagnosed lactose intolerance
12. Celiac disease
13. Abuse of alcohol or drugs
14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial

Inclusion criteria for donors

1. Signed informed consent
2. High-butyrate producing microbiota in fecal samples
3. Age: 18-65 years

Exclusion criteria for donors

1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhea or constipation)
2. Gastrointestinal malignancy or polyposis
3. History of major gastrointestinal surgery (e.g. gastric bypass)
4. Eosinophilic disorders of the gastrointestinal tract
5. Current communicable disease (e.g. upper respiratory tract infection)
6. Known or high risk of infectious diseases such as HIV, hepatitis A, B or C
7. Non-gastrointestinal malignancy
8. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
9. Comorbidities such as metabolic syndrome, autoimmune diseases, allergies
10. Chronic pain syndromes (eg. chronic fatigue syndrome, fibromyalgia)
11. Severe or morbid obesity
12. Use of immunosuppressive or chemotherapy agents
13. Antimicrobial treatment or prophylaxis within the last 6 months
14. Females who are pregnant or breast-feeding
15. Known clinically significant abnormal laboratory values
16. Participation in high-risk sexual behaviors
17. Abuse of alcohol or drugs
18. Tattoo or body piercing within the last 6 months
19. Travel to areas with endemic diarrhea during the last 3 months
20. Positive stool testing for C. difficile toxin, ova, parasites, Giarda antigen, cryptosporidium antigen
Endometrial Safety Study of Transdermal Testosterone (300 Mcg/Day) in Naturally Postmenopausal Women

This study is designed to evaluate the endometrial safety of a testosterone patch as treatment for low libido in naturally postmenopausal women.

Naturally postmenopausal women with hypoactive sexual desire disorder (HSDD) will be randomized into a 52-week, multicenter, double-blind (DB), parallel-group, placebo-controlled study. Patients will be stratified based on whether they use concomitant estrogen/progestin therapy and then randomized in a 4:1 ration to receive either testosterone transdermal system (300 mcg/day) or placebo. Patients using estrogen/progestin at the start of the study should maintain this therapy throughout the study; patients not using estrogen/progestin at the start of the study should not initiate estrogen/progestin therapy throughout the study. Endometrial biopsies and transvaginal ultrasounds will be collected/performed at screening and study exit for all patients. Safety will be assessed by adverse events, reports of vaginal bleeding, lipids, serum chemistry, and hematology. Physical exams, pap smears, and mammograms will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Women will be screened for study participation and must be at least one year post menopausal, 45-70 years old, in general good health, and may or may not be on hormone therapy, and must have low sexual desire which causes distress.

Exclusion Criteria:

* Women will be screened for study participation and must not be using androgen therapy or have any medical, physical, psychological, or pharmacological condition that could make participation unsafe or confound the safety evaluation.