cyrilzakka/clinical-trials huggingface dataset:
Post-market Evaluation of OdySight App to Monitor Near Visual Acuity at Home (TIL002)

OdySight is a mobile application allowing self-testing of visual parameters including near visual acuity and communication of the data to an online dashboard to patient's doctors. TIL-002 post-market clinical trial objective is to evaluate the near visual acuity at home, measured with OdySight application in comparison to the standardized methods. The clinical trial is intended to prove that OdySight can provide relevant data and participate in the remote monitoring of subject vision.


Eligibility Criteria:
Inclusion Criteria:

General inclusion criteria:

1. Age ≥ 18 years, all genders
2. Affiliated to or beneficiary of the French health care system
3. Signed/written informed consent
4. Already user of Odysight on a compatible smartphone/tablet
5. Patients willing and able to comply with all study and follow-up procedure

   Ophthalmic inclusion criterion:
6. Baseline binocular visual acuity with habitual correction ≥ 20/63 (3/10) AND with at least an eye ≥ 20/200 (1/10).

Exclusion Criteria:

General exclusion criteria:

1. Any pathology that is considered by the investigator as capable of affecting the quality of the main evaluation criteria.
2. Any planned surgery likely to modify patient refraction during the study (cataract surgery for example)
3. Subject not considered by the investigator or designee to correctly use ODYSIGHT modules
4. Subject unable to recognize alphabet letters or unable to correctly distinguish body laterality
5. Not French speaking patient
6. Epileptic users
Bioavailability Study Of PF-00868554 Administered As 3x250mg Oral Tablets (Wet Granulate, 3x250mg Oral Tablets (Dry Granulate) And 750mg Solution Under Fed State

This study will test two different formulations. The results will be used to select formulation for phase 3.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.

Exclusion Criteria:

* Standard for healthy volunteers.
Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial

This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.

This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.

Eligibility Criteria:
Inclusion Criteria:

1. Primary open angle glaucoma diagnosed at least 3 months ago.
2. Diagnosed with mild or moderate open angel glaucoma.
3. Use 1 or 2 kinds of glaucoma drugs.
4. Age ≥ 20 years old.
5. Participants sign the informed consent and cooperate with the experimental procedures.

Exclusion Criteria:

1. Accept any ophthalmic laser or surgery within one year.
2. High myopia.
3. Use of any drugs that affect intraocular pressure.
4. Visual acuity with correction lower than 0.2.
5. Previous or existing uveitis or retinopathy.
6. Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
7. Pregnancy or breastfeeding.
8. Refusal to sign the informed consent form.
Photon/Proton Radiation Therapy for Oropharyngeal Cancers

The purpose of this study is to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

This is an outcomes study and is designed to collect information from the questionnaire and medical records to see what effects proton radiation has on cancer and collect and analyze morbidity outcomes: incidence of xerostomia (dry mouth) and tumor control.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven squamous cell carcinoma of oropharynx (tonsillar pillars, tonsillar fossa, soft palate, base of tongue).
* Stage-grouping:

  * Stage I (T1N0)
  * Stage II (T2N0)
  * Favorable Stage III (T1N1/T2N1) and selected stage IV (T1-T2 early N2b)2 or less lymph node and 2 or less cm diameter lymph node
  * Unfavorable stage III and selected stage IV (any T, N2c/N3)
* Surgery of the primary tumor/lymph nodes is limited to incisional/excisional biopsies.
* Will receive treatment with proton radiation.

Exclusion Criteria:

* Evidence of distant metastasis.
* Previous irradiation for head and neck cancer.
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease

The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (COPD) patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.


Eligibility Criteria:
Inclusion criteria:

* Patients willing to participate with confirmed diagnosis of COPD
* 40 years of age or older
* having a 10 pack year smoking history
* able to perform serial pulmonary function tests
* able to use both a Dry powder inhaler (DPI) and Respimat device

Exclusion criteria:

* Significant other disease
* clinically relevant abnormal hematology, chemistry, or urinalysis
* history of asthma
* diagnosis of thyrotoxicosis
* paroxysmal tachycardia related to beta agonists
* history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
* active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
* significant alcohol or drug abuse
* pulmonary resection
* taking oral beta adrenergics
* taking unstable oral steroids
* daytime oxygen
* enrolled in rehabilitation program
* enrolled in another study or taking investigational products
* pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
* those who are not willing to comply with pulmonary medication washouts
Group Telehealth Behavioral Cough Suppression Therapy

The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Predominantly dry cough for at least 8 weeks
* Evaluated and treated by at least one physician for cough
* Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results
* Access to a computer or tablet that includes a camera and able to use the device independently
* Reliable internet access
* Willing to agree to maintain confidentiality of personal information (including names) related to others in the study

Exclusion Criteria:

* Under age 18
* Coughing up blood
* Current smoker of any substance
* History of smoking or 10 or more years
* Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
* Diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat).
* Complaints of swallowing difficulty
* Taking any of the following medications, which have a known side effect of cough: Benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik)
* Prior BCST treatment with an SLP or respiratory therapist
HIV Risk Reduction in Subutex Injectors in Tbilisi

This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.


Eligibility Criteria:
Inclusion Criteria:

* current opioid dependence;
* injecting buprenorphine 10 or more times in the last 30 days;
* between 25 and 50 years of age;
* buprenorphine and/or opiate positive urine test;
* not on methadone maintenance in last 4 weeks;
* stable address within Tbilisi and not planning to move;
* home or cellular phone number where can be reached;
* able to provide name of family member who knows whereabouts;
* willingness and ability to give informed consent.

Exclusion Criteria:

* currently dependent on alcohol, benzodiazepines or other CNS depressants;
* legan charges with impending incarceration;
* plans to move from Tbilisi within next 6 months;
* current participation in another treatment study;
* serious medical problems that would impair or make hazardous ability to participate;
* active TB;
* currently psychotic/suicidal;
* uncontrolled seizure disorder.
Habituation's Mechanisms in Preterm and Term Infants

Each year in France, 7 % of newborns are born preterm (before 37 weeks of gestational age (GA)). The investigators called very preterm infants those who were born before 33 weeks of GA. These very preterm infants have a higher risk of developing neurological complications like developmental disabilities or cerebral palsy. To date, early assessment of these infants is difficult and not reliable enough to detect those who are at risks of developing neurological issues. Now, the investigators need to identify earlier these infants to provide them interventions to improve their development (physical therapy for example). Consequently, the investigators are examining a study whose aim is to assess preterm infants habituation. Habituation is the newborn ability to become familiar with new environmental stimulations (noise, light...). This habituation allows the newborn to maintain his sleep even at onset of a noise or light. To study this phenomenon in infants born preterm near to corrected term (around 40 weeks of postnatal GA), will allow us to better understand neurological development of these infants. The investigators plan to compare habituation skills of preterm infants near to their theorical date of birth (40 weeks of GA) to a population of infants born at term. The investigators will also study the link between habituation abilities and sleep quality as well as neurodevelopmental outcome at the corrected age of two years old.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants: preterm infants born from 25 weeks to 32 weeks + 6 days of gestation near to 36 weeks of gestation (corrected postnatal age)
* Term infants: term newborns with a gestational age between 39 and 41 weeks of gestation at day 3 with an Apgar ≥ 1 at 1 minute of life
* For both groups: normal neurological physical examination, written informed consent of the parents

Exclusion Criteria:

* no malformation or chromosomal abnormality, life threatening disease, administration of morphine or sedatives during the 24 hours before the study, context of maternal drug addiction, deafness, no psychoactive drug or anticonvulsivants during the last month of pregnancy for the term newborns, severe neurological disease
Incretin Physiology and Beta-cell Function Before and After Weight-loss

To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Morbid obesity represents a serious health issue in Western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. Surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians without type 2 diabetes mellitus
* Normal OGTT (75 g of glucose) according to WHO's criteria
* Patients fulfilling the criteria for laparoscopic gastric banding
* Normal Hemoglobin
* Informed consent

Exclusion Criteria:

* Liver disease (ALAT \> 2 x normal level)
* Nephropathy (s-creatinin \> 130 µM or albuminuria)
* Relatives (parents/siblings) with T2DM
* Medical treatment witch cannot be stopped for 12 hours
The Effect of Renin Inhibition on Nerve Function in Diabetes

This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., \[1\] 30 participants enrolled and randomized to 300 mg of Aliskiren; \[2\] 30 participants enrolled and randomized to placebo).


Eligibility Criteria:
Inclusion Criteria:

* Individuals \>18 years old with type 1 or type 2 diabetes mellitus.

Exclusion Criteria:

* Individuals currently taking the maximum dose of an ACE inhibitor or an ARB.
* Individuals with a history of a MI, percutaneous coronary interventions, coronary artery bypass graft (CABG) surgery, acute coronary syndromes, recent/on going atrial fibrillation, frequent atrial arrhythmias, frequent ventricular arrhythmias, or acute myocardial ischemia changes.
* Individuals whose treatment dosage changes 2 months prior to the study for antihypertensive and antidiabetes medications, and the following medications that may affect the ANS: anti-tuberculosis drugs, nitrofurantoin, metronidazole, chloramphenicol, perhexiline maleate, amiodarone, clofibrate, tricyclic antidepressants, phenytoin, barbiturates, neuroleptic, antiparkinsonism drugs, and nitrated drugs.
* Pregnant or lactating females.
* Individuals with impaired renal function (i.e., creatinine \>1.5 mg/dl), a history of dialysis, nephritic syndrome or renovascular hypertension.
* Individuals with potassium levels within 0.5 mmol/L of the upper limit of normal (i.e., hyperkalemia).
Cross-Disciplinary Workplace Intervention Strategy for Chronic Musculoskeletal Disorders

Sickness absenteeism caused by MSDs is a persistent and expensive health challenge in all industrial countries including Switzerland. Despite much progress as to the cause and prevention of MSDs, they continue to be some of the most prevalent and challenging health problems with respect to the work-place and to socio-economic burden.

To improve the situation, several recent reviews recommended interventions based on the bio-psycho-social model. Work-hardening and industrial rehabilitation programs focused more on the in balance between physical and mental demands of work on one side and capacities of the individual on the other side. Therefore we propose to merge the two models into one. The result is an interdisciplinary intervention strategy witch includes work hardening, medical trainings, a cognitive behavioural approach and work place intervention.


Eligibility Criteria:
Inclusion Criteria:

* Employees on sick leave because of non-specific back and/or neck/shoulder pain
* actual unable to work and continuous or cumulative (totalized) work incapa- city in the past 6 monts
* ≥ 20 working days 100% absence from work or
* ≥ 40 working days 80 to 99% absence from work or
* ≥ 60 working days 50 to 79% absence from work and
* not older than 58 level of employment ≥ 50%
* no longer than 6 monts absencer from work (100% unable to work)

Exclusion Criteria:

* Specific diagnosis such as infection, neoplasm, metastasis osteoporosis, rheumatoid arthritis, fracture and inflammatory process or other conditions for which valid diagnoses had been demonstrated either in the anamnesis, records or the clinical examination
* Postoperative health condition with prohibited physical load
* Major co-morbidity which may determine return to work in a clearly stronger way then the MSD itself such as a major depression, psychosis, heavy drug or alcohol disease or instable cardiac or pulmonary disease
* Predominant specific shoulder pathology in "neck-shoulder pain"
Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the prostate
* Intermediate risk, organ-confined prostate cancer (T1a up to T2b) and voluntarily chooses Exablate, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy
* Up to 2 MRI visible Gleason 7 confirmed on mapping prostate biopsy that Investigator deems treatable within a single treatment session; may have secondary Gleason 6 on ipsilateral or contralateral side confirmed with biopsy and/or MRI
* PSA less than or equal to 20ng/mL

Exclusion Criteria:

* Evidence of distant prostate cancer including lymph node involvement and/or metastasis of cancer
* Subject undergoing androgen deprivation therapy, initiating any new medication that can affect PSA, or history of bilateral orchiectomy
* Active bladder cancer, active UTI, or untreated prostatitis
* Untreated urethral stricture/bladder neck contracture
* Prostate-specific chemotherapy, brachytherapy, cryotherapy, photodynamic therapy, radical prostatectomy, or focal therapy (excluding FUS); or any prior radiation therapy to the pelvis for prostate cancer or any other malignancy
* Subjects with pathology or implants that may adversely impact treatment due to acoustics, imaging, or safe probe insertion
* Subject not able or willing to tolerate the required prolonged stationary supine position during treatment
* Contraindications to MRI
A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible
* Measurable indicator metastases
* Age 18 years or older
* ECOG status 0-2
* An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea
* Hematocrit \> 29%, ANC \> 1500 cells/ul, platelets \> 100,000 cells/ul
* Serum creatinine within the laboratory's upper limit of normal
* Serum AST and ALT ≤ 1.5 x the laboratory's upper limit of normal
* Subject signed informed consent prior to subject entry

Exclusion Criteria:

* Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.
* Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.
* Subjects previously treated with DTIC or TMZ
* Symptomatic central nervous metastases
* Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.
* Confirmed diagnosis of hepatitis or HIV infection
* Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial
* Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy
* Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol
* Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment
* Subjects who have received amiodarone within 30 days of study drug administration
* History of hypersensitivity reaction to more than three (3) drugs or to mannitol
* Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1