cyrilzakka/clinical-trials huggingface dataset:
Study of ICP-105 in Solid Tumors Patients

Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.

The study consisted of a screening period, a treatment period with repeated 28-day treatment cycles (duration treatment with ICP-105), and a follow-up period (within 30 days of the last dose and post-treatment follow-up 30 days after the last visit). The recruited patients receive a single dose on day 1, then after a 3-day washout period, multiple dosing will be initiated following dose-escalation schedule. The dose-limiting toxicity (DLT) assessment period consisted of Cycle 0 (single dose and washout period) and Cycle 1 (28-day cycle).

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
* At least one evaluable disease according to RECIST1.1.
* Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist.
* Adequate bone marrow, liver, renal, and cardiovascular function.

Exclusion Criteria:

* Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors.
* Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105.
* Major surgery within 6 weeks of the first dose of ICP-105.
* Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105.
* Crohn's disease with symptoms and systemic treatment.
* Central nervous system (CNS) metastasis.
* Current clinically significant cardiovascular disease including:
* Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male).
* Known active bleeding within 2 months of screening or 6 months of bleeding history.
* Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism.
* Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection.
* Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting).
* Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
A Pilot Study of PrEP Acceptance Among Young Black MSM

The overarching goal of the proposed study is to determine effective outreach methods designed to recruit and improve acceptance of high-risk HIV-negative YBMSM to initiate PrEP and to identify and modify psychosocial and structural predictors of PrEP acceptance. Specifically, the objective of this pilot study is to test the feasibility of a motivational interview-based intervention designed to improve PrEP acceptance among YBMSM.

The study will occur in conjunction with standard clinical practice, which now includes offering high-risk YBMSM PrEP. If a person accepts this offer the person will be provided the service, but the person will not be asked to participate in the proposed study. Indeed, the study is designed for men who initially refuse this offer. Thus, for those who refuse researchers will offer study enrollment. For those who accept this offer and enroll, researchers will conduct baseline assessment and then randomize to I (intervention) versus C (control). Volunteers will receive the I or C condition immediately.

The intervention condition will be called MI-PrEP. This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP. The control condition is a one-hour, theory-based, one-to-one session that will help YBMSM think more about using condoms consistently and correctly with every sex partner. This is the same program that is currently being tested at Crossroads, known as Focus on the Future. Both conditions (I and C) will include the provision of free condoms and lubricants - selected from a buffet of condoms and lubricants designed to offer men a broad selection of high quality products that can optimize the "fit and feel" of condoms during sex.

After receiving the I or C condition, researchers will collect extensive contact information for the volunteer and explain to the participant that researchers will make contact each week for the next 4 weeks, at which time researchers would like the participant to return to complete a second computer-assisted self-administered survey. Thus, approximately 4 weeks (but no later than six weeks) after study enrollment, the volunteer will return to the clinic for a second assessment. At this time, a second formal offer of PrEP by the clinician will be made (note: participants may accept the initial offer at any time up until this point). For persons accepting the offer of PrEP at this time, researchers will follow standard of care procedures and administer the PrEP. Nonetheless, this person will remain in study until 6 months has elapsed since enrollment occurred. At the conclusion of that 6-month period, blood will be collected to test for PrEP levels plus self-reported adherence measures will be collected and a follow-up computer-assisted self-interview will be given.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 29 years of age
* Identification as Black or African American
* Eligible for PrEP

Exclusion Criteria:

* none
Urinary Catheter Self-care Management

It is important for healthcare professionals to be sensitive to the needs of patients undergoing urinary catheterization. Patients and their relatives should be educated, guided and supported by nurses and other healthcare professionals. The aim of this study was to determine the effect of education given to patients with urinary catheterization on urinary catheter self-care management and urinary tract infection status. is planned as an experimental research.

The most important risk factor in the development of healthcare-associated infections of the urinary system is the insertion of a urinary catheter. Because when a urinary catheter is inserted, the possibility of developing daily bacteriuria inthe patient increases. Urinary catheter application can cause the development of fungal infections as well as bacterial infections in the patient. Although most of these infections are asymptomatic and do not pose a threat, symptomatic serious infections rarely occur. may occur. There is a risk of catheter-associated urinary tract infection in both long and short-term catheterization. This risk increases as the duration of catheterization increases. According to the Nursing Regulation published in 2011 in our country, the initiatives in this direction are expected to be continued by nurses. Therefore, in this study, the knowledge and practices of patients with urinary catheter will be examined and the effect of the education given on urinary catheter self-care management and urinary tract infection status will be evaluated. It is thought that the results of the study will guide patients with urinary catheters and nurses who provide care about the care and education of patients.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer to participate in the study
* Urinary catheterization
* Being conscious
* To be able to do self-care

Exclusion Criteria:

* Not volunteering to participate in the study
* Lack of awareness
* Inability to take care of themselves
ClockWork Postpartum Weight Management Study

The ClockWork Postpartum Weight Management Pilot Study is an intervention study that will assess the feasibility, acceptability, and initial efficacy of the ClockWork intervention among women with prepregnancy overweight/obesity during the first 4 months postpartum.

Overview of Procedures. The investigators developed a prototype mobile app to monitor ClockWork target behaviors, and now aim to gain stakeholder input to refine the interface and improve usability via feedback from postpartum women who began pregnancy with obesity. In this pilot trial, women will complete baseline assessments in the first month postpartum and be randomized to either usual care or ClockWork for 4 months, then complete assessments.

Participants \& Recruitment. Given that the investigators want to initiate treatment quickly after delivery, women will be recruited at the end of pregnancy through Magee-Womens Hospital. Women will be randomized to receive either the ClockWork intervention or Usual Care. ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the circadian timing system (CTS), weight, and health and their Amount, Regularity \& Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches (Dr. Kolko Conlon or study interventionist) will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions. Usual Care does not involve any additional intervention.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Prenatal BMI greater than or equal to 25
* At least 28 weeks gestation
* English speaking
* Singleton pregnancy

Exclusion Criteria:

* Preexisting diabetes
* Use of medications known to affect weight (example, second generation antipsychotics)
* Enrolled in current weight management programming
* Recent weight loss surgery (within the past 3 years)
* Women who endorse acute psychiatric symptoms (e.g., suicidality) that warrant immediate treatment will be excluded and referred for care.
Evaluate the Safety and Efficacy of 48-Hour Infusions of HNO (Nitroxyl) Donor in Hospitalized Patients With Heart Failure

A Study to Evaluate Safety and Efficacy of Continuous 48-Hour Intravenous Infusions of HNO Donor in Hospitalized Patients with Heart Failure and Impaired Systolic Function


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Actively being hospitalized for acute decompensated heart failure
* At least 1 administration of IV diuretic for the current episode
* Be randomized within 18 hours of first dose of IV diuretic for current episode for Part 1 Cohort 1, or 48 hours for first dose for Part II Cohort II
* Have shortness of breath at rest or with minimal exertion after administration of 1 dose of IV diuretic
* Have history of heart failure and a left ventricular ejection fraction (LVEF) ≤ 40%

Exclusion Criteria:

* Systolic blood pressure \<105mm Hg or \>160mm Hg or heart rate \<50 or \>130 bpm
* Have an active infection requiring IV anti-microbial treatment
* Be hospitalized with acute coronary syndrome, coronary revascularization or acute myocardial infarction during the previous 90 days prior to screening
* Have a history of a cerebral vascular accident (CVA or stroke) or of a transient ischemic attack (TIA) during the previous 90 days prior to screening
* Suspected acute lung disease (e.g pneumonia or asthma) or severe chronic lung disease (e.g. severe chronic obstructive pulmonary disease, or pulmonary fibrosis)

Other protocol defined inclusion/exclusion criteria could apply
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Sacroiliac Dysfunction

The purpose of the research project is to compare the effectiveness of non-thrust mobilization and exercise versus thrust manipulation and dry needling in patients with sacroiliac dysfunction. Physical therapists commonly use both approaches to treat sacroiliac joint dysfunction, and this study is attempting to determine if one approach is more effective than the other.

Patients with sacroiliac pain will be randomized to receive 1-2 treatments per week for 6 weeks (up to 10 sessions total) of either: 1. High-velocity, low-amplitude (HVLA) thrust manipulation and dry needling group, or 2. conventional physical therapy (Stabilization, force closure, motor control exercises and manual therapy) group.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must report sacroiliac dysfunction, defined as:

   * Pain of any duration (acute, subacute, or chronic) in the Fortin region (the pain may also project to the groin, thigh, lower leg and/or foot; however, it may only be local Fortin region pain in some subjects).
   * Pain does NOT centralize with repeated movements or sustained postures
   * A minimum of 3 positive pain provocation tests using either the Laslett et al. (2003, 2005) or van der Wurff et al (2006) multi-test regiments:
   * 3 or more of the following 6 pain provocation tests (Laslett et al, 2003, 2005):
   * Posterior thigh thrust
   * Gaenslen's test (right)
   * Gaenslen's test (left)
   * ASIS distraction
   * ASIS compression
   * Sacral compression
2. A minimum pain rating of 2/10 using the NPRS (Numeric Pain Rating Scale 0---10)
3. A minimum ODI score of 10/50 (i.e. 20% minimum on Oswestry Disability Index)

Exclusion Criteria:

1. Cauda Equina Syndrome
2. Neurologic presentation consistent with upper or lower motor neuron dysfunction due to spinal involvement (ie myelopathy or nerve compression, hyperreflexia, pathologic reflexes, depressed or absent reflexes in the lower extremities, motor weakness involving major muscle groups of lower extremity, unsteady gait, diminished or absent pin prick sensation in the legs and/or feet)
3. Spinal fractures
4. Currently pregnant
5. Co-existing medial problems / comorbidities (e.g., severe osteoporosis, tumors, inflammatory or infectious conditions, diabetes, angina, severe hypertension, RA, etc.)
6. Involvement in litigation of worker's compensation claim for low back
7. Physical therapy or chiropractic treatment for low back pain in the 3 months before initial examination
8. Any indication that might contraindicate spinal manipulative therapy.
9. Recent surgery to the lumbar or thoracic spine.
Behavioral Economic Interventions at Food Pantries

The investigators run a series of behavioral economic interventions at client-choice food pantries to encourage clients to choose targeted foods.

The study includes simple interventions at food pantries in New York State. In the initial phase, the investigators are testing the effect of order, packaging, pricing products, and relative proportion of products at a food pantry.

Eligibility Criteria:
Inclusion Criteria:

* Client in food pantry

Exclusion Criteria:

* Minors
Exercise Habits and Preferences of Community Dwelling Older Adults with Chronic Pain

Objective:

* To explore the exercise habits and preferences of community dwelling older adults with chronic pain
* To explore the facilitating factors and barriers in performing regular exercise for community dwelling older adults with chronic pain

Significance of study:

Chronic pain is a significant issue affecting both physical well-being and socioeconomic aspects across different age groups. Among older adults, physical inactivity is common, especially among those experiencing chronic pain. However, regular physical exercise offers numerous health benefits for the musculoskeletal, cardiovascular, and central nervous systems.

This project aims to explore the exercise habits and preferences of community-dwelling older adults with chronic pain. By identifying facilitating factors and barriers related to exercise, we can develop tailored exercise programs. These programs will promote healthier habits, allowing older adults to continue living independently in their communities and potentially delaying the need for long-term care facilities.


Eligibility Criteria:
Inclusion Criteria:

* Aged 60 or above
* Scored \&gt;6 in the Abbreviated Mental Test
* Can understand Cantonese
* Have a history of non-cancer pain in the past 6 months

Exclusion Criteria:

* Have a serious organic disease or malignant tumour
* Have a mental disorder diagnosed by neurologists or psychiatrists
* Have further medical/surgical treatment in two months or experienced drug addiction
Oral Nutritional Supplement in Reducing Surgical Site Infections

The study aims to evaluate the efficacy of an arginine enriched oral nutritional supplement in the prevention of wound complications in the the wounds of patients post lower limb revascularization.

Surgical incisions are associated with a number of possible complications. The reported incidence of surgical site infections at the groin after vascular procedures is between 3% and 30%. This incidence is up to five times higher than the expected incidence of infection in clean cases. Risk factors for postoperative surgical site infection in patients undergoing vascular surgery may include age, co-morbidities, use of prosthetic grafts and repeat operations.

A systematic review in 2011 concluded that arginine supplemented diets among perioperative patients were associated with a reduced rate of surgical infection and reduced overall length of hospital stay.

The study aims are to determine if taking an oral nutritional supplement reduces the rate of wound complications post lower limb revascularization.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective lower limb revascularization surgery
* patients aged \>18 years.

Exclusion Criteria:

* Patients unable to provide informed consent,
* emergency cases,
* seriously ill patients/unconscious patients,
* chronic renal disease,
* known inflammatory bowel disease,
* known lactose intolerance and not using lactase,
* known galactosemia,
* pregnancy,
* cows milk allergy.
Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia

Medically Assisted Reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. In the context of In Vitro Fertilization (IVF), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. Several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. The puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. None of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. General anesthesia is mostly chosen at Rennes, although it exposes to more risks and represents a higher socio-economic cost.

Improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. What if virtual reality could be a way to improve the comfort of these patients? Indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. In our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. The expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. The final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of Medically Assisted Reproduction of Rennes, but also in other cities. In the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use.

Observational, prospective, randomized, open-label, monocentric study.


Eligibility Criteria:
Inclusion Criteria:

* Female adult (at least 18 years old)
* For whom an oocyte retrieval is planned
* Who has had an anesthesia consultation
* Who has chosen local anesthesia
* Who has signed an informed and written consent
* Affiliated to a social security system.

Exclusion Criteria:

* Pre-existing dizzying sensations
* Severe facial wounds
* History of epilepsy
* Adults under legal protection, curatorship or guardianship, adults deprived of liberty
Effect of Prednisone and Aspirin on IVF-ET Outcome Among Patients With Thyroid Autoimmunity

This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.


Eligibility Criteria:
Inclusion Criteria:

1. TPOAb\>34IU/ml and/or TgAb\>115IU/ml
2. ≥5 follicles with average diameter lager than 14 mm at trigger day
3. ≥5 oocytes retrieved
4. for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage
5. age: 20-38 years old
6. Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.

meet item 1, 5, 6, and one of item 2, 3, 4.

Exclusion Criteria:

* hyperthyroidism
* intrauterine adhesion
* with endometrium thickness less than 6mm
* uterine malformation
* PGT
* with other autoimmune diseases need glucocorticoid or aspirin treatment
* gluacoma
* gastric ulcer