cyrilzakka/clinical-trials huggingface dataset:
Treatment Adherence of Home Parenteral Nutrition in Patients With Chronic Intestinal Failure. (QANPIC)

This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.

Chronic intestinal failure (CIF) is a chronic disease and its main treatment is home parenteral nutrition. This disease is defined by a small bowel dysfunction preventing absorption of nutrients and water inputs. A " normal " oral diet is then insufficient, and must be supplied by an " artificial " parenteral nutrition. This treatment is administered at home, by a central veinous catheter, with varying volumes and frequencies.

The quality of life of patients treated by home parenteral nutrition is significatively altered .

The constraints linked to this treatment may make it difficult to follow. The patients can be lead to ask their doctor for a relief or a modification of this treatment during office visits, to improve their quality of life.

Poor treatment adherence concerns 25% of patients with chronic disease . It has never been assessed in France in CIF.

The goal of this study is to evaluate the treatment adherence for home parenteral nutrition in two of its components: negotiation during office visits, and compliance at home.

The negociation component will be assessed during an office visit with the help of forms, by the difference between " ideal " parenteral nutrition prescription proposed by prescriber and the " final " prescription, that the patient ultimately receives at the end of the office visit.

The compliance component will be assessed by a telephone interview, 8 weeks after the office visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Diagnosis of CIF (insufficiency of intestinal absorptive, motor or vascular functions that require parenteral nutrition).
* Home parenteral nutrition treatment for at least 6 months.
* With home parenteral nutrition treatment stable for at least 3 months.
* Agreeing to participate in research protocol.

Exclusion Criteria:

* Any condition that does not let a telephone interview (example : deafness, severe neurocognitive impairment).
Study To Assess Effectiveness and Adverse Events of Foscarbidopa/ Foslevodopa in Adult Participants With Advanced Parkinson Disease in Real Life Setting

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective foscarbidopa/ foslevodopa is in treating French adult participants with advanced Parkinson disease under routine clinical practice.

Foslevodopa/foscarbidopa is an approved drug outside of US for the treatment of Parkinson's Disease. Approximately 200 adult participants who are prescribed foslevodopa/foscarbidopa by their doctors will be enrolled across approximately 30 sites in France.

Participants will receive foscarbidopa/ foslevodopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 12 months.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants with advanced Parkinson disease with motor complications insufficiently controlled by current therapy
* Participants eligible for foscarbidopa / foslevodopa according to French label \& regulation.
* Treatment initiation decision prior to and independently from study enrolment

Exclusion Criteria:

* Participants with any contraindication to foscarbidopa / foslevodopa.
* Participants with Mini mental state examination (MMSE) score \< 24
Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2

The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument.

The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test:

1. shows sensitivity:

   * ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or
   * ≥ 90% for subjects with Ct ≤ 25.
2. show ≥ 98% specificity.


Eligibility Criteria:
Inclusion Criteria:

* provide valid informed consent before taking the tests;
* in the case of symptomatic patients, be tested within the first seven days after the onset of symptoms.
* Male or female, aged equal to or older than 18 years of age.

Exclusion Criteria:

* Symptomatic participants who take the test after seven days after the onset of symptoms are excluded from the study
Pain in Cancer Survivors

The purpose of this study is to find out about the pain and quality of life of individuals who are adult cancer survivors. By quality of life, we mean how you are feeling about different aspects of your life, including your physical health, your emotional health, and your ability to carry out daily activities. We are interested in people's opinions about their quality of life, as well as the factors that affect their quality of life. In addition, learning about pain will help us to develop new services for adult cancer survivors.

The main objective of the proposed study is to identify the prevalence of persistent pain in a sample of adult cancer survivors. Currently, there is a lack of comprehensive information about pain in the cancer survivor population. Although prior studies have assessed pain syndromes in breast and lung cancer survivors (e.g., post-mastectomy and post-thoracotomy pain), there is a lack of information about the prevalence and characteristics of post-treatment pain in other subpopulations of survivors. To address this knowledge gap, a random sample of cancer survivors who are from 1 to 10 years post-treatment completion and who were treated at Memorial Sloan-Kettering Cancer Center will complete a telephone-administered pain interview and assessment battery focusing on pain, quality of life, and psychological distress. Our initial recruitment and evaluation will begin in 50 breast cancer survivors and then will expand 50 survivors in each of the other services Colorectal, Genitourinary, Head and Neck, and Thoracic in allotments of 50 participants each. We estimate that the completion time for the interview and assessment battery will range from 45 to 60 minutes. This telephone-based survey will identify vulnerable subgroups of patients with persistent pain and provide a knowledge base for future research on the prevalence and risk factors for post-treatment pain in the cancer survivor population.

Eligibility Criteria:
Inclusion Criteria:

* Cancer treatment at MSKCC
* Are from 1 to 10 years post-treatment completion at the time of study recruitment
* No evidence of disease (NED) at the time of assessment;
* Over 18 years of age
* Can be reached by telephone
* Able to provide informed consent
* Able to speak and read English
* Cancer survivors who received adjuvant therapies outside MSKCC will be asked to self-report the type and duration of cancer treatments received.

Exclusion Criteria:

* Undergoing active cancer treatment (ongoing tamoxifen use, hormone replacement therapy or use of biologics are permitted)
* Evidence of encephalopathy, psychotic illness or cognitive impairment severe enough to preclude giving informed consent to the study staff, or completing the survey instruments of the study.
Change Your Life With Seven Sheets of Paper

The aim of this study is to deliver CBT based intervention called "Change your life with 7 Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained traditional birth attendants (TBAs). Participants will be recruited from low income area in Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers having children between birth till 12 months. Group intervention will be delivered through trained TBAs.

The prevalence rate of PND in Pakistani women and its effect on the growth and development of young children and child mortality is very high. Despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals . Therefore the aim of this study is to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called "Changing your life with seven sheets of paper". Participants will be recruited from low income area in Karachi. Total 36 participants will be recruited and randomized into 2 groups; intervention and Treatment As Usual (TAU) group. Total 8 sessions will be delivered by trained TBAs over the period of 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with a child between 0-12 months
* Women who score 14 or above on Edinburgh Postnatal Depression scale (EPDS)
* Age range between 18 to 45 years
* Women able to provide written informed consent.

Exclusion Criteria:

* Severe depression or any other major psychiatric disorder
* Severe suicidal ideation
* Currently receiving any psychiatric or psychological treatment
* Intellectual disability in mother
* Chronic medical condition
* Having children with intellectual or physical disability
Prospective Pilot Study Identifying Clinically Relevant Biological Targets for Medical Therapy

New data suggests that the current treatment for pediatric adamantinomatous craniopharyngioma (CPA) may not be as effective as it could be.

Current treatment regimens for pediatric CPA are limited to surgery and radiation therapy. This pilot study seeks to identify biologically rational therapeutics for the medical treatment of adamantinomatous CPA by confirming the overexpression of specific molecules.

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 0-21 years of age.
2. Patients with the diagnosis or clinical suspicion of craniopharyngioma in whom planned clinical management will include tissue sampling.

Exclusion Criteria:

1. Patients in whom final pathology does not demonstrate adamantinomatous craniopharyngioma
2. Patients in whom tissue specimen is not obtained/available
3. Patients over 21 years of age.
4. Patients who choose not to participate
Remote Orthophonic Follow-up on Patients with Chronic Swallowing Disorders

The study will assess the feasibility of monthly post rehabilitation remote monitoring, using the "MAX Educ" webvision app, in patients with sequelae of aerodigestive cancer treatments.

The patients included in the study will benefit from a monthly video follow-up via the WEB tool "MAX Educ" during the first 6 months of their discharge from the rehabilitation center. They will be contacted each month during 5 months by the CRIL speech therapist for an interview (20 to 30 minutes).

The interview will take place in 2 stages; at first, a discussion phase, during which the speech therapist will take simple news of the patient. The second phase, more formal, will be the opportunity to collect the data necessary for the validation of the secondary endpoints. To do this, the speech therapist will use the Deglutition Handicap Index (DHI) and an interview grid.

The interview will be conducted using an interview sheet previously written by the project team. The following elements will be discussed: the perceived swallowing handicap (DHI), the instructions related to diet and their daily application, ongoing rehabilitation follow-ups, notable events as well as his psycho-emotional experience in relation to said disorders.

After signing the consent and verifying the eligibility criteria, all patients will be assessed upon discharge from the rehabilitation center by means of video swallowing fluoroscopy, allowing the deglutition score to be established.

EORTC Quality of Life Questionnaire (QLQ) QLQ-30 and its annex H \& N35 and the DHI will also be completed at the inclusion visit at T0.

They will then be monitored monthly by video from Month 1 to Month 5.

During the end of research visit at 6 months, all the patients included will be reviewed in follow-up consultation with a doctor and a speech therapist within the intensive rehabilitation center for laryngectomees (which corresponds to the standard follow-up) and evaluated by video swallowing fluoroscopy. EORTC QLQ-30, EORTC QLQ-H \& N35 quality of life questionnaires and the DHI will also have to be completed.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 or over and treated for cancer of the upper aero-digestive tract:
* Patient having spent a stay at the intensive rehabilitation center for laryngectomees
* Patient with a medical diagnosis of swallowing disorders at risk of inhalation
* Patient having the possibility of accessing a device allowing the use of the software by video (smartphone, tablet and / or computer)
* Informed consent signed by the patient.
* Patient affiliated to a social security scheme or equivalent

Exclusion Criteria:

* Progressive neurological disease leading to cognitive disorders
* Patient with guardianship, curators or legal protection
* Inability to give consent
* Patient participating in another research including an exclusion period still in progress
* Patient with speech therapy whose frequency is greater than 1 weekly session
Prenatal Aspirin and Postpartum Vascular Function

Preeclampsia is a pregnancy disorder affecting \~5-10% of pregnancies in the United States. Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. Low dose aspirin (LDA; 75-150mg/daily) is currently the most effective and clinically accepted therapy for reducing preeclampsia prevalence in women at high risk for developing the syndrome. The purpose of this study is to interrogate the mechanisms by which LDA therapy mitigates persistent vascular dysfunction in postpartum women who have had preeclampsia.

In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had a history of preeclampsia. As a compliment to these measurements, they also draw blood from the subjects and isolate the inflammatory cells.


Eligibility Criteria:
Inclusion:

* 18 years or older,
* 12 weeks to 5 years postpartum
* and one of the following:

  1. women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy,
  2. women who had a normal pregnancy and used LDA during pregnancy,
  3. women who had preeclampsia and did not use LDA during pregnancy,
  4. women who had preeclampsia and used LDA during pregnancy.

Exclusion:

* current daily aspirin use,
* skin diseases,
* current tobacco use,
* diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of hypertension prior to pregnancy,
* history of gestational diabetes,
* current pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex),
* known allergies to study drugs.
Respiratory Muscle Training in L-Onset Pompe Disease (LOPD)

This study is being done to test the effects of respiratory muscle training (RMT) in patients with late-onset Pompe Disease (LOPD) who have weakness of their breathing muscles. The results of this study will help design future research studies about RMT in LOPD. The goals of this study are to decide if sham-RMT is a useful control condition for RMT and to choose the best ways to measure the health benefits of RMT in LOPD.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of LOPD
* On enzyme replacement therapy for ≥ 26 weeks at pretest
* Able to follow directions for study participation
* Able to complete a home-based RMT regimen

Exclusion Criteria:

* Neurodegenerative conditions (e.g. stroke, dementia) or other serious neurologic condition that would prevent meaningful study participation as determined at the discretion of the principle investigator
* Inability to give legally effective consent
* Inability to read and understand English
DAA Treatment in Donor HCV-positive to Recipient HCV-negative Liver Transplant

This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Patients will be selected based on diminished likelihood of receiving a liver from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.

Eligibility Criteria:
Inclusion Criteria:

* Recipient is Age ≥ 18 years
* Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
* HCV naïve
* Able to sign informed consent

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Human immunodeficiency virus (HIV) positivity
* Need for dual organ transplant
* Any contra-indication to liver transplantation per center protocol
Comparison of Instillation and Packing in Mydriasis for Premature Infants

The purpose of this study is to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

Adequate pupil dilatation was needed for screening and treatment of retinopathy of prematurity (ROP) in premature infants.In general clinical practice, mydriatic drugs were instilled many times until the pupil reached the maximum size. However, poor mydriasis were found in many eyes despite maximum instillation was used. From the clinical observation, we found the packing of mydriatic drugs in lower conjunctival fornix was much more effective to dilate the pupil than instillation in some patients. The purpose of this study was to compare the mydriatic effect of 2.5% phenylephrine and 1% tropicamide by conventional instillation and lower conjunctival fornix packing in premature infants.

Eligibility Criteria:
Inclusion Criteria:

* gestational age of less than 32 weeks and/or the birth weight of less than 1,500 grams
* stable clinical course

Exclusion Criteria:

* history of intraocular surgery or laser treatment
* previous eyedrop instillation that might affect the pupil size
* severe underlying disease or unstable clinical course that mydriatic drugs or the examination could aggravate their conditions
Effects of Short Foot Exercise on Knee Pain, Muscle Tone, Balance, and Quality of Life in Flexible Flatfoot Patients

This study was a clinical trial to investigate the effects of Short Foot Exercise (SFE) and standard physical therapy on knee muscle tone, knee pain and function, balance ability, and quality of life in adults with flexible flat feet and knee pain.

This study aims to determine whether strengthening foot intrinsic muscles through SFE can reduce knee pain, improve muscle function, enhance balance, and improve quality of life in individuals with flexible flatfoot. Results may provide evidence-based rehabilitation strategies for managing knee pain in these patients.

Eligibility Criteria:
Inclusion Criteria:

* BMI (Body Mass Index): If between 18 and 25 kg/m²
* Litigation period: If knee pain lasted for more than 6 weeks
* Navicular drop test: If it was 10 mm or more
* Numerical assessment scale: If knee pain was 4 or more
* Health status: If you are a person without health problems and are trying to participate in the experiment

Exclusion Criteria:

* History of knee surgery: If you have had knee surgery
* Treatment history: If you have received physical therapy for knee pain in the 4 weeks before the start of the study
* Mental status: If you have a psychological disorder that may interfere with your participation in the study
* Injury status: If you have a current serious injury affecting the lower extremity joints and foot
* Lower extremity alignment abnormalities and specific conditions: If you have structural flat foot, scoliosis
* Diseases and other conditions: If you have diabetes, rheumatoid arthritis, or menopause
* Neurological disorders: If you have experienced a neurological disorder within the past 6 months
Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

The study is designed to assess the efficacy of an investigational drug called SR121463B (vasopressin receptor antagonist) in the treatment of low levels of sodium in the blood associated with the Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH).

This double blind period study is followed by 2 open label extension studies with flexible doses of satavaptan.

This is a multicenter worldwide study with 32 participating men and women aimed to figure out whether SR121463B is safe and effective in correcting low levels of sodium in blood in subjects with SIADH. The participation in the study lasts up to 34 days. After screening, during the first part of the study (maximum 5 days), the subjects receive either capsules of SR121463B or a matching placebo. During the second part of the study (23 days), subjects receive either capsules of SR121463B or no treatment. The subjects will be assessed by physical examinations, electrocardiograms, blood samplings, and urine collections. Women of childbearing potential must have an approved method of contraception.

Eligibility Criteria:
SIADH of any origin