cyrilzakka/clinical-trials huggingface dataset:
A Study of the Sense of Smell in Relatives of Parkinson's Disease Patients

In this study, individuals complete and return a mail survey, specifically a 40 item scratch and sniff smell test.

This study would extend the findings of previous studies by characterizing the performance of the 40-item UPSIT in a cohort of first-degree relatives of Parkinson's disease (PD) patients. The results would also validate the use of the University of Pennsylvania Smell Identification Test (UPSIT) as a mail-survey instrument. Once identified, these individuals could be followed as a potentially at-risk cohort to determine if the screening evaluation was predictive of later developing Parkinson's disease. The results from this pilot study have the potential to guide the use of olfactory testing using the UPSIT as a screening tool, and to provide necessary preliminary data for planning clinical trials to prevent the occurrence of PD in at-risk individuals.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a first-degree relative of a PD patient with diagnosis confirmed by a movement disorders specialist at the Institute for Neurodegenerative Disorders
* Subject must not carry a diagnosis of PD or other neurodegenerative disorder
* Subject must be either at least 50 years old or within 10 years of the age of onset of their affected relative
* Subject must be a non-smoker
* Subject must have no other known reason for abnormal olfaction (e.g. nasal trauma)
Effects of Protein on Muscle, Gut Microbiota and Clinical Outcome in Patients With Lung Cancer-related Sarcopenia

Sarcopenia is common in lung cancer patients. It is one of the significant factors affecting the overall survival, radiotherapy and chemotherapy efficacy, and quality of life of patients with lung cancer. Previous studies have shown that increased protein intake can stimulate postprandial muscle synthesis, and improve muscle mass, strength, function, and overall survival. However, most previous studies have focused on the intervention of whey protein, while the protective effect of soybean protein on lung cancer-related sarcopenia (LCRS) has not yet been fully explored and reached an agreement.

So, this study aims to explore the effects of soy and whey protein on muscle, gut microbiota, and clinical outcomes among patients with lung cancer-related sarcopenia, to provide a reference for further nutrition treatment.

This study will last 6 months. For the duration of the study, an anticipated total of 90 participants will be randomly assigned to receive either a 30-gram protein supplement or a placebo daily. There will be a total of 5 study visits, and dietary records, questionnaires, blood and stool collection, and functional testing will occur at all study visits. Intention-to-treat analysis (ITT) and per-protocol analysis (PP) will be conducted in statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* age\>=18years old
* Patients with lung cancer and sarcopenia
* ECOG\<=2
* Patients are able to provide written informed consent.

Exclusion Criteria:

* People who are allergic to soy protein and whey protein.
* Participants received any drugs or supplements known to influence effcet size, such as protein powder, anabolic steroids, or glucorticosteroid before the 3 months preceding the study.
* Participants with gastrointestinal bleeding, enterotomy or gastric bypass surgery before the 3 months preceding the study.
* Concurrent severe cardiac disease, liver and renal failure, which may significantly interfere with study compliance.
* Participants with electronic or mental device.
Feasibility Study of Metronomic Chemotherapy for Locally Advanced HER2-Negative Breast Cancer

The purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (G-CSF) is feasible in the treatment of locally advanced HER2-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced breast cancer diagnosed by guided core biopsy
* T \> 2 cm (any N), or any T and node positive (needle biopsy is required)
* Non-metastatic disease assessed by computed tomography and bone scintigraphy
* Histological grade 2 and Ki67 \> 15% or
* Histological grade 3 or
* Any triple negative (TN) or
* Inflammatory breast cancer (IBC)
* Normal left ventricular ejection fraction (LVEF)
* HER2-negative disease

Exclusion Criteria:

* Another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast)
* Clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (COPD), renal or liver failure, psychiatric disorders
* LVEF value below institutional limits of normal
* Predominant lobular carcinoma histology
* Grade 1 tumors
* Detected or suspicious distant metastasis
* Neutrophils less than 1,500/µL, platelets less than 100,000/µL, hemoglobin less than 10 g/dL, AST more than 2.5x upper limit of normal (ULN), total bilirubin more than ULN, alkaline phosphatase more than 1.5x ULN
* Male sex
* HER2-positive breast cancer
Class iv Versus Class Iiib Laser Therapy on Median Sternotomy Healing After Coronary Artery Bybass Graft

LASER therapy is potent physiotherapy modalities, providing better sternotomy healing for patients who have undergone CABG surgery, compared with traditional wound care management alone. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.

The aim of this study was to investigate the effects of class IV high-level laser therapy (HLLT) versus class IIIb low level laser therapy (LLLT) on sternotomy healing following coronary artery bypass grafting (CABG) surgery. Forty- five patients male patients who had CABG surgery in the age range of 45-65 years were divided randomly into three equal groups (n = 15). The group HLLT laser received HLLT plus traditional wound management, while the group LLLT laser received LLLT plus traditional wound management. The control group only received a traditional wound management in form of saline irrigation, dressing, and topical bivatracin spray according to hospital protocol. All groups were offered 10 sessions over 4 weeks. HLLT and LLLT were found to be the most effective methods for sternotomy healing post-CABG surgery, with HLLT offering superior performance in the case of the high deep penetration and significance less time needed to deliver the same joules/ cm compared to LLLT used for the wound site.

Eligibility Criteria:
Inclusion Criteria:

* aged between 45 and 65 years
* male gender; haemodynamic stability
* body mass index (BMI) from 18.5 to 29.9 kg/m2
* Non-infected sternotomy site
* Normal ejection fraction to ensure normal vascularity.

Exclusion Criteria:

* included previous thoracic surgery
* emergency or urgent coronary artery bypass surgery
* respiratory insufficiency after surgery, manifesting hypoxemia with partial oxygen pressure in arterial blood \< 60 mmHg; Ejection fraction \< 50%
* Paramedian sternotomy which may cut wire causing sternal mobilization which is the start of deep wound infection
* Bilateral mammary harvesting which decrease blood flow to sternum; low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias or hypotension, according to the American College of Cardiology Foundation and American Heart Association
* other medical conditions, such as diabetes, uncontrolled hypertension and obesity.
Protective Step Training in Parkinson's Disease

The primary purpose of this project is to determine the preliminary effectiveness of protective step training to improve balance and reduce falls in people with Parkinson's disease (PD) and postural disturbances. A secondary purpose is to understand which baseline patient characteristics predict responsiveness to treatment. By informing 1) the effectiveness of a promising rehabilitative intervention, and 2) the selection of the participants that will be most responsive to treatment, these data may enhance clinicians' ability to treat balance disturbances in people with PD. Importantly, protective step training, described in this proposal, can be quickly deployed in the clinic at minimal cost. Therefore, if shown to be effective via this and subsequent trials, this approach can be easily integrated into care, immediately impacting a large number of people with PD.

This project contains 3 aims: Aims 1 and 2 address the primary goal of this project: Determining the effectiveness of protective step training. Aim 1 will test whether perturbation training can improve protective stepping in people with PD with postural dysfunction. Aim 2 will test whether improvements are retained over 2 months and generalize to untrained perturbation tasks (which may be important for real world situations). Importantly, investigators will also gather exploratory data regarding the effect of perturbation training on falls. Aim 3 addresses the secondary goal of this project: Determining for whom protective step training is most beneficial. Aim 3 will relate behavioral factors and neuroimaging outcomes to the magnitude of improvement in protective stepping. All aims will be tested in people with PD who have postural disturbances.

To complete these aims, participants will undergo 12 visits to the laboratory over the course of about 5 months. These will include 6 "training visits" over the course of 2 weeks, surrounded by 6 "assessment" visits before and after the training. During assessment visits, investigators will assess the ability to step quickly in response to a loss of balance (e.g. a slip), as well as thinking assessments and, if eligible, investigators will complete an MRI. During training visits, investigators will train the ability to step quickly in response to a slip.

In this study, participants will serve as their own controls. As such, there is no randomization to multiple groups.

Eligibility Criteria:
Inclusion Criteria:

* Neurologist diagnosed PD
* Postural Instability / Gait Dysfunction (PIGD)
* Ability to stand unaided for 5 minutes

Exclusion Criteria:

* non-PD related neurological pathology
* orthopedic impairments affecting balance
Efficacy of Pathogen Inactivation Strategies for Platelet Transfusion

This is a prospective randomized clinical trial designed to determine the hemostatic ability of pathogen reduced platelet, when compared to non-pathogen reduced platelets suspended in platelet additive solution.

The safety and efficacy of pathogen reduced (PRT) platelets (PLTs) have been investigated in several controlled clinical studies. Most of these clinical studies evaluated the efficacy of PRT PLTs during prophylactic transfusion evaluating post-transfusion platelet count increments, rather than platelet function during bleeding episodes. During massive transfusion events and immediate resuscitation, PLT transfusion is recognized as an important determinant of a positive patient outcome. PLT transfusion is important to control bleeding in patients undergoing cardiac surgery on cardiopulmonary bypass because cardiopulmonary bypass alters platelet function. Thus, transfusion of functional platelets is required to control bleeding post-operatively. In this context, the investigators propose to investigate whether efficient hemostasis associated with platelet transfusion differs with the use of pathogen reduced PRT PLTs compared to non-pathogen reduced PLTs that are suspended in platelet additive solution.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Preoperative evaluation for risk of transfusion: platelet count \< 200,000/mcl, OR anticipated time on cardiopulmonary bypass \> 90 min, OR complex cardiac surgery, OR use of preoperative antiplatelet therapy within 3-5 days of surgery.

Exclusion Criteria:

* Patient that lack the ability to consent
* Patients with the diagnosis of idiopathic thrombocytopenia purpura,
* Patient with the diagnosis of heparin-induced thrombocytopenia.
Longitudinal Study Evaluating Recovery After Scheduled Cesarean Delivery

The purpose of this research is to describe how patients recover after scheduled C-section for the first 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older who receive neuraxial anesthesia for elective cesarean delivery

Exclusion Criteria:

* Less than 18 years of age
* Gestational age less than 32 weeks
* Women whose infants have died or are in the neonatal intensive care unit after delivery
* Inability to read or understand written English
* Failed neuraxial anesthesia requiring general anesthesia
ROMTECH PortableConnect Rehabilitation Device Usage Post Unilateral Total Knee Arthroplasty (TKA)

ROMTech is focused on transforming the healthcare market by delivering lower extremity rehabilitation systems that are effective, efficient for patient use, cost-effective, and provide better patient outcomes while simultaneously decreasing rehabilitation and overall recovery times.

The patented technology of the ROMTech PortableConnect can improve the rehabilitation protocol for lower extremities in shorter time periods. The focus of this study is to compare the effectiveness of the ROMTech PortableConncect device only rehabilitation program following total knee arthroplasty to an active comparator group of continuous passive motion with a standard of care combination HHPT and OPPT rehabilitation program. The technology used to develop the ROMTech PortableConnect device has been reported in a pilot study to tend to be highly effective in decreasing the recovery time of patients post TKA, as discussed in the findings from the pilot study with the ROMTech Pro Cycle. The expedited recovery resulting from use of the ROMTech rehabilitation technology is noted to be contributed to the ability of the ROMTech technology to achieve a more rapid range of motion in this patient population.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age at screening visit.
* Documentation of a definitive diagnosis of osteoarthritis of the knee requiring total knee arthroplasty.
* Scheduled or willing to schedule TKA procedure within the timelines consistent with the study enrollment period. This includes up to a 28-day screening window prior to the scheduled surgery.
* Willing to consent to outpatient, home-based physical therapy, CPM, or the ROMTech protocol
* Able to provide written informed consent.
* Willing and able to participate in and complete all study assessments, questionnaires, and procedure

Exclusion Criteria:

* Inability to provide informed consent.
* Inability to understand and complete study related assessments and procedures.
* Other scheduled surgical knee procedures in addition to the TKA.
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data.
* History of musculoskeletal or neurological disorders that limit physical function including but not limited to severe spine OA, contralateral leg issues limiting mobility, and other disorders as identified by the investigator
* Planned additional knee joint surgery within 3 months of the primary scheduled TKA
Study of Promethazine for Treatment of Diabetic Gastroparesis

Adult diabetic patients (ages 18-65) with gastric emptying scintigraphy-confirmed delayed gastric emptying will be recruited to participate in the study. Using double-blinded methodology, study participants will be randomly assigned to one of two treatment arms: promethazine 12.5 mg three times daily for 28 days or placebo three times daily for 28 days. The primary outcome will be the change in gastroparesis symptom severity, as measured by the Gastroparesis Cardinal Symptom Index (GCSI) at four weeks compared to baseline. Participants will be seen for a clinic evaluation at weeks 0, 2 and 4, during which symptom scores, adverse events and treatment compliance will be assessed. It is hypothesized promethazine treatment will be superior to placebo in improving symptoms of gastroparesis.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 18-65 years of age
* clinical diagnosis of diabetic gastroparesis.
* EGD without evidence of gastric outlet obstruction within the past five years
* gastric emptying scintigraphy test demonstrating \>10% solid food retention at 4 hours within the past three years.

Exclusion Criteria:

* the inability or unwillingness to provide informed consent
* currently pregnant or breast feeding
* prior placement of a gastric stimulator
* pyloric botulinum toxin injection within the past 12 months
* prior gastric surgery
* history of a connective tissue disorder
* use of narcotic medication within the past four weeks
* hemoglobin A1C \>12 mg/dL within the past 3 months
* current or recent (within past 4 weeks) use of promethazine, metoclopramide or domperidone
* hypersensitivity or prior adverse reaction to promethazine
* concomitant use of phenothiazines (i.e. prochlorperazine, chlorpromazine) or other agents likely to increase extrapyramidal reactions
* concomitant use of tiotropium or ipratropium
* narrow angle glaucoma
* urinary retention
* Parkinson's disease
* significant psychiatric disease
* history of seizure.
It is Possible to Maintain the Performance of Screening Colonoscopies Under MEOPA During the Covid 19 Epidemic Period When Access to the Operating Room is Limited

Feedback: during the COVID-19 epidemic, access to operating theaters was restricted so that anesthetists and nurse anesthetists could reinforce the resuscitation workforce.

The MEOPA was used as an alternative to sedation, allowing colonoscopies to be carried out, colon polyps and colorectal cancers to be detected.

Colonoscopy is a major procedure for screening for cancers and diagnosing colorectal lesions. In France, general anesthesia remains the most widely used sedation method for colonoscopy. Faced with several constraints such as difficulty of access to the operating room, length of hospitalization and contraindications to general anesthesia, several sedation methods have been adopted.

The best known is sedation by MEOPA (equimolar mixture of oxygen protoxide of nitrogen) marketed under the name of Kalinox. It is offered as a second-line treatment after general anesthesia.

Since March 2020, the COVID-19 health crisis has forced us to change our care. Faced with restricted access to the operating room (anesthetists and nurse anesthetists requisitioned to participate in the care of patients in intensive care), colonoscopy under MEOPA was offered to patients who could have benefited from general anesthesia before the crisis. This monocentric retrospective descriptive study at the CHSF (Centre Hospitalier Sud Francilien) will make it possible to assess the quality of colonoscopies performed under MEOPA in the first line.

This is a feedback, the MEOPA having allowed us to continue and maintain the performance of screening colonoscopies during the COVID 19 epidemic.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who had a colonoscopy under MEOPA between January 2019 and May 2021 at the CHSF.

Exclusion Criteria:

* Colonoscopy under general anesthesia
* Refusal of data collection.
A Study of Anlotinib in Subjects With Advanced Malignancy

Anlotinib is a tyrosine kinase inhibitors (TKI) with high effective in inhibiting angiogenesis and tumor cell proliferation by targeting VEGFR, PDGFR, FGFR and c-Kit. Previous phase I trial has shown the potency of anlotinib in treating patients with various cancer types who failed in standard treatment or lack proper treatment regimen. Here, a single center, single-arm, phase II study was conducted to further validate the efficacy and safety of anlotinib in these patients.


Eligibility Criteria:
Inclusion Criteria:

* 1) 18\~70 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.

  2) Histopathologically confirmed advanced malignancy, including gynecological-related tumors, breast cancer, digestive tract tumors, melanoma, and gastrointestinal stromal tumors.

  3) Has no effective treatment choice, or failure/recurrence after conventional treatment.

  4) If has received chemotherapy, the treatment has been discontinued for at least 30 days.

  5) The main organs function are normally. 6) Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

  7) Understood and signed an informed consent form.

Exclusion Criteria:

* 1）Has other malignant tumors. 2) Has participated in other anticancer drug clinical trials within 4 weeks. 3) Has multiple factors affecting oral medication. 4) Has brain metastasis, spinal cord compression, cancerous meningitis. 5) Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

  6) Has any serious and / or uncontrolled disease. 7) Long-term unhealed wounds or fractures. 8) Has artery/venous thrombosis prior to the first dose within 6 months. 9) Has bleeding tendency or treated with anticoagulants or vitamin K antagonists.

  10) Has drug abuse history that unable to abstain from or mental disorders. 11)Has history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.

  12) According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
A Phase 1/2 Multicenter Dose Escalation and Expansion Study Of NKTR-214 In Subjects With Locally Advanced Or Metastatic Solid Tumors

This is a first in human, open-label, sequential dose escalation and expansion Phase 1 study of NKTR-214 in adult patients with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor.
* Received 1 or 2 prior lines of therapy.
* Life expectancy \>12 weeks.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
* Measurable disease per RECIST v1.1.
* Demonstrated adequate organ function within 14 days of treatment initiation.
* Subjects must be recovered from the effects of any prior chemotherapy, immunotherapy, other prior system anticancer therapy, radiotherapy or surgery.
* Women of childbearing potential must agree to use highly effective methods of birth control.
* All participants must agree to use double barrier contraception during study participation and for at least 2 months after the last dose of study drug.
* Additional criteria may apply.

Exclusion Criteria:

* Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR-214.
* Females who are pregnant or breastfeeding.
* Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
* Active central nervous system (CNS) metastases.
* Prior surgery or radiotherapy within 14 days of therapy.
* Participants who have had \< 28 days since the last chemotherapy, immunotherapy, biological therapy, or \< 14 days from approved tyrosine kinase inhibitor (TKI) therapy (sunitinib, sorafenib, vemurafenib, dabrafenib, cobimetinib), or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone or equivalent before administration of the first dose of study medication.
* Participants' inability to adhere to or tolerate protocol or study procedures.
* Additional criteria may apply.