cyrilzakka/clinical-trials huggingface dataset:
Wound Closure After Total Knee Replacement

To compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.

.Informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (Arm 1: will undergo wound closure with staples and Arm 2 wound closure with subcuticular prolene suture).

before the start of surgery. The primary investigator will open the sealed envelopes provided by the Indus Hospital Research Center's Clinical Research Unit (CRU) that provides the study arm allocation. The envelopes will follow the SNOSE protocol i.e. they will be sequentially numbered, opaque sealed envelopes. Before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. The envelope will contain carbon paper which will transfer the data allocation paper inside.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on X-rays and history)
* Bilateral knee surgeries
* Patients giving informed consent

Exclusion Criteria:

* Patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history)
* Patients taking steroids (confirmed by history)
* Body mass index \> 30 (increases chances of wound dehiscence)
* Lack of consent
* Pregnant females (confirmed by history)
Efficacy of CHX Cloths Versus CHX Soaps for Bathes Before Orthopedic Surgery

Surgical site infections (SSI) in orthopedic surgery are rare events but associated with great morbidity as well as a significant additional cost. The World Health Organization (WHO) recently carried out meta-analyzes on all the existing prophylactic measures and could not rule on the use of chlorhexidine (CHX) cloths due to the low number of studies available. CHX cloths could actually benefit patients for whom preoperative showering is not possible, whether in emergency or trauma settings due to pain-induced functional impotence. A randomized controlled clinical study aimed at evaluating the in vivo microbiological efficacy of CHX cloths in a population of orthopedic surgery patients while evaluating the psycho-social determinants of adherence to a new preoperative preparation technique seems essential.


Eligibility Criteria:
Inclusion Criteria:

* adult patients,
* undergoing orthopedic surgery: programmed hip prosthesis (non-urgent),
* admitted the day before the operation
* and having given their written consent.

Exclusion Criteria:

* presence of a documented infection at the time of the intervention,
* presence of skin wounds,
* presence of antibiotic treatment within 15 days before the operation
* intolerance to CHX,
Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects

Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been associated with persistent central nervous system symptoms or mild or even asymptomatic neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric adverse events during EFV has not been explored yet.

The proposed pilot study will examine whether switching from single tablet regimen TDF/FTC/EFV to single tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement among HIV-infected patients with mild/asymptomatic neurocognitive impairment or neuropsychiatric symptoms during EFV-containing antiretroviral treatment.

Patients under stable treatment with TDF/FTC/EFV, confirmed HIV-1 RNA viral load \< 50 copies/mL and altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or more domains as assessed by neuropsychological assessment, will be randomized to immediate or deferred (24 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be repeated after 12, 24 and 48 weeks of follow-up and variations will be compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old and ability to sign informed consent
* Continuative treatment with TDF/FTC/EFV for ≥180 days
* HIV-1 RNA viral load \< 50 copies/mL in two consecutive determinations (including screening)
* No history of treatment failure and/or evidence of any mutations associated with resistance to NRTI or NNRTI
* No contraindication to treatment with study drugs
* Any one of the following conditions:

  (i) Altered scores in depression, quality of sleep or anxiety tests (ii) Alteration in 1 or more domains as assessed by neuropsychological assessment

Exclusion Criteria:

* Ongoing treatment or predictable need of treatment with proton pump inhibitors
* New AIDS defining condition diagnosed within the 21 days prior to screening
* Previous diagnosis of AIDS dementia complex
* Current alcohol or substance dependence
* Major psychiatric disorders
* Decompensated cirrhosis
* Plasma creatinine \>1.2 mg/dl or estimated glomerular filtration rate \<60 ml/min (MDRD formula)
* AST, ALT or plasma bilirubin \>3 times upper limit of normal
* Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing/food requirements
Tumor Hypoxia and Proliferation in Patients With High-Grade Glioma

This is a pilot study to assess a new methodology developed for High Grade Glioma (HGG). FMISO PET (Fluoromisonidazole-PET) allows researchers to study whether tumor cells lack oxygen (hypoxia). FLT PET (Fluorodeoxythymidine-PET) allows researchers to study the increase in the number of cells as a result of cell growth and cell division (proliferation). Tumors that have low oxygen levels and/or are dividing fast shall resist to standard cancer treatment. The study will compare FMISO PET and FLT PET imaging techniques with molecular biomarkers of hypoxia, angiogenesis, and cellular proliferation in tissue. proliferation).This information could help researchers develop new treatment techniques to better treat cancer.

This is a pilot study to assess a novel methodology recently developed to simultaneously image tumor hypoxia and proliferation by means of simultaneous FMISO and FLT PET acquisition. FMISO (18F-Fluoromisonidazole) PET is a non-invasive method for detecting tumor hypoxia in solid tumors. FLT (3'-deoxy-3'\[(18)F\]-fluorothymidine) PET is a non-invasive method to image Cell proliferation rate. Imaging of tumor hypoxia and proliferation with FMISO and FLT PET respectively are two very well established techniques in in high-grade glioma. The long-term goal of this proposal is to establish clinically robust methodology to simultaneously image multiple tumor hallmarks. The central hypothesis is that combined information from multiple tumor hallmarks will offer complementary information about the underlying physiological processes, and will yield synergistic prognostic and predictive values. The rationale is that these findings will enhance the understanding of the underlying biology and pathophysiology, and will open new therapeutic strategies to target radioresistant and highly aggressive regions within the tumor, as well as aiding in the development of imaging theragnostics. The method used in this proposal is based on our previous work on simultaneous imaging of FMISO/FLT PET, and is facilitated by prior knowledge of the tissue pharmacokinetics, and an ability to distinguish the two radiotracers fractions in blood by thin-layer chromatography (TLC). The study will compare FMISO and FLT imaging findings with those from molecular biomarkers of hypoxia, angiogenesis, and cellular proliferation in tissue.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Documentation of a suspected HGG diagnosis based on clinical and MRI findings

Exclusion Criteria:

* Pregnant or breastfeeding
* Contraindications to receiving Positron Emission Tomography (PET) imaging (e.g. claustrophobia)
Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

AD:

* Male or female \>= 50 years of age
* Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
* Have a caregiver who can report on their mental status and activities of daily living (ADL)
* Give informed consent or have a caregiver give consent with subject assent.

FTD:

* Male or female \>= 45 years of age
* Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
* Give informed consent or have a caregiver give consent with subject assent.

CN:

* Male or female \>= 45 years of age
* Have and MMSE \>= 29
* Give informed consent

Exclusion Criteria:

* Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
* Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
* Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
* Have a recent history of alcohol or substance abuse or dependence
* Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
* Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
* Have ever participated in a study with an amyloid targeting agent
* Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol
Atomoxetine for Treatment of Weight Gain in Olanzapine or Clozapine Patients

The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.

The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia or schizoaffective Disorder
* Taking olanzapine or clozapine for at least 6 months
* Weight gain of 7% over baseline or BMI greater than or equal to 27

Exclusion Criteria:

* Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine
* Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months
* Current treatment with other medications for weight loss unless weight stable for 6 months
* Mental Retardation
* Alcohol or Substance Dependence within the last 6 months
* Pregnancy
* Alcohol or Substance Abuse within the lat month
* Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment
A Study of Evacetrapib (LY2484595) in Participants With High Cholesterol

The purpose of the ACCENTUATE study is to evaluate whether the study drug known as evacetrapib is effective in treating participants with high cholesterol and atherosclerotic cardiovascular disease (ASCVD) and/or diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Must be treated with atorvastatin 40 mg/day for at least 30 days prior to screening
* Have an LDL-C \>70 mg/deciliter(dL) or non-HDL-C \>100 mg/dL
* Have screening triglycerides ≤400 mg/dL (≤4.5 millimoles/Liter)
* Individuals with ASCVD and/or individuals with type 1 or type 2 diabetes

Exclusion Criteria:

* Have a hemoglobin A1c (HbA1c) \>9.5%
* New York Heart Association (NYHA) class III or IV congestive heart failure
* History of either a transient ischemic stroke or ischemic stroke \<30 days
* History of acute coronary syndrome (ACS) \<30 days
Bone Health in Patients With Overgrowth

The goal of this study is to determine whether or not patients with overgrowth syndromes have decreased bone density.

It is known that patients with complex vascular malformation are at risk of decreased bone density and even vanishing bone disease. However, what is not known is if patients with OGS are at decreased bone density at locations that are distant from the vascular malformation.

This study will look at bone health in patient's with OGS in a cross sectional fashion. If they are found to be at a particular risk for decreased bone density then this can be addressed in early childhood, through nutrition and activity recommendations.

The study will consist of 15 participants, all who have a known clinical diagnosis of an overgrowth syndrome, and will be \>5 years old so that they can co operate with a DEXA or Xtreme CT scan.

Study specifics:

* They will be asked specific questions regarding medical and family history and an intake form will be filled out.
* The height, weight, body mass index and Tanner stage measurements will be recorded during this visit.
* Photos of the affected area(s) will be taken, however, this is optional.
* A urine pregnancy test will be done in all females of childbearing potential .
* Laboratory studies will be performed in all patients.
* A 24-hour urine sample will be collected from adults who are able and willing; in children and in those not able or unwilling to provide a 24-hour urine, a spot urine will be collected.
* Bone age will be assessed via plain film of the wrist
* Bone density will be assessed for each patient via DEXA scan
* Cortical and trabecular parameters and bone strength will be assessed by HRpQCT

Eligibility Criteria:
Inclusion Criteria:

* Age \> 5 years such that the patient is able to cooperate with the DXA scan or Xtreme CT
* Known clinical diagnosis of an overgrowth syndrome such as Klippel-Trenaunay Syndrome, CLOVE syndrome, Proteus syndrome, diffuse capillary malformation with overgrowth, or other unspecified OGS.

Exclusion Criteria:

* Age \< 5 years
* Inability to comply with the scan
* No or uncertain diagnosis of an OGS.
* Prior bisphosphonate use
* Systemic steroids in the past 6 months
* Pregnant women
Comparison of Two NN1250 Formulations in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacodynamic properties (effect) by comparing two NN1250 (insulin degludec, IDeg) formulations in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors

The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.

The goal of this study is to characterize the feasibility, safety, and clinical activity of PSCA-specific CAR-T cells, BPX-601, administered with rimiducid to subjects with previously treated, PSCA-positive advanced solid tumors (prostate). BPX-601 CAR-T cells are genetically engineered to express a chimeric antigen receptor (CAR) to target the PSCA antigen and a rimiducid-inducible signaling domain which functions as a molecular "go-switch" to enhance activation and proliferation.

Phase 1: Cell dose escalation to identify the maximum dose of BPX-601 administered with single or repeat doses of rimiducid.

Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-601 persistence), and clinical activity at the recommended dose identified in Phase 1 in various PSCA-expressing solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
* Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA.
* Age ≥18 years.
* Life expectancy \> 12 weeks.
* ECOG 0-1
* Adequate organ function.

Exclusion Criteria:

* Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of \> Grade 2 hematuria within the previous 6 months.
* Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable.
* Symptomatic, untreated, or actively progressing central nervous system metastases.
* Impaired cardiac function or clinically significant cardiac disease.
* Pregnant or breastfeeding.
* Participant requires chronic, systemic steroid therapy.
* Severe intercurrent infection.
* Known HIV positivity.
The Analgesic Efficacy of the Pectoral Nerves Block Versus Local Anesthetic Infiltration After Mastectomy

This trial will include patients undergoing radical mastectomy under general anesthesia. One group of patients will receive a pectoral nerve block, done by the anesthetist under ultrasound guidance at the beginning of the invervention. The other group will receive the a wound infiltration at the end of the intervention, done by the surgeon. Investigators will compare acute pain-related outcomes and chronic pain at 3 and 6 months postoperatively.

Mastectomies are associated with moderate to severe postoperative pain. In addition to general anesthesia, different methods of locoregional anesthesia exist to treat postoperative pain, amongst others a pectoral nerve block. This block consists in injecting local anesthetic between the muscles of the thoracic wall and is done under ultrasound guidance. Over the last few years, the pectoral nerves block has become a recognized option for the treatment of acute post-mastectomy pain and it is routinely performed in addition to general anesthesia.

Data indicates that pectoral nerve blocks are effective for the treatment of postoperative pain during the first 24 hours after mastectomy, when compared to no block. However, the analgesic efficacy of a pectoral nerve block has never systematically compared to that of wound infiltration with local anesthetics, done by the surgeon at the end of the intervention. Such an infiltration is also currently employed.

In our study randomize patients undergoing mastectomy under general anesthesia will be randomized to receive either an ultrasound-guided pectoral nerve block with 30 mL of local anesthetic (group PECS) or a wound infiltration with 30 mL of local anesthetic (group infiltration).

Investigators will assess different pain-related outcomes over the first 24 postoperative hours, together with potential block-related side effects and patient satisfaction. Chronic postoperative pain at 3 and 6 months postoperatively will also be assessed.

Both patients and outcome assessors will be blinded to group allocation.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral mastectomy
* American Society of Anesthesiology Physical Status I-III
* Age ≥ 18

Exclusion Criteria:

* Contraindications to regional anesthesia, such as infection at the surgical site
* Pregnancy
* History of alcohol or drug dependence/abuse
* History of long term opioid intake
* Chronic pain disorder