cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

The purposes of this trial are:

* To study the efficacy of alendronate in HIV-associated osteoporosis
* To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant
* Non menopausal women
* Total femur BMD below -2.5 SD (T score) or lumbar spine BMD below -2.5 SD (T score) or BMD below -1 associated with a vertebral osteoporotic fracture (diminution of vertebral height over 20%)
* HIV infection known for at least 5 years
* CD4 cell count over 50/mm3
* Karnofsky score over or equal to 70
* Written informed consent.

Exclusion Criteria:

* Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria
* Testosterone below normal if treatment is hormonal
* BMI below or equal to 18
* Severe lung failure
* Chronic alcohol intoxication
* Ongoing opportunistic infection
* Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months
* History of treatment for osteoporosis
* History of malignancy in the previous 5 years (except skin cancer and Kaposi)
* Cytotoxic chemotherapy or cytokine therapy
* Liver cirrhosis
* Breast feeding
VST-1001 (Dilute Fluorescein) for Lymphatic Mapping & Localization of Lymph Nodes in Patients With Breast Cancer

The purpose of this Phase 1 portion of this clinical research study is to find out what dose of dilute fluorescein is needed for a surgeon to best see important lymph nodes that need to be removed during surgery (a standard of care surgery referred to as a Sentinel Lymph Node Biopsy procedure) in patients diagnosed with breast cancer.

The purpose of the Phase 2 portion of this clinical research study is to find out if giving dilute fluorescein sodium in combination with a radiotracer (a drug that is radioactive) can help surgeons localize the lymph nodes that need to be removed in patients diagnosed by breast cancer.

The study is a single center prospective, non randomized, single arm, open label, single dose VST-1001 study for lymphatic mapping and localization of lymph nodes draining a primary tumor site in patients with clinically node negative breast cancer.

This study evaluates the combined modality technique of investigational VST-1001 with companion medical devices (replacing the blue dye) and 99mTc-labeled sulfur colloid for concordance in lymphatic mapping and localization of lymph nodes in patients who are undergoing a sentinel lymph node biopsy (SLNB) surgical procedure.

This purpose of the Phase I study is to determine a safe and effective recommended dose of VST-1001 for intraoperative lymphatic mapping and localization of lymph nodes draining a breast tumor. The purpose of the Phase II study is to further evaluate the Phase I study recommended dose of VST-1001 and to evaluate its ability to provide intraoperative visualization of the lymphatic system and lymph nodes draining the primary tumor in patients diagnosed with breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary breast cancer.
* Diagnosed with invasive adenocarcinoma, or DCIS for which a SLNB is the recommended standard of care, or breast cancer with all of the following conditions met:

  * FNA results positive for cancer cells
  * positive clinical breast examination
  * mammography and/or US and/or MRI abnormality(ies) consistent with malignancy.
* N0 and M0 at the time of study entry.
* ECOG 0, 1, or 2

Exclusion Criteria:

* A tumor with direct extension to the chest wall and/or to the skin.
* Diffuse tumors or multiple malignant tumors in the breast.
* Prior breast malignancy of the ipsilateral breast.
* Patient currently receiving or had prior treatment for the currently diagnosed breast cancer.
* Medical conditions and/or prior surgical procedures that have the potential to substantially alter the lymphatic drainage pattern from the primary tumor to the lymph node basin.
* Inability to localize 1 or 2 lymph node drainage basin(s) via lymphatic mapping.
The Role of Affect Regulation and Self-presentation in the Expressive Writing Intervention

The purpose of the present study is twofold. First, we will attempt to examine the role that emotion regulation and self-presentation play as potential moderators in the expressive writing paradigm. We hypothesize that expressive writing participants who demonstrate greater abilities to regulate their emotions at baseline will improve more on our outcome measures. We also hypothesize that those expressive writing participants who demonstrate higher levels of self-presentation at baseline will improve less on our outcome measures.

The second aim of the study has two related objectives. First, we will attempt to investigate whether the expressive writing intervention can increase and enhance an individual's emotion regulation abilities. Related to this, we will then go on to examine whether emotion regulation can be looked at as a potential mechanism of action in the expressive writing procedure. Related to these two objectives, we hypothesize that in comparison to the control group, participants in the expressive writing condition will show increases in their ability to regulate their emotions from baseline to four week follow up. Moreover, we predict that greater gains in emotion regulation abilities for the expressive writing participants will be significantly related to greater gains in outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Previously experienced trauma (not current or ongoing; excluding bereavement)
* Currently experiencing trauma-related distress

Exclusion Criteria:

* Currently involved in psychotherapy
* Currently taking psychotropic medications
* Imminent threat to self or others
Remediation for Mild Cognitive Deficits After Cancer

Cancer survival rates have improved significantly over the past decades and patients now experience a number of side effects including cancer-related cognitive impairment (CRCI): problems with memory, executive function, attention, and difficulties performing two tasks at the same time. The frequency of CRCI in cancer patients is estimated to be between 10 to 40%, and more than 50% of patients describe difficulties in their daily life. These cognitive difficulties negatively impact the patient's quality of life as well as that of their family, and can also have negative consequences for their social and professional reintegration once cancer treatment is finished. Despite an increasing number of studies on CRCI, a standard of care for patients with CRCI after breast cancer is yet to be established. In the absence of clear directives, and in an attempt to respond to the increasing demand to provide care for breast cancer patients with CRCI, physical medicine and rehabilitation units in France have started providing day-hospital multidisciplinary interventions. The objective of this project is to use the single case experimental design method to investigate the efficacy of two such rehabilitation programs: a group-based program and a one-on-one program.


Eligibility Criteria:
Inclusion Criteria:

* Treated in the past for breast cancer with chemotherapy, surgery, and / or radiotherapy,
* Admitted as a day patient at the Henry Gabrielle Hospital or the Pontchaillou CHU Hospital during the study,
* Given free, informed consent in writing after being informed orally and in writing of the how the study will proceed.

Exclusion Criteria:

* Presence of another active cancer,
* Ongoing chemotherapy and/or radiotherapy treatment,
* Active progression of breast cancer,
* History of neurological or psychiatric conditions,
* Major disturbances in comprehension that prevent them giving free, informed consent,
* Pregnant, parturient or breastfeeding women,
* Person under a legal protection measure such as guardianship or curatorship,
* People not affiliated to a social security scheme (French Social Security) or beneficiaries of a similar scheme.
Detection of Early Swallowing Time by Electromyogram and Sound Recording in Healthy Volunteers

The objective of this study is to show the feasibility of detecting the specific activity of 2 muscles during swallowing using invasive sensors in healthy volunteers.

Total laryngectomy, which involves removing the larynx and performing a tracheostomy, is the standard method of surgical treatment for advanced laryngeal cancer.

It changes the patient's life and has an significant impact on his overall quality of life.

Over the last 10 years, numerous trials of artificial larynx implantation have been tested, but currently there is no method of implanting a system that detects the onset of a swallow.

The DEGLUTITION study aims to show the feasibility of detecting the specific activity of 2 muscles in swallowing using intramuscular electromyograms in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \< 25
* Affiliated with the social security plan or beneficiary of such a system
* Having signed the informed consent

Exclusion Criteria: subjects

* With chewing and/or swallowing disorders, or a history of chewing and/or swallowing disorders.
* With bleeding disorders (including patients on anticoagulants)
* With neurological disorders
* With a history of cervical surgery
* With immune deficiency
* Participating in an interventional study that may interfere with this study
* Protected person concerned by the articles L1121-5 to L1121-8 of the Public Health Code
Effects of Vestibular Habituation and Ocular Reflex Exercises on Vertigo

The aim of this study is to determine the comparative effects of vestibular Habituation and ocular reflex exercises on Gait stability, Dizziness severity, and fear of fall in elderly population with vertigo

vestibular habituation exercises focus on helping individual adapt to and reduce symptoms related to vestibular disorder such as improving balance , reducing dizziness and enhance overall functional abilities. ocular reflex exercises focus on improving eye movement control and coordination such as improving visual tracking , stability and Focus. This randomized clinical trial will be conducted at services hospital and Jinnah hospital for a duration of 10 months. The sample size will consist of 50 participants. 25 participants will be assigned to vestibular habituation exercise group and 25 to ocular reflex exercises group. Data will be collected using these assessment tools, including the dynamic gait index for gait stability, the fall efficacy scale for fear of fall, and dizziness handicap inventory for dizziness severity. Pre-intervention assessments will be conducted for all two groups. The effects of the interventions will be measured at baseline ,in the 3rd week ,post intervention, after 6 weeks, and at a 9th week follow up. Data analysis will be performed by using SPSS 26 software

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients
2. Age 65-75
3. patient with vestibular disorder for at least 6 months
4. patient with unspecific dizziness sensation for at least 3 months
5. Dizziness handicap inventory score \> 16 -

Exclusion Criteria:

1. patient with central nervous system diseases, like stroke, multiple sclerosis, Parkinson's disease.
2. orthopedic problems that precluded performance of the exercises
3. systemic diseases with no medication control
4. if patient were legally blind or had dementia
5. patient with no history of epilepsy and other neurological diseases -
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers

A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 under 45 years of age
* BMI state over 19 under 27

Exclusion Criteria:

* mean sit SBP≥100mmHg or mean sit DBP≥150mmHg at screening
* mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason
The Preventive Effect of Shenfu Injection on Myocardial Dysfunction in Sepsis

This study focuses on improving heart function in patients with life-threatening blood infections (septic shock). When the body fights severe infections, the heart sometimes struggles to pump blood effectively, which can lead to dangerous complications. Current treatments like intravenous fluids and blood pressure medications have limitations in protecting heart function.

This multicenter clinical trial aims to evaluate whether adding Shenfu Injection - a traditional Chinese medicine preparation widely used to enhance cardiac function in cardiovascular diseases - to standard therapies can:

1. Prevent myocardial dysfunction during septic shock
2. Accelerate cardiac recovery if complications occur
3. Improve overall survival and clinical outcomes The randomized controlled design will compare therapeutic effects between two groups: one receiving standard septic shock treatment alone, and the other receiving standard treatment combined with Shenfu Injection.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients clinically diagnosed with septic shock must meet the diagnostic criteria of Sepsis 3.0;
* 2. Age ≥ 18 years.

Exclusion Criteria:

* 1. Pregnant or breastfeeding women;
* 2. Individuals with a history of allergies or known hypersensitivity to Ginseng and Aconite Injection or its components;
* 3. Severe underlying diseases that may affect prognosis, including uncontrolled malignant tumors with multiple metastases that are unresectable, hematological disorders, cachexia, persistent active bleeding, severe malnutrition, HIV, etc.;
* 4. Severe cardiac conditions within the last three months, including acute unstable myocardial infarction, dilated cardiomyopathy, acute coronary syndrome, acute or chronic valvular heart disease, and congestive heart failure (New York Heart Association \[NYHA\] Class IV);
* 5. Any of the following medical procedures performed within the last three months: any form of cardiac surgery, thoracotomy, external cardiac compression, defibrillation, direct current cardioversion, or trauma;
* 6. Use of Ginseng and Aconite Injection for less than 48 hours;
* 7. Patients expected to die within 48 hours;
* 8. Patients deemed unsuitable for this study by the investigator.
Clinical Study 3MESPE Crowns

This clinical study seeks to address four independent questions that are all part of the delivery of care associated with the provision of a single item of treatment; an indirect restoration (known as a 'crown') to restore and cover a damaged tooth. The provision of a crown requires a series of sequential clinical and laboratory stages stages:

1. Stage 1 - Preliminary impression. Taking a pre-operative impression of the tooth to be crowned. This will be used to enable the fabrication of the temporary crown after the tooth has been prepared. This is standard care and follows established clinical protocols.
2. Stage 2 - Preparation of the tooth. This involves cutting the tooth back to make space for the crown that will be fabricated to replace the missing structure.
3. Stage 3 - Taking an impression of the prepared tooth. From this a duplicate model will be made to fabricate the crown. To take the impression, the dentist will need to gently push the gums away from the tooth by fractions of a millimeter so that the margins of the preparation are clearly discernible.
4. Stage 4 - Provision of a temporary restoration that will provide satisfactory function for a limited period of time, until the definitive crown can be fitted. This temporary crown is designed to have a finite short-term durability and have an ease of manufacture and subsequent removal; hence the use of a specific cement that will enable this.
5. Stage 5 - Fitting of the definitive restoration. This is designed to be a durable restoration, with a mean life expectancy measured in years, but which is ultimately determined by a number of clinical, biological and patient specific parameters. Definitive restorations are fitted with cement designed to retain the crown in permanent manner.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of at least one full-coverage posterior restoration (crown) in a permanent premolar or molar.
* If two teeth in opposing arches are in need of a full-coverage posterior restoration (crown) only the tooth or teeth in one arch will be included in the study.

Exclusion Criteria:

* Patients who are unable to give informed consent or vulnerable population as defined in ISO 14155 will not be enrolled.
* Patients with contraindications as described in the 'Instructions for Use' of the study materials
HB0034 in Patients With Generalized Pustular Psoriasis (GPP)

This is a study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients with generalized pustular psoriasis (GPP ).

This is an open-label, multicenter, phase Ib exploratory study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of HB0034 in adult patients presenting moderate-severe generalized pustular psoriasis (GPP ) flare.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, aged 18 to 75 years at screening
* A known and documented history of Generalized Pustular Psoriasis diagnosed with ERASPEN criteria
* Presenting with a moderate-severe flare of Generalized Pustular Psoriasis (GPP)
* Patients must be able to understand and sign a written informed consent document and complete study-related procedures and questionnaires.

Exclusion Criteria:

* Immediate life-threatening flare of Generalized Pustular Psoriasis or requiring intensive care treatment, according, to the judgment of the investigator. Life-threatening complications mainly include but are not limited to, cardiovascular/cytokine-driven shock, pulmonary distress
* History of clinically significant opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia)
* Pregnant or Breasting feeding subject. Women with a positive pregnancy test.
* Ongoing use of prohibited psoriasis treatments
* Further exclusions criteria apply
Pulmonary Rehabilitation in Asthmatic Patient

Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.

The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.

Eligibility Criteria:
Inclusion Criteria:

* between six and 18 years old
* asthma-diagnosed patients
* under medical treatment and disease control

Exclusion Criteria:

* fail to carry out the protocol evaluations
* interrupt the medical care and/or drug-based treatment
* acute lung infection or other chronic lung diseases
* other comorbidities (neuropathies, heart disease)
* missing in more than 20% the rehabilitation protocol
The Effect of Home-based Exercise on Functional Capacity of Covid-19 Survivor With Cardiovascular Comorbidity

Objective propose: to investigate the effect of home based breathing exercise and chest mobilization on the cardiorespiratory functional capacity of Covid-19 survivors with cardiovascular comorbidity.

Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. It is hypothesized that breathing exercise and chest mobilization in Covid-19 survivors will give benefits to Covid-19 survivors with cardiovascular disease.

Lung restrictive disorder is one of the reasons that induce chronic fatigue in COVID-19 (Corona Virus Disease-19) survivors. It also gives a significant effect on cardiovascular patients who are in the second phase of cardiac rehabilitation. Breathing exercise and chest mobilization are proven to increase lung functional capacity in Covid-19 survivors. On the other hand, there is still no research that shows the effectiveness of Breathing exercises and chest mobilization in Covid-19 survivors who are suffering from cardiovascular problems.

Patients in National Cardiac Center Hospital, Jakarta, with a history of Covid-19 and have cardiovascular disease are recruited. They will undergo pre and post-exercise examinations such as blood sampling, do 6 minutes walking test, Peak Cough Flow and Peak Flow Rate test, measuring the chest dimension, treadmill, and answer the European Quality of Life Five Dimension (EQ-5D) questions. With randomization, patients will be determined to treatment or control group. They will be prepared about what exercises should they do at home. Subjects will be supervised digitally and regularly through Zoom meetings. Exercises will be done for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients who got infected by Covid-19 in 3 months before recruitment and suffering cardiovascular disease
* Able to communicate and operate Youtube and Zoom.

Exclusion Criteria:

* Limitation to move any part of the body that causes the inability to do the instructed exercise.
* Feel pain in extremities (visual analog scale \>3)
* Chronic Obstructive Pulmonary Disease
* Neuromuscular disorder (stroke, peripheral neuropathy with significant motoric control disturbance
* Musculoskeletal disorder (fracture, post amputation, severe arthritis in support joints)