cyrilzakka/clinical-trials huggingface dataset:
Telemedicine Intervention to Improve Physical Function

This project is investigating whether a one-year in-home exercise program will reduce the rate of falls and improve strength and quality of life in patients with Parkinson's disease.

Background/Rationale:

Parkinson's disease (PD) is the second most common neurodegenerative disease, affecting over one million Americans. The cardinal clinical manifestations of PD are motoric, which limit functional mobility leading to difficulty working, caring for family members, managing a household, and overall decreased independence and quality of life (QOL). A wealth of growing data indicates tremendous benefits of exercise for patients with PD. Not only have exercise programs been shown to improve motor function and reduce the risk of falls, but also improve overall QOL and possibly the very course of disease pathology. However, programs that involve supervision in the home of people with PD are expensive to roll out widely, and programs that involve people with PD traveling to a central site not only result in non-compliance over time because of difficulty getting to the site, but also rule out the involvement of a large number of people with PD who simply live too far from larger centers where such programs are typically established.

Objective:

The investigators hypothesize that a one-year in-home exercise program, centered around remote, real-time instruction and supervision, will reduce the rate of falls and improve strength and QOL in patients with PD.

Methods:

The proposed study is a randomized controlled trial of a structured exercise program, evaluating effects on fall rate, physical functioning, and QOL. Community-dwelling people with PD will be randomized either to a group who receives structured and remote exercise instruction and supervision in real-time or a group who is taught a lifestyle exercise program. Subjects will be male and female Veterans with a physician diagnosis of idiopathic, typical PD, with at least 2 of 3 cardinal signs of PD, and response to dopaminergic medication. The interventions will last one year.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of idiopathic, typical Parkinson's disease (PD)
* At least 2 of 3 cardinal signs of PD
* Response to dopaminergic medication

Exclusion Criteria:

* Angina pectoris
* History of myocardial infarction within 6 months
* History of ventricular dysrhythmia requiring current therapy
Clavipectoral Block Versus Interscalene Block for Postoperative Analgesia in Midshaft Clavicular Surgery

The aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries.

The aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries. Preoperative full precise medical history will be taken from patients. Routine investigations will be done to all patients including ECG and laboratory investigations as CBC, AST, ALT, INR, PT and PTT. Demographic data as age and weight will be recorded. All patients will be consented for every anesthetic and surgical procedure to be done. For all patients, on arrival to the operating room, ECG, heart rate (HR), non-invasive blood pressure, and pulse oximetry will be monitored. Patients will receive 0.03 mg/kg of IV midazolam as anxiolytic and 3 L/ min nasal oxygen.

Then, in supine position, the diaphragmatic excursion measurement will be performed on the hemidiaphragm at the same side of the study block. Excursion amplitude will be defined as the craniocaudal perpendicular distance from the minimum to the maximum point of diaphragm excursion. Diaphragmatic excursion measurements will be performed before induction of general anesthesia and performing the block technique and at 3 hours after the block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours.

After that, induction of GA will be performed by injecting intravenous (IV) 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.5 mg/kg atracurium.

Then, the patients will receive one of the study blocks as following:

Group A: This group will receive ultrasound-guided clavipectoral fascia plane block.

Group B: This group will receive ultrasound-guided interscalene plexus block.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 21 to 60 years.
* American Society of Anesthesiologists (ASA) class I and II status.
* Of both sexes.
* Patients undergoing elective midshaft clavicle fracture open reduction and internal fixation surgery.

Exclusion Criteria:

* Patient refusal.
* American Society of Anesthesiologists (ASA) class llI and IV status.
* Patients with bleeding disorders.
* A history of relevant drug allergy to any of the used drugs.
* Alcohol or drug abuse and opioid dependence.
* Pregnant female patients.
* Patients with BMI above 30 kg/m2.
* Patients with infection at site of the fracture or the block procedure.
* Patients with reduced pulmonary functions due to chronic obstructive pulmonary disease (COPD), uncontrolled asthma, pneumothorax or pleural effusion.
Illness Related Distress in Women With Clinically Localized Cutaneous Melanoma

The purpose of this study is to examine the experiences and quality of life of women who have been treated for melanoma. By quality of life, we mean how they are feeling about different aspects of their life. In this study, we are especially interested in their feelings about survival, physical appearance and any family concerns. We will administer a series of QOL questionnaires, data sheets with many questions, to get their response to measure their feelings about these issues.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clinically node-negative primary cutaneous melanoma.
* Patients participating must be female
* Patients must have completed surgical treatment for melanoma at least 10 days ago and less than 2 years at the time of study entry.

Exclusion Criteria:

* Prior history of cancer with the exception of squamous or basal cell carcinoma of the skin.
Sparing Diaphragm; ISO Block Versus Low Volume Scalene Block

For shoulder analgesia, both ISO block and low volume scalene (LVS) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (HDP).

The aim of this study was to compare the incidence of HDP and the analgesic efficacy of the LVS block versus ISO block.


Eligibility Criteria:
Inclusion Criteria:

* patients who were scheduled for arthroscopic shoulder surgery

Exclusion Criteria:

* aged \<18y
* BMI \>35,
* ASA greater \>III,
* an infection at the injection site
* has a contraindication for laryngeal mask or the medications used in this study.
CRT( Chemo-Radiation Therapy) Patterns and Short-term Outcomes on Unresectable NSCLC and SCLC in Routine Practices in Russia

This is a multi-center, non-interventional, study with the aim to access routine practice of diagnostic and treatment approaches in patients with NSCLC and SCLC in 50 largest oncology centers in Russian Federation. The data for all 2000 patients with LA NSCLC and LS-SCLC who receiving CRT will have been collected for 2 years from the primary medical records. Demographic and clinical characteristics of the patients, information of routine diagnostics procedures and treatment approaches for patients with unresectable LA NSCLC and LS-SCLC and the treatment results of the end of CRT will be collected. Information about any specific NSCLC or SCLC treatments following CRT (e.g., durvalumab) will not be collected in the study. Patients with NSCLC and SCLC meeting the inclusion criteria will be prospectively enrolled into the study. Study procedures will comply with all the local regulatory requirements regarding AE reporting (pharmacovigilance). Study design considers secondary data collection approach using existing patients' medical records, after patients' visits according to routine sites' practice. Data for visit (record) 1 will be collected at the start of CRT (concurrent or sequential), and data for visit (record) 2 will be collected after the last dose of RT and with CT control results available, but the time frame for this data collection is expected to be no later than 6 months after visit 1.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Provision of written informed consent
3. Patient received at least one RT dose under prescribed CRT (concurrent or sequential) for definitive treatment of locally advanced NSCLC (stage II-III, unresectable or inoperable NSCLC, including locoregional recurrence and patient's refusal to undergo surgery) or LS-SCLC based on local MDT decision
4. Patient is currently undergoing RT (preferably no more than 10 doses)

Exclusion Criteria:

1. Participation in another clinical study with an investigational product during the last 3 months
2. Confirmation that the subject was already included in this study before
3. Absence of written informed consent form
4. Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database.
Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.

Primary objectives:

* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas;
* Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas;
* Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).

Secondary endpoints will be:

1. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);

• The change in walking performance before and after the rehabilitation treatment.


Eligibility Criteria:
Inclusion Criteria:

- Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.

Exclusion Criteria:

* Patients with recurrent tumors;
* patients with metastatic disease;
* patients with palliative surgery;
* patients with amputations.
Clinical Application of Comprehensive Intervention for PED Based on Neuroregulatory Mechanism

This study aims to establish a practical comprehensive intervention program for dysphagia after extubation in adult ICU patients based on the best evidence of its assessment and intervention, through expert panel discussion and Delphi method. In addition, combining the preliminary experimental results of vagus nerve stimulation applied to PED patients, we further develop a comprehensive intervention program for dysphagia after extubation based on neural regulation mechanism. Finally, the implementation effect of this PED comprehensive intervention program based on neural regulation mechanism will be verified through clinical application.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who met the diagnostic criteria of PED were changed to SSA score ≥24
2. aged from 18 to 90 years old;
3. oral or nasotracheal intubation for ≥48 hours;
4. Clear mind
5. Glasgow score ≥13 points, with good cooperation ability;
6. There was no contraindication to oral feeding after extubation

Exclusion Criteria:

1. Other diseases that affect swallowing function (such as stroke, Parkinson's disease, head and neck deformity, radiotherapy after head and neck cancer, burn with inhalation injury, esophageal cancer, chronic obstructive pulmonary disease, etc.);
2. history of reflux and aspiration;
3. tracheotomy;
4. isolation treatment due to respiratory infectious diseases;
5. the presence of implantable electronic devices (e.g., pacemakers, cochlear implants);
6. Traumatic vagus recurrent laryngeal nerve injury, history of vagus nerve surgery, or vagus nerve injury
APAD2: Effects of Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble

The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.

Secondary objectives are to assess and analyze the effects of a six month programme in APA of:

* arterial tension
* weight, body composition and abdominal perimeter
* quality of life
* treatment dosage
* number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL).

Inclusion criteria:

* type 2 diabetics
* age \> 40 years
* first education in Education Diabetics Department of University Hospital Grenoble
* sedentary patients
* HbA1c \> 7%-
* BMI \> 25
* to be affiliate disease assurance
* to give consent written and inform

Judgment criteria for physical activity compliance:

* leisure time physical activity: Modifiable Activity Questionnaire
* training note-book

Judgment criteria for resistance insulin:

* Crossover (PCGL)
* HOMA and FIRI index
* HbA1c

Programme test: Rehabilitation programme in Adapted Physical Activity (APA)

Programme test period: 6 months

Study total period: 28 months

Study period for each patient: 18 months

Safety criteria: clinical compendium undesirable events

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics
* Age \> 40
* First education in the Education Diabetics Department of the University Hospital Grenoble
* Sedentary patients
* Hemoglobin A1c (HbA1c) \> 7%
* Body mass index (BMI) \> 25
* To be affiliated with disease assurance
* To give written and informed consent

Exclusion Criteria:

* Foot sore \< six months
* Renal disease - proteinuria stage
* Contraindication for exercise
* VO2 max \> 120% Wassermann standard
* Coronary pathology non-stabilization
* Arteriopathy stage 2 non-compensation
* Osteo-articular crippling problem
* Geographically distant
Acupuncture in Traumatic Brain Injury

The purpose of the study is to determine the effect of a low vs. high dose of acupuncture treatment in individuals with chronic post-traumatic headache (CPTH). A total of 36 people with mild traumatic brain injury (mTBI) suffering from CPTH will be enrolled in this study to receive acupuncture treatment for 5 weeks. Participants will be randomized into two groups: 1) Low Acupuncture group (5 treatments) and 2) High Acupuncture group (10 treatments). It is hypothesized that both treatment groups will have decreased headaches, but that 10 treatments will greater alleviate headaches when compared to 5 treatments.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide and provision of signed and dated informed consent form
* Age 18-65
* Diagnosis of mild traumatic brain injury (mTBI) (as defined by the International classification of headache disorders 3rd edition (ICHD-3); a. Either no loss of consciousness, or loss of consciousness of \<30 minutes duration, b. Glascow Coma Scale (GCS) ≥ 13, and c. Symptoms and/or signs diagnostic of concussion)
* Diagnosis of mTBI ≥3 months and ≤12 months at the time of study enrollment
* Suffering from chronic post-traumatic headache (CPTH) of any etiology (e.g. tension or migraine), with chronic defined as developed within 7 days after injury and lasting ≥3 months from the time of injury
* Stable medication regimen for ≥1 months and agree to adhere to his or her current medication treatment regimen through study participation

Exclusion Criteria:

* Non-English speaking
* History of acupuncture since diagnosis of mTBI
* History of pre-existing primary headache, defined as more than 12 days of tension-type headache annually and/or more than one migraine attacks per month in the last year
* History of any other serious neurological, psychiatric, chronic pain disorders, or seizures
* History of bleeding diathesis, other bleeding disorders, or syncope with needle puncture
* History of cardiac arrhythmia or current pacemaker, neurostimulator, or other implanted stimulation device
* Recent or active substance use disorder
* Women who are currently pregnant, lactating, or planning to become pregnant during the study
* Any other medical conditions that could affect their ability to participate in acupuncture treatments for the study duration (as determined by study investigators)
* Active participation or past participation ≤3 months in any other interventional study.
* Unwilling to participate in all study related activities
Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum

The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12\~15cm from anus and low resection as 6\~8cm.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as constipation according to Rome IV criteria
* Diagnosed as slow transit constipation
* With more than 2 years' drug treatment or with outlet obstruction or with surgical history

Exclusion Criteria:

* Colon cancer
* History of colon, rectum, anus surgery
* With severe cardio, renal, neural disease
* Pregnant patients
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients with Malignant Solid Tumors

This is a Phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) at dose of 5×10∧9VP、5×10∧10VP、5×10∧11VP in Patients With Malignant Solid Tumors. Subjects will be treated with a single dose of BioTTT001 Injection after the screening period.

This study is a single arm, open label, single center dose escalation trial. Three study drug dosage groups are pre-set, namely 5 × 10∧9VP、5 × 10∧10VP、 5 × 10∧11VP. According to the principle of dose escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.

Eligibility Criteria:
Inclusion Criteria:

1. Age range from 18 to 80 years old (including the threshold), no gender restrictions.
2. Patients with histologically and/or cytologically confirmed malignant solid tumors, who have experienced at least one-line standard treatment failure or intolerance, or lack standard treatment options. Focus on malignancies in the head and neck, colorectal cancer, skin malignancies, and cervical cancer.
3. At least one assessable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
4. Assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion).

Exclusion Criteria:

1. Known allergy to the investigational drug or its components.
2. Previous treatment with other adenovirus drugs.
3. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
4. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).
Development of Patient Centered Virtual Multimedia Interactive Informed Consent Tool to Improve Patient Comprehension and Consent

The Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent.

The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in a way that assures patient comprehension.

Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension.

The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research.

This study will be conducted over a 15 month period and will consist of 6 parts: (1) Front-End Focus Groups, (2) User Requirements Analysis, (3) Screen Prototypes Usability Focus Groups, (4) Design and Implementation, (5) Before Launch Usability Evaluation, (6) After Launch Usability Evaluation. Given the steps in the process and the changing (i.e. different) subjects/participants in each component of the development process, this study registration record primarily summarizes the final step in the development of VIC.

Eligibility Criteria:
Inclusion Criteria:

* Clinician diagnosis of asthma based on National Asthma Education and Prevention Program (NAEPP) guidelines.
* Historical evidence of variable airflow obstruction.
* Subjects are required to speak English.

Exclusion Criteria:

* \>10 pack-year smoking history.
* Active smoking within the past year.
* Other chronic lung disease or asthma variant.
* Patients will be excluded if they cannot safely undergo the studies required for participation.
* Patient or clinician refusal to participate.