cyrilzakka/clinical-trials huggingface dataset:
Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients

Prospective, sham controlled, interventional study to evaluate the extent to which PulseHaler improves the functional status of Chronic Obstructive Lung Disease (GOLD) II-IV Chronic obstructive pulmonary disease (COPD) patients.

PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD . PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies and for pre-defined lengths of time.

The study is intended to evaluate the extent to which PulseHaler improves the functional status of GOLD II-IV COPD patients after 4 weeks of treatment 3x / day.

And To evaluate the extent to which improvements are maintained over a subsequent 2 weeks when treatments are tapered to 1x daily.

Eligibility Criteria:
Inclusion Criteria:

* Investigator confirmation of GOLD II-IV COPD
* Successful completion of Incremental Exercise Test (IET)
* FEV1 \< 60% predicted
* Post-bronchodilator FEV1/FVC ≤ 0.7
* 55-75 years old
* Signed informed consent by subject (required cognitive capacity)

Exclusion Criteria:

* SpO2\<80% at IET
* Unable to achieve a CWR test duration at visit 2 between 3 and 8 minutes
* Exercise limitation unrelated to diagnosis of COPD
* Systemic (oral, IV, IM) steroid use for acute exacerbation in the 30 days prior to screening
* Baseline CAT Score \<10
* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptives
* Severe cardiac disease, e.g., Congestive Heart Failure grade , hemodynamic instability,
* Acute myocardial infarction within last 3 months
* Coronary artery bypass graft within last 3 months
* Epilepsy, raised intracranial pressure, acute sinusitis or nosebleed
* Pulmonary embolism, untreated air leaks, tension pneumothorax, bronchopleural fistula, active hemoptysis, pulmonary haemorrhage, Large pulmonary bullae, intrathoracic obstruction from tumor or foreign body
* Unhealed dental, head, neck, ear, nose \& throat, thoracic or upper gastro-intestinal tract surgery or trauma
* Unhealed broken ribs
* Esophageal varices
* Anxiety, Depression, history of Mental illness
* Dependence on positive pressure ventilation (i.e. 24/7 non-invasive ventilation).
* Cannot perform spirometry
* Enrollment in another interventional study
* Any medical condition for which the investigator deems the subject unable to participate in the study
Multidisciplinary Evaluation of Elderly Patients With Digestive Cancer (EPODIG-G)

This is a monocentric, comparative, open-label, randomized parallel group study enrolling elderly subjects hospitalized in Strasbourg Europe Cancerology Institute (ICANS), starting chemotherapy or targeted therapy for the treatment of digestive cancer.

At the ICANS an EPODIG-G program, consisting in a coordination of supportive care that are existing in the Institute, is proposed to elderly patients with digestive cancer. The purpose of this study is to evaluate the impact of this early multidisciplinary geriatric program (EPODIG-G), when it is initiated before therapeutic treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 75 years old
* Performance status 0, 1 or 2
* Diagnostic of digestive cancer, all stages (adjuvant or metastatic), with an indication for chemotherapy treatment or targeted therapy
* Patients previously treated with one or several lines of chemotherapy for this digestive cancer are eligible
* Estimated life expectancy ≥ 3 months
* Patients able to speak, read and understand French
* Signed informed consent from the patient
* Patients must have a social security coverage

Exclusion Criteria:

* History of differentiated neuroendocrine tumors grade 1 or 2 (pancreas, small intestine)
* History of another treated cancer during the last five years
* History of major surgery and/or curative radiation therapy during the last 4 weeks before inclusion
* Patients unable to submit to medical follow-up for geographical, social or psychological reasons
* Patients placed under guardianship
Water Method in Elder Patients With Unsedated Colonoscopy

Water method with water exchange has been shown to reduce medication requirement and pain experienced during colonoscopy. It increases the success rate of cecal intubation in sedated and unsedated patients undergoing screening colonoscopy. Exchange of water during scope insertion minimizes distension of the colonic lumen and decreases loop formation. Exclusion of air from the colon during insertion by omission of air insufflations and suction removal of residual air prevent elongation of the colon. These maneuvers facilitate colonoscopy insertion in average patients and may enhance the success of difficult colonoscopy.

Older age is independently associated with incomplete colonoscopy, the investigators postulate that these patients may benefit from using the water method for colonoscopy. In this proposal the investigators test the hypothesis that compared with conventional air insufflations the water method with water exchange significantly enhances the success rate of cecal intubation in elder patients.

The aim of the study is to compare the outcome of colonoscopy using the water method versus the conventional air method in elder patients. The primary outcome is cecal intubation success rate. The secondary outcomes include cecal intubation time, maximum pain score during colonoscopy, overall pain score after colonoscopy and adenoma detection rate.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 70

Exclusion Criteria:

* History of colorectal surgery
* Severe colonic stricture or obstructing tumor
* Patients who cannot give informed consent and those who are hemodynamically unstable
Efficacy of Microcurrent Therapy After Eccentric Exercise

15 participants will be included in the present study. They will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:

* session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery.
* session 2 and 5: experimental session (the test battery followed by the provocative task, the test battery, the one-hour "treatment" and the test battery again).
* session 3 and 6 (performed 2 days later): the test battery.

The test battery included flexibility, functional, pressure pain threshold tests.

The provocative task was an isokinetic eccentric task for knee flexors and extensors.

The treatment was either a microcurrent therapy or a placebo microcurrent therapy.

Objective:

To study the efficacy of microcurrent to reduce DOMS (Delayed Onset Muscle Soreness) occuring after an eccentric exercise

Methods:

Experimental protocol

Participants will attend two groups of three sessions (i.e. sessions 1-2-3 and sessions 4-5-6) spaced by 3 months:

* session 1 and 4 (performed a few days before the experimental session): session for participants to get familiarized with the test battery.
* session 2 and 5: experimental session: the test battery followed by the provocative task, the test battery, the one-hour "treatment" (real microcurrents at one of the session and placebo microcurrents at the other one) and the test battery again.
* session 3 and 6 (performed 2 days later): the test battery.

Before starting session 2, patients will be randomized into the microcurrent group or the placebo microcurrent group. Three months later, participants will change of group.

The Test Battery: it will be conducted by a blind (to the treatment) investigator. It will include knee flexor and extensor flexibility tests, a functional test (unilateral " counter-movement jump "), a pain to measure pain threshold of thigh muscles and an isometric maximal voluntary contraction (MVC) test of knee flexors and extensors.

The Provocative task: 40 isokinetic eccentric contractions of knee flexors and extensors.

The one-hour Treatment: with the participant lying on an examination table, several electrodes were located over the muscles involved in the provocative task. The microcurrent therapy was then started. It was stopped after 5 seconds in the "Placebo group" and after one hour in the real "Microcurrent group". The microcurrents were delivered by the machine B-E-St®.

Follow-up: in addition to the 48hours follow-up (session 3/6), participants will fill in a pain visual analogue scale each day after the session 2/5.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic subjects

Exclusion Criteria:

* practice of sports \>3h per week
* present pain in the lower limbs
* history of thigh muscle injuries
* recent injury (last 3 months) of the lower limbs
* recent (last 3 months) plyometric exercises or lower limbs strengthening program.
Radiotherapy Combined With Immunotherapy for Brain Metastases of Non-small Cell Lung Cancer

This is a Retrospective, Multicenter, Controlled Study to Evaluate Immunotherapy and Radiotherpay for Brain Lesions as a Potential Treatment for Patients with Brain Metastasis in non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

Experimental group:

1. 18 years old ≤ age ≤ 75 years old, no gender limitation;
2. NSCLC who have received radiotherapy for brain lesions + PD-1/PD-L1 immunotherapy;
3. Histologically confirmed as NSCLC;
4. Imaging confirmed brain metastasis (CT or MRI);
5. The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1

Control group:

1 18 years old ≤ age ≤ 75 years old, no gender limitation; 2 NSCLC who has received radiotherapy for brain lesions; 3 Histologically confirmed as non-small cell lung cancer; 4 Imaging confirmed brain metastasis (CT or MRI); 5 The presence of imaging-evaluable lesions can be evaluated in accordance with RECIST 1.1

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Exclusion Criteria:

1 The age is less than 18 years old, regardless of gender; 2 Histologically confirmed as NSCLC 3 Imaging confirmed the absence of brain metastases 4 NSCLC with brain metastasis only received chemotherapy or targeted therapy, and did not receive radiotherapy or immunotherapy

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Investigating the Postprandial Glucose Metabolism After Treatment With Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the postprandial glucose metabolism after treatment with faster-acting insulin aspart in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18-64 years (both inclusive) at the time of signing informed consent
* Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Smoker (defined as a subject who is smoking at least five cigarettes or the equivalent per day) who is not able or willing to refrain from smoking or use of nicotine gum or transdermal nicotine patches during the inpatient period
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events.

Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 or greater
* clinically or histologically confirmed diagnosis of lichen planopilaris or frontal fibrosing alopecia

Exclusion Criteria:

* known allergy or hypersensitivity to naltrexone
* patients with concurrent use of opioids
* active depression, schizophrenia, and bipolar disorder
The Effect of Stretching Exercises on Vascular Function, Blood Flow, and Walking Function in Middle and Older Adults

This study examines the relationship between circulation and walking speed after performing 8-week stretching exercises.

This study examines the relationship between circulations and walking speeds. Most studies in the field of stretching exercises have only focused on improvements of endothelial functions in younger population; however, I aim to emphasize its effects on different populations, such as people with frailty, low physical activity level, weakness and postoperative status. Previous research has established that stretching exercises can improve walking function by modulations of musculoskeletal or neuromuscular system. The importance and originality of this study are that it explores the relationship between circulation and walking speed. Due to the inability to extrapolate outcomes; short-term effect of improved blood vessel function; the unclear mechanism of stretching exercises; and considering the different physical fitness groups, I design a home-based, low-dose, and anatomic chain-based stretching exercises to verify the possible mechanism and effects.

Eligibility Criteria:
Inclusion Criteria:

1. age between 20-85 years old
2. Follow instructions
3. Walk with/without assistive technology

Exclusion Criteria:

1. Unstable acute or chronic health conditions
2. Peripheral vascular diseases
3. Non-musculoskeletal problems that would limit stretching exercises
4. Participate in other exercise programs
Safety Study of Stem Cell Transplant to Treat Limbus Insufficiency Syndrome

The purpose of the study is to determine whether allogenic bone marrow stem cell transplant is safe and effective in the treatment of limbus insufficiency syndrome versus allogenic limbus stem cell transplant.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female older than 18 years.
* Signed Informed consent
* Negative pregnancy test at inclusion for any potential childbearing female.
* Compromise of contraceptive method during all trial for any potential childbearing female.
* Diagnosis of Ocular Surface Failure due to Limbus Insufficiency Syndrome, based in any of the published characteristics as corneal surface neovascularization, loss of corneal transparency, epithelial irregularities, history of punctate keratitis, erosions or repetitive ulcers and presence of symptoms and confirmed by the presence of epithelial phenotype cells assessed with conjunctival impression cytology.
* Availability for all the scheduled visits during the study

Exclusion Criteria:

* Uncontrolled systemic disease (e.g. hypertension or diabetes) or any disease that under medical decision might put the patient at risk during the surgery or follow-up examinations or may cause any hazard in data analysis.
* Active ocular infection in any eye. If the infection can be cured, inclusion can be considered after 30 days of inactive infection since its end.
* Alterations in lid statics / dynamics or any other pathology (e.g. severe dry eye syndrome) except the one that originated the Limbus Insufficience that under medical opinion might alter the results. Any of these must be corrected 3 months prior to patient inclusion, before reconsidering rescreening.
* Limbus insufficiency syndrome which has not been previously treated with all medical (not surgical) procedures available.
* No availability for all scheduled visits during the study.
* Any other circumstance under investigator´s opinion that prevents patient inclusion even though normal inclusion and exclusion criteria are met.
A Study of Radiation Toxicity in the Liver Using MRI-Based Perfusion

Researchers at the the University of Michigan are conducting a research project to assess how a course of radiation therapy changes the way blood flows through the liver. To be able to do this, the researchers will be using MRI (magnetic resonance imaging) scans completed before, during, and after radiation therapy. MRI's will be done on 4 or 5 occasions. On each occasion, you will be injected with a fluid called gadolinium (a contrast agent) before getting an MRI. This contrast agent makes it easier for the Researchers to see your organs in the scans, and causes any abnormal areas to become very bright on the MRI. This agent will be injected into a vein in your arm or leg. Each MRI scan will last approximately 45 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years of age.
* The patient's planned cancer management is radiation to the liver with or without chemotherapy.
* Patients must have a performance status of 0-2 and a life expectancy of at least 3 months.
* Patients should have no contraindications to having a contrast enhanced MRI scan.

Exclusion Criteria:

* Women who are pregnant or breastfeeding are excluded.
* Prisoners are excluded
Effect of Obstructive Sleep Apnea Syndrome on Insulin Sensitivity and Cardiovascular Risk in PCOS Adolescents

Polycystic ovary syndrome (PCOS) is one of the most common disease caused by hormonal imbalance and is also associated with overweight and obesity. It affects 5-10% of adolescent girls and women capable of having children. Polycystic ovary syndrome is associated with missed menstrual periods, hormonal imbalance, being overweight, and with a form of diabetes. Girls with polycystic ovary syndrome may have a breathing problem known as "sleep apnea." Sleep apnea may cause a person to stop breathing for short periods of time while sleeping. People with polycystic ovary syndrome are thirty times more likely to develop sleep apnea than those who do not have PCOS. If sleep apnea is not treated, it may lead to daytime sleepiness, poor school performance, high blood pressure, heart disease and diabetes. The purpose of this study is to understand how insulin function is affected in presence of sleep apnea in girls with polycystic ovary syndrome between 13-21 years of age as compared to girls with PCOS without sleep apnea. Insulin is one of the hormones made in your body to convert food into energy. In people with increase weight body cannot use insulin properly. The investigators also want to see if insulin action is also affected by sleep apnea.

See above.

Eligibility Criteria:
Inclusion Criteria:

* Female.
* Ages 13-21
* PCOS
* BMI \>95%ile (Obese group) or \<85%ile (Lean group)
* Controls: ages 18-21, regular menses, BMI \<85%ile

Exclusion Criteria:

* Breastfeeding.
* Pregnant.
* Use of any steroid preparations (including hormonal contraception), medications known to alter insulin secretion and/or action within 3 month (including Metformin)
Prediction of Amyloid and Mild Cognitive Impairment in Early Stage Alzheimer's Disease From Remote Speech Phenotyping

The S22 study investigates, in a cross-sectional study, the ability of algorithms that analyse acoustic and linguistic patterns of spoken language to predict the presence of amyloid positivity in early stage Alzheimer's disease, specifically in Mild Cognitive Impairment (MCI) and cognitively normal (CN) cohorts; and whether similar algorithms can predict cognitive functioning, in classifying MCI vs CN.


Eligibility Criteria:
Inclusion Criteria:

* Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 30 months at the time of consent for Arm 2 and Arm 4 participants (amyloid negative Arms).
* Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 60 months at the time of consent for Arm 1 and Arm 3 (amyloid positive Arms).
* Subjects must be aged 50-85 (inclusive).
* Subjects must have MMSE scores of 23-30 (inclusive) based on a test not older than 1 month at the time of the visit.
* Date of diagnosis (if applicable) maximum of five years prior to consent.
* Subjects' first language must be English.
* Willing to participate in a study investigating speech and cognitive impairment.
* Able to provide valid informed consent.
* Able to use, or has a caregiver who is able to use a smartphone device.
* Has access to a smartphone device running an operation system of Android 6 or above; or iOS 10 or above.

If taking part in the study through virtual visits, the following inclusion criteria also applies:

* Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
* Has access to a personal computing device of that is running an operating system of macOS X with macOS 10.9 or later, or Windows 7 or above, or Ubuntu 12.04 or higher; OR has access internet browser software Internet Explorer version 11 or above; or Microsoft Edge version 12 or above, or Firefox version 27 or above, or Google Chrome version 30 or above, or Safari version 7 or above; AND capable of audio and video recording; AND able to connect to the internet.

Exclusion Criteria:

* Clinically significant unstable psychiatric illness in 6 months.
* Diagnosis of General Anxiety Disorder.
* Current, or history within the past 2 years of major depressive disorder diagnosis (according to DSM-5 criteria83); or psychiatric symptoms that, in the opinion of the investigator, could interfere with study procedures.
* History or presence of stroke within the past 2 years.
* Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
* The participant is using drugs to treat symptoms related to AD, and the doses of these drugs were not stable for at least 8 weeks prior to consent.
* Participant is, or previously has been enrolled in the Sponsor's NOV-0100 or NOV-0110 studies.
A Single and Multiple Dose Study of PF-05221304 in Healthy Japanese Adults

The current study is designed to evaluate the safety, tolerability and pharmacokinetics of PF-05221304 in healthy Japanese adult subjects following single and multiple dose administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects who, at the time of screening, are between the ages of 20 and 55 years, inclusive.
* Body mass index (BMI) of 17.5-30.5 kg/m2 inclusive; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) or clinical findings at Screening.
Liposomal Doxorubicin and Docetaxel in Metastatic Breast Cancer

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer

Evaluation of safety and efficacy of a treatment associating Pegylated Liposomal Doxorubicin + Docetaxel in patients with metastatic breast cancer. Patients will receive pyridoxin to prevent cutaneo-mucinous toxicities.

Eligibility Criteria:
Inclusion Criteria:

* first metastatic chemo line
* presence of measurable or bone lesion
* at least one lesion outside the radiated areas
* can have previously received hormonotherapy, chemotherapy in adjuvant phase, radiotherapy if older than 4 weeks

Exclusion Criteria:

* only local tumoral progression
* symptomatic cerebral metastasis
* neuropathy \> NCI-CTC 2
* previous cancer within 10 years _ previous cancer within 10 years