cyrilzakka/clinical-trials huggingface dataset:
Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.

The purpose of this study is to determine wich treatment is the most effective in prevention of glucocorticoid-induced osteoporosis in patients with rheumatic diseases. The STOP-study: a randomized placebo controlled trial with alendronate versus alfacalcidol.

Treatment with glucocorticoids (GCs) is associated with bone loss initiated already early in therapy, causing increased (vertebral) fracture risk. Bone loss is caused by inhibition of bone formation by GCs. Active vitamin D analogues like alfacalcidol directly stimulate osteoblasts leading to an increase in bone formation. Bisphosphonates like alendronate induce apoptosis of osteoclasts leading to inhibition of bone resorption.

We performed a randomized, double-placebo, double-blind clinical trial of 18 months duration in patients with a rheumatic disease, starting GCs in a dosage of 7.5 mg prednisone equivalent daily or higher. Two hundred one patients were allocated to receive either alendronate 10 mg and alfacalcidol-placebo daily or alfacalcidol 1 microgram and alendronate-placebo daily. Primary outcome was change in bone mineral density of the lumbar spine in 18 months, secondary outcome incidence of (symptomatic) morphometric vertebral deformities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a rheumatic disease.
* Starting treatment with glucocorticoids in a dosage of 7.5 mg prednisone equivalent daily or higher.
* All ethnic groups and races.

Exclusion Criteria:

* Glucocorticoid treatment in the past 12 months (except for 12 weeks preceding the study)
* Primary hyperparathyroidism, hyperthyroidism or hypothyroidism in last year
* Metabolic bone disease
* Creatinine clearance of \< 50 ml/min
* Documented hypercalcemia or hypercalciuria, nephrolithiasis in the last 5 years
* Pregnancy or lactation
* Treatment in the last 12 months with hormone-replacement therapy
* Anabolic steroids, calcitonin, active vitamin D3 analogues, fluoride or bisphosphonates.
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain

Persistent postsurgical abdominal pain (PPAP) is a very difficult to treat pain. This pain can persist for months or even years and significantly diminishes quality of life. The exact underlying cause for this pain persistence is still unclear, which makes its treatment still a challenge. The promising analgesic effects of Δ9-THC in previous research, plus the improved bioavailability of Namisol® in comparison with previous Δ9-THC substances form the basis of the present research proposal.

The current study aims to investigate the analgesic efficacy of Namisol® as add-on analgesic during a long-term treatment (52 days) of persistent postsurgical abdominal pain.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Pain should have developed after a surgical procedure
* Pain duration exceeding 3 months, and average NRS≥3
* Stable doses intake of analgesics for the past 2 months
* The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

* Diagnosed irritated bowel syndrome (IBS) or chronic pancreatitis
* Patient took cannabinoids on a regular basis for at least one year
* Patient does not feel a pinprick test in the lower extremities
* Patient has a body mass index (BMI) above 36,0 kg/m2
* Patient suffers from serious painful conditions other than chronic pancreatitis
* Patient has a significant medical disorder that may interfere with the study or may pose a risk for the patient
* Patient uses any kind of concomitant medication that may interfere with the study or may pose a risk for the patient
* Patient does not tolerate oral intake of medication or liquids, or is refrained from oral intake because of medical reasons
* Patient demonstrates clinical relevant deviations in the electrocardiogram (ECG)
* Patient has an actual moderate to severe renal impairment
* Patient has an actual moderate to severe hepatic impairment
* Patient has a presence or history of major psychiatric illness
* Patient has experienced an epileptic seizure in the past
* Patient demonstrates clinically significant laboratory abnormalities
* Patient demonstrates a positive urine drug screen for THC, cocaine, MDMA, and amphetamines
* Patient demonstrates a positive test result on hepatitis B surface antigen, hepatitis C antibody or HIV antibody test
* Patient has a history of sensitivity / idiosyncrasy to THC
* Patient has a known or suspected lactose intolerance
* Female patient is pregnant or breastfeeding
* Patient intends to conceive a child during the course of the study
* Patient participates in another investigational drug study
* Patient has a clinical significant exacerbation in illness
* Patient is unwilling or unable to comply with the lifestyle guidelines
The Effect Of Tafamidis For The Transthyretin Amyloid Polyneuropathy Patients With V30M Or Non-V30M Transthyretin

Tafamidis has been developed as an oral specific stabilizer of transthyretin tetramer.


Eligibility Criteria:
Inclusion Criteria:

* Transthyretin amyloid polyneuropathy with V30M or non-V30M transthyretin mutation.
* Subject had amyloid documented by biopsy in accordance with institutional site standard of care.

Exclusion Criteria:

* Primary amyloidosis and secondary amyloidosis.
* History of liver transplant.
Genetic Analysis of Pediatric Psoriasis

This study will ascertain approximately 150 subjects, which will include pediatric psoriasis patients diagnosed before age 12, parents not affected by psoriasis, and if a family history is indicated, up to third-degree family members. Saliva (or buccal swabs in the case of infants) will be obtained for DNA isolation.


Eligibility Criteria:
Inclusion Criteria:

* Patients (of any age) who developed psoriasis before 12 years of age and who have no family history of psoriasis in either parent.
* Parents of patients who developed psoriasis before 12 years of age
* Up to third-degree family members (first cousin, grandparent, great-grandparent) with or without psoriasis, if family history is indicated.

Exclusion Criteria:

* Patients, parents, and other family member unable to give a saliva or buccal swab sample.
* Patients, parents, and other family member unable to give written informed consent.
Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing (RESCUE1)

An early feasibility study to investigate the safety and feasibility of the Lungpacer Diaphragm Pacing Therapy System (DPTS) as a therapy to recondition and strengthen the diaphragm of patients who have been intubated and invasively mechanically ventilated for \> or = 7 days, have failed two or more spontaneous breathing trials (SBT), and were not hypervolemic during the latest SBT.

Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventilator induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphragm begins to atrophy within as little as 18 hours. The DPTS is a temporary therapy that consists of the Lungpacer IntraVenous Electrode Catheter (LIVE Catheter) and the lungpacer Control Unit (LCU) system. The LIVE Catheter is a proprietary central venous catheter that incorporates pacing electrodes in strategic areas that align with the left and right phrenic nerves in order to stimulate the nerves to recruit the diaphragm. The LIVE Catheter can also be used for fluid delivery like any other central venous catheter. This early feasibility trial will investigate the safety and feasibility of the DPTS as a therapy to recondition and strengthen the diaphragm by stimulating the diaphragm through daily sessions so the patient may be more quickly liberated from MV. The patient population includes those who have been mechanically ventilated for \> or = to 7 days, have failed two or more SBTs, and were not hypervolemic during the latest SBT. Patients must have resolution of the initial indication for placement on MV before entering the trial.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* have been mechanically ventilated for \> or = 7 days and have not met criteria for successful weaning during this period; and
* have failed at least two SBTs, one of which is the study specific SBT. (Self-extubation with subsequent reintubation within 48 hours is considered a failed SBT).

Exclusion Criteria:

* currently on extracorporeal membrane oxygenation (ECMO);
* weaning failure due to hypervolemia;
* known anatomy that prevents insertion of the LIVE Catheter into the left subclavian vein;
* history of congenital heart disease;
* clinically overt congestive heart failure;
* pre-existing neuromuscular diseases that could affect the respiratory muscles;
* pleural effusions occupying greater than one third of the pleural space on either side;
* BMI \> or = 40;
* known or suspected phrenic nerve paralysis;
* any electrical device (implanted or external) that may be prone to interaction with or interference from the Lungpacer DPTS including neurological pacing/stimulator devices, cardiac pacemakers and defibrillators;
* bacteremia (blood cultures must be negative for 48 hours);
* current haemodynamic instability, shock or severe sepsis;
* terminally ill with 6 months or less life expectancy or not committed to full care;
* known or suspected to be pregnant or lactating; and
* actively participating in another clinical study
Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in cell samples from young patients with acute myeloid leukemia.

OBJECTIVES:

* To characterize Stat3 signaling pathway activity in primary tissue samples from pediatric patients with acute myeloid leukemia to determine the percentage of samples with increased activity and to better understand the mechanisms leading to increased activity.
* To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low and high doses of cytokines.
* To evaluate the expression levels of Stat3 protein as well as upstream and downstream regulators of Stat3 activation.
* To classify tissue samples according to a Stat3-activation pattern, and to correlate this result with event-free survival and overall survival in order to determine whether increased Stat3 phosphorylation at diagnosis predicts poor outcome.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including immunoblotting, fluorescence activated cell sorting (FACS), and protein analysis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Impact of Imipenem With Amikacin Pharmacokinetic and Pharmacodynamic

The study is a prospective open trial conducted in 4 centers, and designed to determine if pharmacokinetic (PK) and pharmacodynamic (PD) parameters of imipenem, associated with amikacin as empirical therapy, impact microbiological and clinical outcome of patients with Gram negative bacilli (GNB) ventilator-associated pneumonia (VAP).

Inappropriate initial antibiotherapy increases mortality of many serious infections. This is the case for ventilator-associated pneumonia, frequently occurring during intensive care unit (ICU) hospitalization, and whose 48 first hours of treatment are decisive.

It is well established that pharmacokinetic and pharmacodynamic parameters of antibiotics are correlated with their clinical and microbiological effectiveness. However in ICU patients, pharmacokinetic parameters of antibiotics suffer great variations, and bacteria responsible for these infections are usually less sensitive to antibiotics, especially Gram negative bacilli (GNB). An important pharmacodynamic variability may occur at the initial phase of the antibiotic treatment, decisive for the infection's outcome.

We propose to evaluate the correlation between pharmacokinetic and pharmacodynamic profile of the empirical antibiotic therapy and the microbiological and clinical outcome of VAP.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Mechanical ventilation for more than 48 hours
3. Clinical suspicion of VAP defined by a new persistent radiological infiltrate and one of the following signs: purulent tracheal aspirations, or temperature of 38°3 or higher, or leucocyte count \> 10000/ml
4. Risk of multi resistant bacteria defined as follows: at least 6 days of mechanical ventilation or antibiotic treatment in the 15 previous days
5. Distal pulmonary secretion sample obtained beforehand for microbiological diagnosis by bronchoalveolar lavage via bronchoscopy or blinded protected telescoping catheter via bronchoscopy or blindly
6. Presence of GNB on direct examination of the distal pulmonary secretion sample
7. Realization of a preliminary medical examination. 8- Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives

Exclusion Criteria:

1. Time between distal pulmonary secretion sample taking and the 1st administration of imipenem exceeding 24 hours
2. Pregnancy
3. Severely impaired renal function (creatinine clearance lower than 10 mL/mn or renal replacement therapy)
4. Allergy to imipenem or amikacin
5. Treatment in progress with imipenem or amikacin
6. Death expected within 48 hours following diagnosis of VAP
7. Myasthenia
8. Simultaneous administration of others aminoglycosides
9. Association with intravenous polymyxin or botulinum toxin
The Benefit of Hippotherapy in Stroke Patients

This study aims to explore the interest of hippotherapy in the management of patients with stroke in the sequelae phase by evaluating the psychological and physical well-being. It is a controlled and randomized prospective longitudinal study.

Hippotherapy is a rehabilitation method entrusted to a paramedical or medical profession that uses the horse in its treatment program in addition to conventional medical care.

Hippotherapy has benefits at the psychomotor and motor level. The method is based on the use of the horse's characteristic movements when walking to provide sensory information and to induce motor adjustment responses mainly at the level of the pelvis and the trunk of the rider in order to work on balance, postural control, muscle tone and joint mobility of the patient sitting on his back. In particular for people with paresis or plegia sequelae, it contributes to rehabilitation programs. In addition, by inducing a helical movement of the pelvis, the horse's walk reproduces in the the disabled rider a pattern of trunk reactions very similar to that of the normal human walking pattern. This pattern can be integrated as a normal sensorimotor reaction and help the patient to improve his sitting balance and his coordination.

Hippotherapy is also interesting because getting out of the traditional rehabilitation framework and being in contact with an imposing animal has positive repercussions on the psyche and therefore on functional recovery.

All patients will undergo an assessment that will focus on their physical and psychological well-being at the beginning and end of the study as well as during a follow-up at 2 weeks, one month and 3 months.

Patients assigned to the experimental group (EG) will receive, in addition to their physical therapy, a weekly hippotherapy session of 30 minutes. The follow-up will take place during 3 months for a total of 12 sessions. The EG will also be monitored in the short term (before and after each session) for well-being and fatigue.

Quality of life will be explored using the SF-36 questionnaire and the SS-QOL scale. Self-esteem will be measured using the Rosenberg scale. Patients' physical abilities will be assessed with functional tests, standing balance measurements on a strength platform and the ABC-S self-evaluation scale.


Eligibility Criteria:
Inclusion Criteria:

* patients who have suffered a stroke and who are in a sequelae phase (after hospitalization or discharge from the rehabilitation center)
* patients who have sufficient trunk balance to hold on to the horse
* patients who have the consent of their doctor
* patients who indicated their agreement to participate in the study by signing the consent form

Exclusion Criteria:

* pressure sore at the seat level
* other lesion or neurological history
* severe cognitive deficits affecting the understanding
* do not understand French language
* allergy to horses
* weigh more than 100 kg
* acute pain syndrome
* epilepsy
* patient has benefited from hippotherapy sessions during the last 6 months
Effects on Anxiety in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview

The aim of the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history.

Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.

Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Exclusion Criteria:

* Students who do not wish to participate in the study.
Study of Oral Oteseconazole (VT-1161) for Acute Yeast Infections in Patients With Recurrent Yeast Infections

Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute vulvovaginal candidiasis (VVC) in the past 12 months. Several properties of oteseconazole (VT-1161) suggest it might be a safer and more effective treatment of RVVC than other oral antifungal medications.

This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of acute VVC episodes in patients with RVVC and consists of 2 parts. The first part of the study is a 2-week induction phase for the treatment of the patient's current VVC episode when the patient will take either fluconazole or oteseconazole (VT-1161) according to a random assignment. The second part consists of an 11-week maintenance phase, when the patient will take either oteseconazole (VT-1161) or a placebo according to the random assignment from the first part of the study, and then a 37-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* 3 or more episodes of acute VVC in the past 12 months
* Positive KOH test
* Total vulvovaginal signs and symptoms score of ≥3 at screening visit
* Total vulvovaginal signs and symptoms score of \<3 at Day 14
* Must be able to swallow pills

Exclusion Criteria:

* Presence or a history of another vaginal or vulvar condition(s)
* Evidence of major organ system disease
* History of cervical cancer
* Poorly controlled diabetes mellitus
* Pregnant
* Recent use of topical or systemic antifungal or antibacterial drugs
* Recent use of immunosuppressive or systemic corticosteroid therapies
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.


Eligibility Criteria:
Inclusion Criteria:

* Male or female at least 18 years of age;
* If female of childbearing potential, negative pregnancy test result;
* Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets \< 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
* Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).

Exclusion Criteria:

* Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
* Pregnancy or lactating;
* Blood dyscrasia other than HIT;
* History of thrombocytopenia associated with fondaparinux;
* Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
* Active bleeding of GI tract, GU tract, CNS or respiratory tract;
* Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
* Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
* Hypersensitivity or contraindication to warfarin or fondaparinux.