cyrilzakka/clinical-trials huggingface dataset:
129Xe Gas Exchange Imaging in IPF and cHP: A Reliability Study

This research is a study to test the reliability of Hyperpolarized Xenon MRI (HXe MRI) as a biomarker in interstitial lung disease. The study is a non-randomized study to evaluate the test-retest performance of HXe MRI in Idiopathic Pulmonary Fibrosis (IPF) and chronic Hypersensitivity Pneumonitis (cHP) as a non-invasive biomarker of disease severity and prognosis. The study will include approximately 15 subjects with IPF, 15 subjects with cHP and 10 sex and age-matched normal controls performed across 3 sites.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Diagnosis of progressive chronic HP, IPF as determined by MDD discussion (historical or during screening period) OR normal control (no history of known lung disease, no abnormal parenchymal or airway findings on CT examination and no values outside of the normal for FVC, FEV1, TLC, and DLCO.)
* FVC % Predicted \>45%
* DLCO % Predicted \>30%
* Progressive lung disease as defined by one of the following criteria within 24 months of screening visit
* Relative decline in the FVC ≥ 10% of the predicted value
* Relative decline in the FVC of ≥ 5% - \< 10% of the predicted value and worsening of respiratory symptoms
* Relative decline in the FVC of ≥ 5% - \< 10% of the predicted value and an increased extent of fibrosis on prior clinical high-resolution CT
* Worsening of respiratory symptoms and an increased extent of fibrosis on high-resolution CT.

Exclusion Criteria:

* Stable FVC over 2-year period as determined by study physician
* Unstable cardiac condition within 6 months of screening as determined by study physician
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis

The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.

This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study will be used in the study. The study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. The healthy volunteers are also included to study the safety of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
* Able and willing to comply with study visits and procedures specified in this protocol for at least six months period
* Able to understand and willing to sign and date the written informed consent form prior to admission of the study
* Able and willing to provide adequate information for locator purposes
* Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation

Exclusion Criteria:

* Pregnant women
* Over-weighted
* Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
* Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
* Unable to spend 3 hours for treatment at the study center
The COPD Patient Management European Trial (COMET)

The goal of the study is to evaluate a Home-Based Disease Management program specifically developed for patients with Gold III/IV COPD.

By improving disease knowledge, awareness of significant clinical deterioration and self-management skills for patients, this Home-Based COPD Management Program is expected to reduce the severity of exacerbations, the need for emergency hospitalisations, thus demonstrating the efficacy and the cost effectiveness of this intervention.

Primary objective: To evaluate a strategy of Chronic Obstructive Pulmonary Disease (COPD) management to reduce the number of hospital days in patients with severe Gold III/IV COPD: a Home-Based COPD Management Program versus usual patient education and follow-up.

Secondary objectives:

* To assess the clinical outcome and the health-related quality of life,
* To assess safety,
* To evaluate medico-economic impact.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed Gold III/IV COPD
* Current or ex-smoker with a smoking history ≥ 10 pack-years
* At least one COPD exacerbation leading to hospitalization in the year before selection.

Exclusion Criteria:

* LTOT for another reason than COPD
* Severe concomitant disorder associated with a limited probability of survival (\< 6 months)
* Tracheostomy
* Long term oral corticosteroids therapy
Testing CBT Models and Change Mechanisms for Alcohol Dependent Women

The study has 4 specific aims: (1) To modify our existing Individual Female Specific Cognitive Behavioral Therapy (I-FS-CBT) for Alcohol Use Disorder (AUD) approach to treat women with alcohol dependence in a group format, Group Female Specific Cognitive Behavioral Therapy (G-FS-CBT); (2) To test the relative efficacy of I-FS-CBT and G-FS-CBT; (3) To test hypothesized mechanisms of change in drinking that are common to both treatments, including (a) coping skills and enhanced self-efficacy for abstinence; (b) enhanced sense of autonomy; (c) alleviation of negative affect, and (d) increased social network support for abstinence, and (4) To assess the relative cost-effectiveness of the individual and group treatment.

Participants completed a telephone screen for initial eligibility and were scheduled for an in-person clinical intake interview. Consented women were scheduled for a baseline research interview (BL) approximately one week later. At the end of the BL, participants were randomized to treatment condition. During the 12 session treatment period, women completed assessments at the beginning and end of each therapy session on secondary outcome and therapy process variables.

In I-FS-CBT each participant saw a therapist weekly. The first session was 90 minutes long, and subsequent sessions were 60 minutes long. The I-FS-CBT manual included core CBT, motivational enhancement, and relapse prevention components. Two core thematic women's issues were integrated into each session via discussion and illustrative material: (a) self-confidence and (b) self-care.

The G-FS-CBT manual included material identical to I-FS-CBT, but the session organization was modified for a closed group format. The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material, and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence. The first session of G-FS-CBT was 2 hours; remaining sessions were 90 minutes.

In-person follow-up interviews were done at 3, 9, and 15 months post-session 1.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* have a current (past year) Diagnostic and Statistical Manual-IV (DSM-IV) alcohol dependence diagnosis
* used alcohol in the 60 days prior to telephone screening

Exclusion Criteria:

* have psychotic symptoms in the past six months
* gross cognitive impairment
* current physiological dependence on any illicit drug
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants

The primary aim of the study is to show that NeisVac-C does not influence the seroconversion rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP) vaccines in infants.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers infants, aged 2 to 6 months
* Clinically healthy, (i.e. the physician would have no reservations vaccinating with a meningococcal C vaccine outside the scope of a clinical trial)
* Parent(s)/legal guardian understands the study and has provided written informed consent for his/her infant's study participation
* Parent(s)/legal guardian and infant will be available for the duration of the study

Exclusion Criteria:

* History of any vaccine-related contraindicating event (e.g. anaphylaxis)
* Rash or other dermatological condition at the injection site which could interfere with injection site reaction monitoring or lead to a dermatological reaction
* Subjects who have received or will receive other vaccine(s) ± 30 days before or after the study period
* Concurrent participation in or previous participation in a clinical trial with an investigational medicinal product
* Subjects who suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions
* Subjects who have previously received a vaccination against Hep B or meningococcal C
* Subjects who have received banked human blood or immunoglobulins within one month of study entry
Effect of 12 Weeks of Resistive Exercises Versus Aerobic Exercises in Overweight Hypertensive Postmenopausal Women

Sixty postmenopausal women participated in this study from gynecological outpatient clinic, at Al-Zahra universal Hospital, Al Azhar University, and Cairo. They were first diagnosed to be hypertensive in their early postmenopausal period .Their blood pressure ranged between 140/90mmHg to 170/105mmHg, their ages ranged from 50 to 60 years and their body mass index ranged from 30:35 kg/m2.

The participants were divided randomly according to closed envelop into three equal groups in number: Group A (RE) consisted of twenty women who participated in the resistive exercise program. Group B (AE) group: consisted of twenty women who participated in an aerobic exercise program. All patients in both groups (A \& B) participated in the exercises three times per week for twelve weeks and every session lasted for 45 min and continues their antihypertensive medication

Eligibility Criteria:
Inclusion Criteria:

* All women diagnosed as essential hypertension.
* All women must be in their early postmenopausal period

Exclusion Criteria:

* Lesion to higher centers leading to hypertension (embolism)
* any cardiovascular disease
* premature menopause
* surgical menopause
* severe hypertension
* diabetic
* under treatment of hormonal therapy.
Disorders of Sex Development (DSD) 46.XY in Three Siblings

This is a case series of three siblings with DSD 46,XY with relevant discussion

This is a case series of three sisters with DSD 46 X,Y. Three sisters, aged nineteen, seventeen, and fifteen years old came with an identical complaint of late menarche. Physical examinations, lab results and karyotypes were performed.

Eligibility Criteria:
Inclusion Criteria:

* 3 female siblings with identical complaints of no menarche

Exclusion Criteria:

* patients outside this family.
MPS (RaDiCo Cohort) (RaDiCo-MPS)

The goal of this observational study is to characterize the epidemiology and natural history of MPS diseases by building a retrospective and prospective collection of extensive phenotypic data from French MPS patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MPS based on clinically relevant enzyme deficiency, with abnormally elevated GAG urinary excretion and/or identification of pathogenic mutations.
* Signed informed consent or parents/guardian non-opposition for deceased patients (minor or protected major)

There are no non-inclusion criteria.
Study to Assess the Efficacy and Safety of MT-3921 in Subjects With Acute Traumatic Cervical Spinal Cord Injury

The purpose of this study is to compare the efficacy and safety of intravenous (IV) infusions of MT-3921 to placebo in subjects with acute traumatic cervical spinal cord injury.

Subjects meeting eligibility criteria will enter the 6-month double-blind period. Subjects will be randomized in a 2:1 ratio to receive MT-3921 or placebo in a double blind manner.


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Provide written informed consent prior to beginning any study procedures
* Cervical spinal cord injury that meet all of the following criteria:

  * Classified as AIS A, AIS B or AIS C
  * ISNCSCI neurological level of injury between C4 and C7 (for C4, the subject must have at least 1 point of motor activity between C5 to C7)
  * UEMS ≤28 at Screening
* Body mass index (BMI) \<40

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* Any concomitant injury that interferes with the procedures and examinations required by study protocol, including performance, interpretation or validity of neurological examinations
* Poly-traumatic Injury as defined by Injury Severity Score (ISS) values \> 25
* Penetrating spinal cord injuries
* Complete transection of the spinal cord
* Any other significant pre-existing medical conditions prior to spinal cord injury or current conditions that, in the judgement of the iInvestigator, may increase the risks associated with study participation
* History of anaphylaxis or clinically significant allergic reactions to any medication
* History or presence of malignancy within the last 3 years prior to screening
* Subjects with current SARS-CoV-2 infection (COVID-19)
* Subjects with hereditary fructose intolerance
* Psychoactive substance use disorder
* Participation in any clinical trial of a new chemical entity within 12 weeks prior to Screening
* Female subjects who are pregnant or lactating
Gout Self-Monitoring Aiming to Reach Target

This study evaluates whether a supported self-management approach to gout is able to achieve target levels of serum urate, and better control of gout flares.

Gout is the most common cause of inflammatory arthritis with recurrent gout flares a cause of reduced quality of life, work absence and disability. Effective treatments are widely available and yet many patients never achieve control of their disease. Resolution of gout attacks requires sustained lowering of the levels of serum urate, which in practise is seldom achieved. A supported self-management approach to gout has been developed which incorporates self-testing of urate levels and a smartphone application that will prompt participants to self-test and allow clinical researchers to titrate urate lowering therapies.

The feasibility of this approach will be evaluated in patients with gout referred to secondary care. Participants will be randomised 2:1 to the intervention or a control group. The intervention group will be offered supported self-management incorporating self-testing of serum urate. The control group will receive usual care from their primary care physician. The primary outcome will be the proportion of patients achieving levels of serum urate at or below 0.3mmol/l by 6 months. Participants will be followed up for a total of 12 months to assess the broader health and economic impact of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of gout (as per American College of Rheumatology criteria)
* Physician recommendation that escalation of urate lowering therapy with allopurinol or febuxostat is appropriate.
* Serum urate \>0.36mm/L.
* Patient has a mobile phone and is able to install GoutSMART (Gout Self-monitoring Aiming to Reach Target urate) application.

Exclusion Criteria:

* Subject is unable to provide consent
* Severe renal failure (eGFR \<30) or established liver disease
* Previous adverse reaction to allopurinol or febuxostat
Mesenchymal Stem Cells for Radiation-induced Xerostomia

A prospective study for long-term follow-up (LTFU) to evaluate safety and efficacy in subjects who participated in the Phase 1/2 randomized placebo-controlled trial MESRIX.

This is a LTFU study to assess the long-term and late effects of treatment with MSCs or placebo given ultrasound-guided into the submandibular glands in subjects participating in the MESRIX trial. Study participants from the MESRIX trial will be invited for a clinical visit. The visit will include medical history, an ENT examination; measurements of the saliva production by sialometry, a Magnetic resonance imaging scan (MRI) and obtaining data on the patient-reported outcome with Xerostomia Questionnaire (XQ) and Visual-Analogue-Symptomatic scale (VAS). Subjects, who are not able or willing to attend a clinical visit, will be encouraged to fill out the Questionnaires online or on paper. If a study participant has deceased, information of the cause of death will be investigated in The Danish Register of Causes of Death

Eligibility Criteria:
Inclusion Criteria:

1. Assessment of safety and treatment efficacy in subjects who were enrolled in the MESRIX Phase I/II clinical trial
2. Subjects who were treated with either autologous mesenchymal stem cells or placebo
3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the trial

Exclusion Criteria:

1. Subjects who were not enrolled in the MESRIX trial
Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles

The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* age \< 75 years with histologically proven adenocarcinoma of the colon or rectum
* no severe major organ dysfunction
* WHO performance status of 0 or 1
* Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system)

Exclusion Criteria:

* age \>= 75
* severe major organ dysfunction
* WHO performance status of \>1
* Stage I or Stage IV
Calculating Blood Volume by Dilution of Hemoglobin - Pilot Study

Although blood volume is such an important parameter in everyday clinical medicine it cannot be measured easily. As a matter of fact, it is almost never measured but estimated or calculated based upon numbers derived from mostly healthy patients.

The investigators do not even know whether someone's normal - i.e. before a surgery - blood volume is actually anywhere close to the generally accepted estimate or calculation.

Tests exist in which a substance of known concentration is diluted in a person's blood volume and the resulting concentration is then measured, which allows the blood volume to be calculated. However, none of these tests can be completed at the bedside since they are not fast and require considerable set-up.

This study turns the above approach upside-down: we will dilute the blood slightly with a known small volume of an intravenous fluid commonly used in many clinical settings and measure the concentra-tion of hemoglobin - the oxygen carrier contained in red blood cells - before and after adding the fluid. That allows for similar calculations without using neither specialized substances nor equipment.

Hemoglobin is routinely measured in laboratories and is often a routine test before and during surg-eries and in intensive care units.

Devices that can measure hemoglobin through the skin without actually drawing any blood are avail-able. If found comparable to laboratory determination of hemoglobin they could provide for a bedside and almost real-time assessment of blood volume, something that could be extremely valuable for de-cision making in critical areas of medicine and promoting goal directed therapies.


Eligibility Criteria:
Inclusion Criteria:

* healthy adults of normal constitution (weight/height)

Exclusion Criteria:

* any ongoing or recent infusions (\< 24h ago) of any fluid/substance
* morbid obesity
* heart disease
* hypertension
* coagulopathy (bleeding disorder)
* therapy with anti- or procoagulants
* transfusion of any blood product
* therapy with diuretics
* therapy with vasopressors
* vasodilators or inotropes
* acute or chronic infections
* immunocompromised status
* hemodynamically unstable
* hemorrhage (bleeding)
* recent surgery
* pregnancy
* younger than 18 years old
Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation

The current evidences indicate that \~30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* sick sinus syndrome with pacemaker Class I or Class IIa indication
* has a pacemaker which can provide the daily AF burden monitor record for at least 28 days
* has at AF record in the past 6 months, the valid AF record includes any of

  1. at least one 30 seconds AF holter record
  2. at least one 15 seconds 12-ECG record
  3. at least 5 minutes long AF episodes record from pacemakers
* able and willing to give informed consent

Exclusion Criteria:

* will have cardiac surgery in the next 6 month or in the waiting list of heart transplantation
* NYHA Class III or IV
* LVEF \<50%
* Reversible AF, such as AF caused by hyperthyroidism or severe postoperative atrial fibrillation
* Persistence AF
* Expected life expectancy less than 1 year
* Planned to be pregnant or be in the feeding period in the next year
* Non-stable, decompensated heart failure
* Allergy to Amiodarone, Propafenone or Sotalol
* Cancer
* Clear liver damage ( ALT and/or AST \> 2\*normal limit)
* Patients with cardiogenic shock history
* Be in the treatment of Amiodarone for more than 3 months or less than 3 months with Amiodarone wash out period less than 30 days
* Coronary artery disease (CHD), cardiomyopathy, severe valvular heart disease, severe obstructive pulmonary disease (COPD), long QT syndrome
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer

The purpose of this study is to assess the detection rate and false negative rate of sentinel lymph node biopsy following previous surgical biopsy for early breast cancer diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Previous conservative surgical biopsy
* Secondary pathological diagnosis of infiltrative cancer
* No clinically involved axillary node (N0)
* No previous neoadjuvant treatment
* Performance status European Cancer Conference (ECCO) Grade ≤ 1
* Patient's written informed consent to participate in the study according to French law
* Surgeon must have performed its learning curve

Exclusion Criteria:

* Lack of infiltrative breast carcinoma (in situ) pT4d \> N0
* Breast cancer relapse
* Pregnancy
* Known patent blue allergy
* Indication for radical or partial mastectomy
* Patient unable to understand the trial