cyrilzakka/clinical-trials huggingface dataset:
Utilizing EMG Shorts in Hip Population

The purpose of this study is to use a combination of electromyopathy (EMG) shorts and muscle monitoring software to collect data from participants performing physical exercises in order to determine the combination's diagnostic efficacy and ability to provide rehabilitative guidance for people who are recovering from hip injuries. Both healthy volunteers and Duke Patients seeking treatment for their hip pain and/or injuries will be enrolled in our research. If participants choose to take part they will be asked to wear these EMG shorts and perform various exercises like running on a treadmill, riding a stationary bike, or lifting weights.

Participation in this study consists of one study visit for healthy volunteers, but will last up to six months for Duke Patients. At each standard of care clinic visit throughout six months, Duke Patients will be asked to also come in for a study visit, wear the EMG shorts, and perform the same exercises preformed during the first study visit.


Eligibility Criteria:
Inclusion Criteria:

Inclusion (Duke Patients):

* All subjects must be 18 years of age or older.
* Any patient that currently has hip pain or injury and is seeking treatment from either Dr. Mather, Dr. Lewis, or Dr. Olson, within the hip preservation clinics.
* Subjects must be able to fit into the shorts in order to participate.

Inclusion (Healthy Volunteers):

* All healthy volunteer subjects must be 18 years of age or older.
* Subjects must be able to fit into the shorts in order to participate.

Exclusion Criteria:

Exclusion (Duke Patients):

* Any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery).
* Patient is unable to provide written consent, or patient is unable to speak, write, or understand English.
* Pregnant women (Verbal Confirmation)
* Allergic or hypersensitivity to laminate material.

Exclusion (Healthy Volunteers):

* Any recent lower extremity injury (such as an ankle sprain/surgery or knee surgery).
* Prior hip surgery, or current hip injury, surgery, or pain.
* Patient is unable to provide written consent, or patient is unable to speak, write, or understand English.
* Pregnant women (Verbal Confirmation)
* Allergic or hypersensitivity to laminate material.
Treatment of PD-1 Inhibitor in AIDS-associated PML

PD-1 inhibitor （Pembrolizumab, 2mg/kg weight, once per 4 weeks and 3 times of medication usage）treatment on AIDS patients with progressive multifocal leukoencephalopathy.

This is a one-center, single-arm and prospective study, planing recruiting 10 AIDS-associated PML patients. All patients will receive PD-1 inhibitor (Pembrolizumab) for 12 weeks, and the dose for each time is 2 mg per kg/weight, and the frequency is once per 4 weeks. The effect and safety of Pembrolizumab on AIDS-associated PML will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65
2. Diagnosed of HIV by lab confirmation
3. Diagnosed of PML by diplomatic radiologists through brain MRI or by brain biopsy once there are some concerns on radiologic diagnosis.
4. agree to sign the consent
5. agree to use contraception measures during 4 weeks before to 6 months after this study

Exclusion Criteria:

1. Pregnancy or lactating women or planing birth during this study
2. Anticipated bad treatment compliance
3. Within 6 months before joining this study, receive other immunosuppressors, immunomodulators or cytotoxic drugs (glucocorticoid is allowed)；
4. With neutrophil\<1000/mm3 or platelet\<75000/mm3 or allergic to PD-1 inhibitor 5）With severe basic diseases in heart, brain, lung, liver, kidney

6) disagree to sign the consent
Investigation of GLP1-Receptor Agonists in Men With Prostate Cancer Taking Androgen Deprivation Therapy

GAIN PC CONTROL is a study investigating Glucagon-Like Peptide-1 Receptor Agonists in men with prostate cancer who are being treated with androgen deprivation therapy.

GAIN PC CONTROL is an open-label single-arm phase IV trial that will evaluate 1) the safety and tolerability of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) in men with prostate cancer (PC) treated with androgen deprivation therapy (ADT); 2) the effects of GLP-1 RAs on weight, waist circumference, blood pressure, HbA1c, lipids, PSA and Creatinine, estimated glomerular filtration rate in men with PC treated with ADT.

Patients who meet eligibility criteria and who provide informed consent will be enrolled to receive semaglutide.

Following enrollment, all participants will undergo a baseline visit, a 1-month telephone follow-up visit, 3-month visit and 6-month (Close-out) visit.

The semaglutide dose will be 0.25mg subcutaneously once weekly for weeks 1-4, then 0.5mg once weekly for weeks 5-8, then 1mg once weekly for weeks 9-12, then 1.7mg once weekly for weeks 13-16, and then 2.4mg for the remainder of the trial. Semaglutide dose may be decreased in the case of adverse events to the highest tolerated dose.

Eligibility Criteria:
Inclusion Criteria:

* Have a physician diagnosis of PC
* Must be receiving or planned to receive ADT (gonadotropin releasing hormone agonist or antagonist ± androgen receptor pathway inhibitor)
* Elevated BMI

  1. ≥30kg/m2 or
  2. ≥27kg/m2 in the presence of at least one of hypertension, type 2 diabetes, obstructive sleep apnea or dyslipidemia

Exclusion Criteria:

* Type 1 diabetes
* Taking a GLP-1 RA
* \<18 years of age
* History of pancreatitis
* Personal or family history of medullary cancer of the thyroid
* Multiple endocrine neoplasia type 2
Evaluation of ACT Now GAIN Later

The goal of this Randomised Control Trial is to evaluate a Psychologist Guided Self Help Video Parenting Programme based on principles of Acceptance and Commitment Therapy (ACT)

The main questions it aims to answer are:

Primary Objectives

1. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in increasing parental psychological flexibility (measured by Psy-Flex, tool which measures psychological flexibility)? Please find attached.
2. Is ACT Now GAIN Later: a Psychologist Guided Self Help Video Parenting Programme based on principles of ACT effective in decreasing child challenging behaviour (measured by the Eyberg Child Behavior Inventory)? Please find attached.

Secondary Objectives

1. Is ACT Now GAIN Later: an ACT based Parenting Programme, effective in improving parent-child relationships (measured by the Child-Parent Relationship Scale)? Please find attached.
2. Does ACT Now GAIN Later increase parental well-being as measured by (Depression Anxiety Stress Scale, Parenting Stress Index and Goal Based Outcome Tool)? Please find attached.
3. Does ACT Now GAIN Later increase parental self-efficacy (TOPSE and Parental Sense of Competence scale)? Please find attached.

Participants will complete a 7 week psychologist guided parenting intervention. Researchers will compare waitlist groups to see if there are differences in psychological flexibility, child behaviour, parent-child relationships, parental well-being or parental self-efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Parents of children from the ages of 3-12 will be included in this study.
* Parents of children with challenging behavior.

Exclusion Criteria:

* Parents of children outside of the age range 3-12 years old
* Parents of children who do not have challenging behavior
Comparison of the Cuff Pressure Between a Taper-guard Cuffed Tube and a Cylindrical-shaped Cuffed Tube

Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/oxygen and remifentanil. The cuff pressure was initially set at 22 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. The change of cuff pressure was compared between two groups

Endotracheal pressure with different cuff shapes can result in different cuff pressure change after head positional change. In this study, 52 patients underwent middle ear surgery with general anesthesia were randomly allocated to two group; patients were intubated with taper guard cuffed tube or cylindrical shaped cuffed tube. Anesthesia was maintained with sevoflurane with air/O2 and remifentanil. The cuff pressure was initially set at 24 centimeters of water in the neural head position and was measured after the change to the 45 degree head rotation. In addition, sore throat, hoarseness , dysphagia and cough were recorded 0, 6, 12, 24 hr after surgery. The change of cuff pressure was compared between two groups. The side effects associated with tube were compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent middle ear surgery with general anesthesia American Society of Anesthesiology status 1-3

Exclusion Criteria:

* Patient with neck pain Patient with a history of neck surgery Patient with limited movement of neck Patient with body mass index more than 35
Weight Loss and Exercise To Improve Rheumatoid Arthritis Cardiovascular Risk

This is a small exploratory, randomized, controlled trial. Twenty-six older (ages 60-80 yr.), obese (BMI 28-40 kg/m2) persons with rheumatoid arthritis (RA) (seropositive or erosive) will be randomized to 16 weeks of a counseling health as treatment (CHAT) program or a supervised weight loss and exercise training (SWET) program.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 28-40 kg/m2.
* Must have internet access.
* Seropositive (positive rheumatoid factor or anti-citrullinated protein antibody) or erosions typical of RA on radiographs.

Exclusion Criteria:

* Subject unwilling/unable to utilize online platforms (e.g. ZOOM, REDCap, Pattern Health) for study activities.
* Current use of biologic agents other than those targeting tumor necrosis factor alpha.
* Current (within the last month) pharmacologic therapy with corticosteroids at doses greater than prednisone 5mg per day (or equivalent glucocorticoid doses).
* Participating in regular exercise within the past 3 months (According to 2018 US guidelines: Not more than 150 minutes per week of moderate intensity exercise or 75 minutes per week of vigorous intensity exercise).
* New medications within the last three months and stable doses for ≥ 1 month.
* Diagnosis of coronary artery disease.
* Diagnosis of type 2 diabetes mellitus.
* Other inflammatory arthropathy or myopathy, Paget's disease, pigmented villonodular synovitis, joint infection, ochronosis, neuropathic arthropathy, osteochondromatosis, acromegaly, hemochromatosis, or Wilson's disease.
* Absolute contra-indications to exercise: Recent (\<6 months) acute cardiac event, unstable angina, uncontrolled dysrhythmias causing symptoms or hemodynamic compromise, symptomatic aortic stenosis, uncontrolled symptomatic heart failure, acute pulmonary embolus, acute myocarditis or pericarditis, suspected or known dissecting aneurism or acute systemic infection.
* Relative contra-indications to exercise: Left main coronary stenosis, moderate stenotic valvular heart disease, outflow tract obstruction, high degree AV block, ventricular aneurysm, uncontrolled metabolic disease (e.g. diabetes, thyrotoxicosis, myxedema), uncontrolled pulmonary disease (e.g. severe COPD or pulmonary fibrosis), mental or physical impairment leading to inability to exercise adequately.
* Significant weight change (gain or loss of \> 10 pounds in 1 month) within the past 6 months.
* Unwillingness or inability to adhere to the diet structure of the study.
Understanding Adoption for Clean Cookstoves: A Demand Study

The aim of the Adoption study is to determine how best to encourage people to adopt clean cookstoves in order to diminish the global health risk of household air pollution. The study harnesses an existing cohort in Ghana to study factors that increase the adoption of clean cookstoves, and to test strategies to promote adoption and continued use. Limited past research has shown that the demand for clean cookstoves is low, and that households continue to use traditional hearths even when they have clean cookstoves. This behavior threatens to undermine clean cookstove intervention programs, such as those promoted by the Global Alliance for Clean Cookstoves. The proposed study aims to ascertain the demand curve for liquified petroleum gas (LPG) in the Kintampo North Municipality and South district.

The study will assess if demand for LPG in rural settings in Ghana is price elastic - and by how much - by providing different levels of LPG price subsidies. It will also ascertain if demand is influenced by distance by allocating participants to varying distances to points of LPG supply. Finally, it will assess factors that could affect the demand for LPG such as availability and price of other fuels for cooking, and income levels.

In particular the objectives of the study are:

1. To determine if demand for LPG is price elastic
2. To determine if demand for LPG is influenced by distance
3. To ascertain what other factors aside the price of LPG, and distance to point of LPG supply, determine the demand for LPG
4. To document the successes and challenges of introducing a subsidy for LPG in rural settings

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Primary cook of the household
* Part of the Ghana Randomized Air Pollution and Health Study (GRAPHS) sample or reside in a sample village
* Owns an LPG stove and cylinder (provided by the project in the case of newly recruited households)

Exclusion Criteria

- Temporarily residing in study area.
In Vitro And Ex Vivo Anti-Inflammatory Activities Of Salmon Polar Lipids

The aim of this project is to study the effects of a new-developed food-supplement that contains bioactive polar lipids derived from organic farmed Irish salmon for the beneficial promotion of cardiovascular health. The health claims that will be formulated for this nutraceutical are based on EFSA guidelines "The scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health" and in particular paragraph 5.4, "Claims on reduced platelet aggregation" "Platelet hyperactivity and hypercoagulability states are more commonly observed in subjects with cardiovascular (CV) risk factors. Healthy subjects at very low risk of CV disease normally have non-activated circulating platelets. Decreasing platelet aggregation in subjects with platelet activation during sustained exposure to the food/constituent (e.g. four weeks) would be a beneficial physiological effect".

Within this study, the postprandial effects of this novel food supplement against platelet aggregation and inflammation are going to be exploited ex vivo in blood from human subjects as described in previously established procedures.


Eligibility Criteria:
Inclusion Criteria:

Subjects need to:

* Have their dietary intake of fish to be within normal range (1-2 portions per week).

Exclusion Criteria:

Subjects will be excluded if they:

* Are currently taking medication and/or dietary supplements
* Have blood clotting disorders or dislipidemia
An Observational Study of Dual and Triple Therapies Based on Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C

This multi-center, observational study will evaluate the efficacy and safety of dual and triple therapies based on Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients receiving treatment with either Pegasys plus ribavirin or Pegasys plus ribavirin plus telaprevir/boceprevir will be observed for the duration of their treatment and for up to 24 weeks of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C (all genotypes, naïve or treatment experienced, HCV mono-infected or HCV-HIV co-infected)
* Receiving either dual therapy (Pegasys plus ribavirin) or triple therapy (Pegasys plus ribavirin plus telaprevir/boceprevir)
* No contra-indications to Pegasys and ribavirin therapy or to treatment regimen containing protease inhibitor (telaprevir or boceprevir) as detailed in local Prescribing Information
* Quantitative serum HCV RNA by PCR test before initiation of treatment

Exclusion Criteria:

* Hepatitis A/B co-infection
* Evidence of severe illness, active malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
* Pregnant or breast-feeding women
Research on the Development and Clinical Evaluation of Biomimetic Abutments

This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.

The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.

To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.

Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.

Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.

Eligibility Criteria:
Inclusion Criteria:

* aged between 25 and 65 years old
* had one single edentulous site
* implant embedded healed and required secondary surgery to expose
* good treatment compliance and could attend follow-up appointment regularly

Exclusion Criteria:

* soft tissue grafting was needed
* severe acute or chronic periodontitis
* heavy smoking habit (\> 10 cigarettes/day)
* poor oral hygiene
A Safety Study of Dapivirine (TMC120) Vaginal Microbicide Gel in Belgium

Approximately 36 HIV-negative women, aged \>18 and \< 50, will be enrolled in this study. Each volunteer will have a 2:1 chance of receiving dapivirine gel versus placebo. The volunteers will receive investigational product for a total of 42 days.


Eligibility Criteria:
Inclusion Criteria:

* HIV-negative
* Willing to participate and sign an informed consent form
* Willing to be tested for HIV, use an experimental vaginal gel, and to be randomized to a study group that includes the possibility of being assigned to a placebo group.
* Willing to use two forms of contraception during the study
* Willing to undergo pelvic examinations with colposcopy and photographic documentation according to the protocol throughout the study.
* Have a regular menstrual cycle defined as having a minimum of 21 days and a maximum of 36 days between menses

Exclusion Criteria:

* Currently pregnant or breast-feeding
* Clinically detectable genital abnormality on the vulva, vaginal walls or cervix
* Laboratory confirmed gonorrhea, chlamydia, trichomonas, syphilis, or vaginal candidiasis or clinically diagnosed GUD or active HSV-2 lesion
* Breakthrough bleeding or gynecologic surgery within 60 days prior to randomization
* Symptomatic bacterial vaginosis at Screening and unwilling to undergo treatment.
* Women who require treatment for tuberculosis (TB) within 21 days prior to randomization.
Dexamethasone Implant for Retinal Detachment in Uveal Melanoma

This is an investigator-initiated Phase I study of a single dose of an intravitreally-administered dexamethasone implant (Ozurdex™) in subjects with uveal melanomas (UM) and exudative retinal detachments (ERD: build-up of fluid under the retina that causes it to detach) being treated with proton beam radiation (PBI) or plaque radiotherapy. Although PBI is an effective treatment for UM, ERDs may persist after radiation, leading to vision loss. Effective treatments for ERD are currently lacking. We are conducting this study to evaluate whether Ozurdex™ can help resolve ERDs that occur in patients with UM. Ozurdex™ has been approved by the Food and Drug Administration (FDA) to treat certain ocular conditions such as macular edema, non-infectious uveitis, and diabetic macular edema but it is not approved for use in patients with UM and ERD. This study will determine the safety of the dexamethasone implant and provide preliminary evidence of efficacy in this population.


Eligibility Criteria:
Inclusion Criteria:

* Tumor thickness \<= 10 mm.
* Associated serous retinal detachment extending beyond tumor, \> two clockhours in extent.
* Primary treatment of ocular melanoma with proton irradiation or plaque radiotherapy.

Exclusion Criteria:

* Any pre-existing glaucoma.
* History of elevated IOP (\> 25 mm Hg).
* History of steroid response glaucoma.
* Active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva: active ocular herpes simplex, active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
* Any history of ocular herpes simplex.
* Torn or ruptured posterior lens capsule.
* Known hypersensitivity to any components of the dexamethasone intravitreal implant.
* Women of child-bearing potential: pregnant or planning to become pregnant.
Study Comparing SBS and LRTI for Treatment of CMC Arthritis

A multi-center, randomized control trial comparing the two standard of care surgical treatments for CMC arthritis ; trapezial excision with or without soft tissue interposition and /or ligament reconstruction (LRTI) versus the suture button suspension arthroplasty (SBS). Patient reported outcomes will be collected at 6 and 6 weeks, 3, 6, and 12 months.

LRTI is a well established treatment of CMC arthritis with good results.However, comparable results have also been reported with SBS, with the latter procedure eliminating the need for flexor carpi radialis (FCR) harvest and interposition, resulting in potential shorter OR time and donor site morbidity. To date, there have been biomechanical studies comparing LRTI vs suture button suspension arthroplasty (SBS), and clinical studies comparing trapeziectomy alone vs SBS, but to the best of our knowledge, no random control studies comparing LRTI with SBS.The primary objective is to determine whether treatment with SBS results in improved overall pain relief compared to LRTI as measured by patient reported outcomes.Secondary outcome measures will be to determine if SBS results in shorter OR time and improved grip and pinch strength compared to LRTI, as well as have comparable return to work times and amount of radiographic shortening as shown on radiographs (metacarpal shortening has been felt to lead to decreased grip strength).

Eligibility Criteria:
Inclusion Criteria:

* Age fifty years or older
* Isolated carpometacarpal (trapeziometacarpal) osteoarthritis
* Failure to respond to non-operative management
* Willing and able to consent on their own behalf and follow the protocol and clinical visits as described
* Able to read and understand English or have interpreter available

Exclusion Criteria:

* Previous surgery for CMC arthritis
* Duration of symptoms for less than 6 months
* Greater than or equal to 30 degrees of ipsilateral metacarpophalangeal (MCP) hyperextension
* Scaphotrapeziotrapezoidal (stage 4 CMC) arthritis
* Other significant ipsilateral wrist or hand pathology
* A history of inflammatory arthropathy
* A requirement for concomitant surgery for another condition
* Any previous hand or wrist fracture
* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged patients without adequate support, etc.)