cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis

This study will be conducted to answer the research question:

Are there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis?

The purpose of this study is to compare the effects of biodex training balance versus whole body vibration training on Knee osteoarthritis on:

* Pain intensity
* static balance
* dynamic balance
* Functional ability level

Eligibility Criteria:
Inclusion criteria:

1. Subjects age between (40-60) years old.
2. Radiologic findings had to be compatible with knee OA grade 2 in a simple X ray.
3. Tenderness on medial tibial plateau
4. Intensity of pain: visual analogue scale equal to 5 or greater
5. Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) in the last three months

Exclusion Criteria:

1. Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
2. Subjects with diabetes mellitus.
3. acute symptomatic arthritis
4. other conditions (such as osteomyelitis, tuberculosis, and tumor) that affect their walking function; had a contraindication to exercise; and exhibited cognitive impairment
Epidural Technique: Does it Really Matter to the Patient?

The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

There are approximately 4 million child birth deliveries in US hospitals per year, and 1.3million of those births are via cesarean section (c-section). With this type of surgery, obstetric anesthesiology plays an important role. The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Eligibility Criteria:
Inclusion Criteria:

* Female parturient at Grady Memorial Hospital must meet one of the following:
* Parturient having a scheduled or elective cesarean section
* Parturient not having primary cesarean-section
* At least 18 years of age
* Subject has signed the informed consent

Exclusion Criteria:

* Parturient who is unable or unwilling to sign the consent form
* Parturient having primary cesarean section
* Parturient with known complex cardiac disease (ex...aortic/mitral stenosis, aortic aneurysms, congenital heart disease with residual defects...etc)
* Parturient with any contraindication to neuraxial anesthesia such as coagulopathy, infection, or patient refusal
* Parturient having a fourth or more cesarean section
Improving Ambulation Post Stroke With Robotic Training

The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Age\>18
* At least 3 months post stroke at time of enrollment into study
* Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently
* Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4
* Ability to perform Lokomat ambulation training with assistance of 1 therapist
* Ability to follow a three-step command
* Physician approval for patient participation
* Ability to give informed consent
* Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies

Exclusion Criteria:

* Serious cardiac condition
* Uncontrolled blood pressure, defined as \> 200 or diastolic \> 100 at rest
* Hx of serious chronic obstructive pulmonary disease or oxygen dependence
* Sever weight bearing pain
* Lower extremity amputation
* Claudication while walking
* Life expectancy \< 1 year
* History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months
* Severe orthopedic problem
* Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study
Research on Endoscopic Precision Biopsy.

Colorectal adenoma is a common disease and frequently-occurring disease in gastroenterology. With the continuous progress of colonoscopy equipment and the gradual improvement of endoscopic accessories, especially the development of chromo-endoscopy and magnifying endoscopy. The observation of the surface structure and capillary morphology of colorectal adenomas can realize optical biopsy. Currently, most clinical endoscopic diagnosis of colorectal diseases is biopsy under colonoscopy, and further treatment options are determined based on the pathological results of the biopsy. The problem is that the pathological diagnosis of some preoperative biopsy is not completely consistent with the pathological diagnosis of postoperative large specimens. Previous studies have found that the pathological diagnosis accuracy rate of preoperative biopsy is only 66-75%, so there is a certain degree of subjectivity in relying solely on colonoscopy white light biopsy. Based on the previous work, the research team has initially established an intelligent recognition model for colorectal adenoma classification (low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia), and formed a colorectal adenoma of a certain size with annotated endoscopic image data set. Using the YOLO-V4 algorithm, under the Darknet framework, to train an artificial intelligence (AI) system which specifically for adenoma recognition and diagnosis, its accuracy rate has reached more than 90%. This study intends to increase the sample size based on the previous work, and further improve the accuracy of the classification and diagnosis of the AI system, so as to guide the endoscopist to perform targeted biopsy and improve the accuracy of preoperative biopsy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 30-75;
* Those who have no mental abnormality and can conduct questionnaire surveys;
* BBPS ≥ 6;
* Colorectal advanced adenoma, and admitted for complete resection with EMR and ESD;
* Provide the relevant information required by this study and sign the informed consent.

Exclusion Criteria:

* Those who cannot provide the relevant information required by this research;
* Patients with inflammatory bowel disease;
* Those with a history of liver cirrhosis, uncontrolled hypertension, history of myocardial infarction, cardiac insufficiency, renal insufficiency, respiratory failure, diabetic ketosis and electrolyte imbalance and other serious diseases;
* Those who cannot stop antiplatelet drugs or anticoagulant drugs;
* Those who have not completed full colonoscopy;
* Pregnant women.
The Mochudi Prevention Project ART Protocol

The goal of the "Mochudi Prevention Project" is to reduce the number of new HIV infections in the village of Mochudi, Botswana by promoting a comprehensive package of interventions that have proven to be effective in preventing the spread of HIV. This antiretroviral treatment (ART) clinical study is nested within the Mochudi Prevention Project, and is being conducted in the north-east segment (NES) of the village of Mochudi. The ART intervention component of the Mochudi Project is designed to determine the uptake of, adherence to, and feasibility of 3-drug combination ART as a component of a package of transmission prevention strategies. The hypotheses are 1) that ART (with 3 antiretrovirals from two classes of drugs) among participants with CD4 ≥ 250 cells/mm3 and VL ≥ 50,000 cp/mL will be acceptable and safe and 2) Eighty percent of eligible participants will agree to start 3-drug ART.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection
* CD4 cell count ≥ 250 cells/mm3
* HIV-1 RNA ≥ 50,000 cp/mL
* No AIDS-defining illness or other illness that would cause volunteer to be eligible for ART through the Botswana National Program (these volunteers should be referred to the National Program for treatment)
* Age 16 to 64 years
* Botswana citizen
* Resident of the north-east segment of Mochudi
* The following laboratory values obtained within 60 days prior to study enrollment:

  * Absolute neutrophil count (ANC) ≥ 500 cells/mm3.
  * Hemoglobin ≥ 7.0 g/dL.
  * AST (SGOT), ALT (SGPT), and bilirubin ≤ 5 X ULN. Note: if the estimated creatinine clearance (by Cockgroft-Gault equation) is \<60 mL/min, then TDF/FTC will be substituted with ZDV/3TC
* Ability to swallow oral medications.
* Ability and willingness of participant to give informed consent (or in case of participants \< 18 years of age, ability and willingness to provide assent; and for parent/guardian to provide consent).
* Not currently involuntarily incarcerated.
* Karnofsky performance score ≥ 70 at time of study enrollment.
* If participating in sexual activity that could lead to pregnancy and of reproductive potential, female participants must use two reliable methods of contraception simultaneously, one of which must be a barrier method, while receiving protocol-specified medications, and for 12 weeks after stopping the medications.
* For participants \< 18 years of age: Weight of 40kg or more

Exclusion Criteria:

* Receipt at any time prior to study enrollment of \> 7 days cumulative treatment with any ARV or combination of ARVs (except ARVs taken for any length of time during pregnancy for the prevention of mother-to-child transmission (pMTCT) or ARVs taken for occupational exposure).
* Current receipt of 3-drug ART for pMTCT
* Allergy/sensitivity to any study drug or its formulations.
* Acute therapy for serious medical illnesses, in the opinion of the site investigator, within 14 days prior to enrollment.
Educational Video on Pain Management and Subsequent Opioid Use After Cesarean Delivery

This is a randomized controlled trial assessing the utility of an educational video on pain management after a cesarean section to reduce opioid use. The educational video will be shown during the patient's postpartum stay and the amount of opioid and adjunct medications will be assessed in those who watched the video compared to those who received the standard of care discharge instructions without the video. Participants will be contacted 7 and 14 days after cesarean birth (post operative day number 7 and number 14) to complete a telephone survey on their overall pain management and to determine how many opioid tablets have been used.


Eligibility Criteria:
Inclusion Criteria:

* Greater than 18 years of age
* Underwent repeat or primary C-section
* Literate in English Language

Exclusion Criteria:

* Complicated cesarean section including cesarean hysterectomy, bowel injury, bladder injury, and/or take-back
* History of opioid use disorder and/or on chronic opiates in pregnancy
* Contraindications to NSAIDS or acetaminophen
Management of Malnutrition in Oncogeriatrics

In France, undernutrition affects almost three million people, a third of whom are over 70 (Diagnosing undernutrition earlier in the elderly aged 70 and over, n.d.). In fact, 30 to 70% of hospitalized elderly patients suffer from protein-energy undernutrition (denutrition_personne_agee_2007_-_recommandations.pdf, n.d.).

The Nutricancer 2 study published in 2014, demonstrated that undernutrition is common among cancer patients. Indeed, 39% of patients suffer from undernutrition and its prevalence depends on the type of cancer, with a predominance of esophagus, stomach and pancreas (60% to 66%), colon/rectum, ovary/uterus and lung (39% to 45%), hematological malignancies (34%), as well as prostate and breast (13% to 20%) (Hébuterne et al., 2014). Moreover, over the past 30 years, undernutrition has been observed in 30% to 50% of the population at the time of diagnosis and before the start of cancer treatment (Boranian et al., n. d.).

Undernutrition is often associated with several terms such as malnutrition, anorexia, sarcopenia or cachexia, which refer to geriatric or metabolic syndromes of multifactorial origin that sometimes overlap, and are often observed in cancer patients. Cancer cachexia is a metabolic syndrome associated with undernutrition of multifactorial origin (Boranian et al., n.d.). Its prevalence is around 50% to 80% in cancer patients and is an independent indicator of morbidity and mortality in this population (Nicolini et al., 2013).

Undernutrition is a major health issue in elderly cancer patients. It is therefore crucial to diagnose it early, given its high prevalence in this population and the serious complications it can lead to. In 2021, the HAS updated its recommendations on the diagnosis of undernutrition in the elderly. The diagnosis of severe undernutrition is based on several criteria, including serum albumin levels. This is a commonly used marker of nutritional status, especially in patients with involuntary weight loss. However, it is important to note that hypoalbuminemia can be observed in many pathological conditions, including inflammatory syndromes common in cancer. Therefore, interpretation of albuminemia results must take into account the patient's inflammatory status, assessed by C-reactive protein. This analysis makes it possible to distinguish undernutrition due to insufficient food intake from that associated with an inflammatory syndrome and hypercatabolism (Patry \& Raynaud-Simon, 2010).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 70 and over with a diagnosis of moderate or severe undernutrition
* All patients with diagnosed cancer and ongoing cancer treatment.

Exclusion Criteria:

* Patients under 70 years of age
* Hospitalized patients no longer undergoing anticancer treatment
* All patients undergoing pre-habilitation for surgery
iHEART-SA Intervention Study

Using qualitative data during the formative phase the IHEART-SA research study filled deficiencies in knowledge regarding: 1) what barriers exist to integrating hypertension care within the HIV care setting in South Africa and, 2) how a hypertension care intervention can be adapted to effectively and sustainably function in this care setting. These data have been used to design a context-relevant intervention package for implementation in the next phase of effectiveness-implementation testing, answering the research question: How does an intervention aimed at enhancing hypertension diagnosis and management in people living with HIV improve the delivery of guideline-recommended care in primary healthcare clinics in Gauteng, South Africa, and hypertension control among patients?

The study will use an effectiveness-implementation study design. This design allows for the testing of strategies to promote integration of proven interventions in real-world practice (i.e., implementation strategies), while simultaneously assessing clinical effectiveness (i.e., patient level outcomes). For this the study will use a randomized cluster stepped-wedge study design where nine clinics (grouped in clusters of three) will be assigned to a time at which they initiate the intervention.

Investigational interventions:

Implementation facilitation of improved hypertension screening and management in the HIV care setting through the iHEART-SA intervention model comprising:

1. Information management system
2. Task shifting
3. Audit and feedback
4. Healthcare worker education and training
5. Patient education and support

Study design:

Cluster randomized stepped wedge effectiveness-implementation type 2 hybrid

Study objectives:

1. Assess the short- and long-term effects of an implementation strategy (i.e., healthcare worker intervention) on the adoption and implementation of hypertension screening and treatment among healthcare workers
2. Assess the short- and long-term effects of a clinical intervention (i.e., patient-level intervention) on patient blood pressure control among patients living with HIV and hypertension

Duration of participation: 27 months Study duration: 37 months

Intervention audience:

1. Healthcare workers (nurses and doctors)
2. Adult patients living with HIV from the 9 primary healthcare clinics

Eligibility Criteria:
Inclusion Criteria:

Healthcare workers:

1. Adult \>18 years men and women working in clinical roles at the selected clinics
2. Provide informed consent (only those participating in the qualitative components)

Patients:

1. Adults \>18 years living with HIV and hypertension
2. Enrolled in the study clinic
3. Willing and able to provide informed consent

Exclusion Criteria:

Patients:

1. Unable or unwilling to provide informed consent
2. Planning to relocate or change service providers/clinics
Reducing Elevated Heart Rate in Patients With Severe Sepsis by Ivabradine

REHSI is a prospective, multi-center, open label, randomized, controlled two arms, to evaluate the ability of ivabradine to reduce an elevated heart rate in septic shock patients. The primary end point is the reduction of heart rate within 24 hours. This trial will randomize 70 patients (men and women, aged ≥ 18 years) with newly diagnosed Septic Shock (despite adequate fluid resuscitation, were still requiring high-dose norepinephrine (NE) to maintain a mean arterial pressure (MAP) ≥65 mmHg , and had a tachycardia \>100 beats per minute (bpm). Treatment period will last 4 days. All patients will be followed for up to six months.


Eligibility Criteria:
Inclusion Criteria:

1. Severe sepsis due to coronary and non-coronary etiology
2. Severe sepsis diagnosed ≤ 24 h
3. Sinus rhythm with heart rate ≥ 100bpm
4. Written informed consent or identified or suspected positive will with respect to the trial treatment

Exclusion Criteria:

1. Patients who have not yet completed the 18th year of age
2. Pregnancy, lactation
3. Patients with a history of pre-existing chronic renal failure with a glomerular filtration rate \<30ml/min
4. severe hepatic insufficiency
5. Sick sinus syndrome
6. Sinu-atrial block
7. pacemaker-dependency 8.3rd degree AV block

9.Use of potent cytochrome P450 3A4 inhibitors such as antifungals of the azole -type (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see Summary of Product Characteristics (SPC))
The Efficacy and Safety of Early Rehabilitation in Large Vessel Occlusion Patients After Intra-arterial Thrombectomy: A Prospective Randomized Controlled Trial

Early rehabilitation is feasible for stroke patients is still under debate. In addition, IA thrombectomy has been a new treatment for the past few years and currently no known research exploring the efficacy of very early rehabilitation after thrombectomy, or any possible rehabilitation-related adverse effects. Therefore, in this study, the investigators will investigate the effectiveness of earlier rehabilitation intervention after IA thrombectomy for cerebral large vessel occlusion based on functional independence.

The study will be the prospective randomized controlled trial, where patients eligible for inclusion will be randomly assigned to earlier rehabilitation group or control group. The investigators will analyze the correlation between frequency/intensity of rehabilitation and primary/secondary outcomes. Dose-response analysis for earlier rehabilitation will be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Cerebral stroke due to infarction of large vessels in the anterior circulation, including internal carotid artery (, middle cerebral artery (MCA) M1 or M2 segment, anterior cerebral artery (ACA) A1 segment
2. Receive arterial thrombectomy (IA thrombectomy)
3. Stable vital signs include heartbeat less than 130 bpm, systolic blood pressure less than 180mmHg, blood oxygen SpO2 \>92%
4. No use of pressors, oxygen masks or respirators after arterial thrombectomy

Exclusion Criteria:

1. Posterior circulation large vessel stroke
2. Functional score (mRS) ≥ 3 points before the stroke
3. Other contraindications for rehabilitation treatment
4. Neurosurgery immediately after this stroke
5. Those who cannot receive rehabilitation within one week of stroke due to serious medical problems
6. After the stroke, two specialists judged the end of life and arranged palliative and palliative treatment
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer

This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).


Eligibility Criteria:
Inclusion Criteria:

* Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1
* Known hormone receptor status (estrogen receptor and progesterone receptor)
* The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
* Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
* Confirmed HER2 positive status
* Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
* Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug

Exclusion Criteria:

* History of any prior (ipsi- and/or contralateral) invasive breast cancer
* History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
* Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
* Any node-negative tumor
* Any previous systemic chemotherapy for cancer or radiotherapy for cancer
* Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
* Concurrent anti-cancer treatment in another investigational trial
* Serious cardiac or cardiovascular disease or condition
* Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
* Abnormal laboratory tests immediately prior to randomization
* Pregnant or lactating women
* Sensitivity to any of the study medications or any of the ingredients or excipients of these medications