cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Low-molecular Weight Heparin for Thromboprophylaxis in Acutely Ill Medical Patients

Acutely ill immobilized patients are at a high risk for thromboembolic events including deep venous thrombosis or pulmonary embolism. Unfractionated heparin (UFH) and low molecular weight heparins (LMWH) are thought to be effective in preventing thromboembolic events. This study is designed to provide efficacy and safety data for thromboprophylaxis with the LMWH certoparin in comparison to thromboprophylaxis with UFH in acutely ill non-surgical patients.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalization due to an acute non-surgical disease
* Significant decrease in mobility

Exclusion Criteria:

* Indication for anticoagulant or thrombolytic therapy
* Major surgical or invasive procedure within the 4 weeks that precede randomization
* Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization
* Immobilization due to cast or fracture of lower extremity
* Immobilization lasting longer than 3 days in the period prior to randomization
* Heparin administration longer than 36 hours in the period prior to randomization
* Acute ischemic stroke

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy

The objective of this study is to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil on cataplexy in patients with narcolepsy

BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.

The objective of this POC study are firstly to evaluate and compare the efficacy and safety of escalating doses of BF2.649 and BF2.649 add on Modafinil (200 mg/day) on cataplexy attacks, and secondly to evaluate the additive/synergistic effect and safety of the combination of BF2.649 and Modafinil on EDS as assessed by both of objective and subjective measures including ESS, MWT, patients sleep diary.

Eligibility Criteria:
Inclusion Criteria:

* "De novo" patients with newly diagnosed narcolespy and cataplexy , and not taking any treatment for Excessive Daytime Sleepiness(EDS) and cataplexy
* patients with previously diagnosed narcolepsy and cataplexy and not taking any treatment for EDS and cataplexy for more than 3 months
* partial or total cataplexy attacks with a frequency of at least 5 per week during a 14 day baseline period and ESS \>or= 14 at the end of the baseline period

Exclusion Criteria:

* Patients who are unable or unwilling to temporarily discontinue any no-authorized drugs or substances
* Current or recent history of a substance abuse or dependence disorder including alcohol abuse
* Psychiatric and neurological disorders such as psychosis or dementia, bipolar illness, severe anxiety, clinical depression, history of seizure disorder or other problem that in the investigator's opinion would preclude the patient's participation
Melatonin's Effects on Treatment Of Diabetes Mellitus

The aim of this study is to assess the efficacy and safety of melatonin in control of blood sugar in patients with type 2 diabetes mellitus (DM).

Diabetes mellitus (DM) is a major public health problem with increasing worldwide incidence. The main causes for increase in incidence of DM are inactivity, obesity and changes of dietary habits. Investigators think that the changes in the awake-sleep cycle may also contribute to higher incidence of DM in recent years. Melatonin is an important component of the circadian system. Numerous experimental studies have demonstrated that melatonin has many beneficial actions.Melatonin is a potent antioxidant, reduces inflammatory process, lowers blood pressure, improve lipid profiles. Collectively, these data suggest that melatonin may be useful in control of blood sugar in patients with DM.

The aim of this study is to assess the efficacy of melatonin in control of blood sugar in patients with type 2 DM.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus diagnosed by an endocrinologist for more than six months
* FBS=120-160mg/dl
* HbA1C\<8%

Exclusion Criteria:

* Melatonin sensitivity
* Impaired fasting glucose (IFG)
* Impaired glucose tolerance (IGT)
* Under Insulin therapy
* Pregnancy
* Lactation
* Diabetic autonomic neuropathy and orthostatic hypotension
* Renal failure (Creatinin\>1.5mg/dl)
* Diabetic retinopathy
* Diabetic nephropathy
* Malignancy
* Alcohol use
* Liver disease
The Risk Assessment Scale for Peripherally Inserted Central Venous Catheter (PICC) Related Thrombosis in Cancer Patients

The aim of this study is to compare the accuracy and clinical predictive value of the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale （Chinese version）in predicting PICC-related thrombosis.

The aim of this study is to compare the accuracy and clinical predictive value of the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale（Chinese version） in predicting PICC-related thrombosis.

Patients who will receive PICC placement will be evaluated by using the Michigan Risk Score, Caprini Risk Assessment Model , and Maneval Scale the day during PICC placement, 24-48h after PICC placement and every time patients receive PICC maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients
* Older than 18 years
* Being able to complete the questionnaire independently
* Patients who need PICC for treatment
* Being able to perform catheter maintenance in the hospital of admission until catheter removal
* Patients who agree to participate and sign the consent form

Exclusion Criteria:

* Patients who were or suspected to be allergic to the ingredients contained in PICC
* PICC placed in the lower extremity
The Effectiveness of Tailored Messages on the Usage of Emollient in Patients With Atopic Dermatitis

Atopic dermatitis is the most common chronic inflammatory skin disease in children and severely affects quality of life (QoL) of patients and their parents. The application of topical medications and emollient is the mainstay of the treatment, but complexity of the treatment and lack of self-care knowledge cause poor adherence, leading to therapeutic failure. Adequate education about the chronic disease and its treatment was known to improve the treatment adherence. There are a variety forms like generalized information leaflets and video clips for imparting information to patients and individualized tailoring education was considered more effective way to improve patients' adherence. The aim of this study is to determine the efficacy of tailored education in dermatology area, especially the emollient usage in patients with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* A parent of 0-5 year old children with mild to moderate atopic dermatitis
* 20 years of age or older
* Apply emollient for themselves to their children with atopic dermatitis

Exclusion Criteria:

* Parents of children with severe atopic dermatitis or showing signs of acute infection (Oozing, vesicles, edema, redness or pain)
Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19.

CALAVI US will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with Best Supportive Care in the treatment of COVID-19.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
2. Men and women ≥18 years of age at the time of signing the informed consent form
3. Confirmed infection with SARS-CoV-2 confirmed per World Health Organization criteria (including positive RT-PCR nucleic acid test)
4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation \<94% on room air or requires supplemental oxygen
5. Able to swallow pills
6. Willing to follow contraception guidelines

Exclusion Criteria:

1. Respiratory failure at the time of screening due to COVID-19 pneumonia that impedes the ability to swallow pills, or in the opinion of the treating physician, the subject is likely to require mechanical ventilation within the immediate 24 hours and therefore unable to swallow pills.
2. Known medical resuscitation within 14 days of randomization
3. Pregnant or breast feeding
4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARS-CoV-2)
5. Alanine aminotransferase (ALT), and/or aspartate aminotransferase (AST) and/or bilirubin ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment detected during the screening period (per local lab) Exception: AST and/or ALT ≤5 × ULN if considered due to underlying COVID-19 disease, but cannot be associated with concurrent elevated bilirubin (≤2 × ULN).
6. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll
7. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug).
Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.

The objective of our observational prospective study will be to compare, for women treated for infertility and included in a ICSI program, the implantation rate and delivery rate obtained after the transfer of a single blastocyst , chosen in a group of patients on the basis of the embryo morphology and in the other group on the basis of both embryo morphology and follicular fluid cytokines content.

100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort \< 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.

Patients will be part of one of the following groups:

Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.


Eligibility Criteria:
Inclusion Criteria:

* women age from \< 38 years
* normal body mass index (BMI ) from 18 to 26
* parameters for ovarian reserve in the normal range (day 3 FSH levels \< 10 mUI/ml ; day 3 E2 levels \< 80 pg/ml; anti-mullerian hormone (AMH) levels \> 1.5 ng/ml ; AFC (antral follicular count) \> 6 )

Exclusion Criteria:

* polycystic ovary syndrome (PCOS)
* ovarian surgery
* pelvic endometriosis
* POR according to ESHRE criteria
The Use of Candy and Honey in Decreasing Salivary Gland Damage Following Radioiodine Therapy for Thyroid Cancer

The purpose of this study is to determine whether the use of honey mouthwashes in the prevention of salivary side effects of 131I (radioiodine) therapy.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* They had a histological diagnosis of papillary, follicular, medullary or anaplastic thyroid cancer
* They had undergone total thyroidectomy
* They were able to provide consent

Exclusion Criteria:

* patients who had distant metastases,
* a history of salivary-gland disorders,
* collagen tissue disease
* diabetes mellitus,
* previous radioiodine therapy or external radiation to the head or neck
* allergy to the honey
The Therapeutic Effects of Topiramate and Metformin on Second Generation Antipsychotics-induced Obesity

The primary aim of the study is to investigate the efficacy of metformin and topiramate on second-generation antipsychotic-induced obesity. The secondary domain we look at is the adverse effects of both drugs. The investigators hypothesize that metformin and topiramate are effective in treating obesity induced by second-generation antipsychotics.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis: schizophrenia or schizoaffective disorder
2. Age: 20 to 65
3. BMI\>27
4. Receiving second-generation antipsychotics(Olanzapine, Clozapine, Quetiapine, Risperidone, Amisulpride, Zotepine)

Exclusion Criteria:

1. Allergy to metformin or topiramate
2. Currently taking metformin or topiramate
3. Currently taking drugs that may interact with topiramate, including carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, amitriptyline, lithium, metformin, propranolol, and sumatriptan.
4. Being pregnant or planning to become pregnant during the study period,
5. History of hypertension, DM, liver or renal function impairment, cardiovascular disease, CVA, or neurological disorders
6. History of hypoglycemia
7. History of suicidal attempt
8. Current scale of Hamilton Depression Rating Scale\>8
A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma

Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic melanoma
* Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed
* Normal organ and marrow function
* Willing to submit to blood sampling for planned PK/PD analyses
* Ability of understand and willingness to sign a written informed consent

Exclusion Criteria:

* No other investigational or commercial agents or therapies
* Prior exposure to GMX1777, GMX1778 or CHS828
* Patients with uncontrolled, intercurrent illness
* Pregnant or breastfeeding women
A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea

The purpose of this study is to compare the efficacy of two Metronidazole Gels 1%, in the treatment of Rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female subjects with at least 18 years of age;
* Read and signed ICF;
* Clinical Diagnosis of Rosacea;

Exclusion Criteria:

* Females who are pregnant, lactating or of childbearing potential who are not using or do not agree to use an acceptable form of contraception;
* Any skin condition that would interfere with treatment of rosacea
* Use of prohibited medications
Cognitive-Behavioral Therapy for Adults With ADHD: A Qualitative Study

This is a qualitative study of participants who have taken part in a randomized controlled trial (RCT) of a new treatment protocol based on cognitive-behavioral therapy for adults with attention deficit/hyperactivity disorder predominantly inattentive presentation. The purpose of the qualitative study is to explore participant perceptions of taking part in the RCT to further develop and improve the new treatment protocol.


Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of ADHD inattentive presentation
* 18 years of age or older
* If on medication, it needs to be well-established since three months, and
* Prior psycho-educational intervention

Exclusion Criteria:

* Intellectual impairment
* Substance use disorder
* Difficulties in adherence to medical or other treatment
* Social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or
* Simultaneous psychological treatment
Assessment of the Tolerability of Dry Airflow in the Nasal Cavity During Sleep

Preliminary data show that high flow nasal air has been shown to reduce promote heat exchange due to evaporation of nasal mucus by the air flow resulting in heat loss. It is unclear whether unidirectional nasal airflow is well tolerated in healthy individuals. The central hypothesis of this proposal is that dry high flow nasal air will be sufficiently tolerated in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Able to consent
* Age ≥ 18
* BMI\<30kg/m2

Exclusion Criteria:

* Previous diagnosis of obstructive sleep apnea or sleep disorder
* History of Constant Positive Airway Pressure treatment for Obstructive Sleep Apnea
* History of recurrent epistasis
* Pregnancy (self-report)
* Deviated nasal septum
* Unstable cardiovascular disease (decompensated Congestive Heart Failure, myocardial infarction or revascularization procedures, unstable arrhythmias)
* Uncontrolled hypertension with BP \> 190/110
* Daytime hypoxemia with oxygen saturation\<90% (measured at history and physical examination)
* Supplemental oxygen use
* Work in transportation industry as a driver or pilot.
The Effects of Vibration on Hypoxia

The purpose of this study is:

1. To study the effect of whole-body vibration on partial pressure of oxygen in arterial blood (PaO2), under hypobaric hypoxic conditions.
2. To study the effects of whole-body vibration and hypobaric hypoxia on visual contrast sensitivity.
3. To se if there is an increase in cytokines and other biomarkers under different hypobaric hypoxic conditions Our main hypothesis is that whole-body vibration may cause PaO2 to drop to a lower level, at a given altitude; than would be the case if there were no vibration present.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* Stay at altitude over 2000 m last two weeks prior to study-start.
* Severe head injury
* Cardiovascular disease
* lung disease
* Decompression sickness
In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers

The purpose of this study is to investigate the accuracy of a Smart Foot Mat for signals associated with diabetic foot ulcers in high-risk patients.


Eligibility Criteria:
Inclusion Criteria:

* Male/Female, 18 years or older
* Diagnosis of type 1 or type 2 Diabetes Mellitus, controlled or uncontrolled
* Ankle Brachial Index (ABI) \>0.5
* Patient with history of previous foot ulcer.

Exclusion Criteria:

* Active Charcot foot disease
* One or more plantar foot ulcers (UT Grade 1A-C, 2A-C \& 3A-C)
* Active Infection/Gangrene
* Active malignancy
* Immunosuppressive disease
* History of alcohol or drug abuse
* Pregnant women (verbal confirmation or confirmation obtained within current medical records)
* Cognitive deficit
* 2+ or great lower extremity edema
* End stage renal disease
* History of major lower extremity amputation (below knee or above knee amputation)
* Other issue that, at the discretion of the investigator, renders the subject ineligible for participation.
Associated Balance of Risk Score - Comprehensive Complication Index for the Prediction of Post-transplant Survival

In recent years, several scoring systems have been developed aimed at predicting early post-LT graft function. However, many of them showed poor efficacy when long-term survivals were tested. Moreover, the necessity to find an easy-to-use score represents another obstacle, with several scores composed by numerous, difficult to find, variables. Recently, the pre-LT Balance of Risk (BAR) and the post-LT Comprehensive Complication Index (CCI) have been created, but their external validation and integration in this setting is lacking.

This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-liver transplant (LT) independent variables, in order to accurately predict long-term graft survival after LT.

In the last years, several scoring systems have been developed with the intent to predict waiting-list mortality or early allograft dysfunction (EAD) after liver transplantation (LT). The Model for End-stage Liver Disease (MELD) is recognised as the most accurate liver allograft allocation model by prioritising patients according to the severity of their disease. However, several studies showed that MELD alone failed to predict early and late post-transplant clinical course. Consequently, other scoring systems based on pre-LT or post-LT variables have been developed, with the intent to identify high-risk cases for death, graft loss or re-transplantation (re-LT). Among them, two pre-LT scores, namely the D-MELD and Balance of Risk (BAR), showed to well predict early post-LT survival. Similarly, some post-LT scores were able to estimate EAD, and, thereby, to predict the probabilities of early re-LT and patient death. Interestingly, all of these scores, especially those based on pre-LT variables, resulted in a scarce prediction of long-term (five-year) survivals.

Recently, the Comprehensive Complication Index (CCI) has been developed in order to better capture complication rates after surgery. Some reports reported its excellent prognostic ability in different fields. However, up to now, no studies investigated the role of CCI concerning long-term prognostication of graft loss in LT.

This study aims at constructing an easy-to-use score system based on the combination of a small number of pre- and immediately post-LT independent variables, in order to accurately predict five-year post-LT graft survival. Both external and internal validations of the score were performed.

Eligibility Criteria:
Inclusion Criteria:

* First transplant
* adult (\>18 years)

Exclusion Criteria:

* living donation
* re-transplant
* combined transplant
* domino transplant
* paediatric transplant
Efficacy Study of VA106483 in Males With Nocturia.

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males.

The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged ≥18 years (no upper limit) with nocturia
* Generally well (concomitant illness/conditions well controlled)
* Serum sodium within the normal limits
* Normal or not clinically significant prostate specific antigen levels
* Able to comply with the requirements of the study
* Provide written informed consent

Exclusion Criteria:

* Prostatic cancer
* Signs or symptoms of heart failure
* Peripheral pitting oedema extending ≥10 cm above the ankle
* Palpable bladder or pelvic mass on abdominal examination
* Enuresis or night-time incontinence
* Excessive nocturnal void frequency
* Sleep disorders
* Diabetes insipidus or uncontrolled diabetes mellitus
* Presence of blood or glucose in the urine on urinalysis that is clinically significant
* Urinary tract infection
* Polydipsia
* Syndrome of inappropriate antidiuretic hormone secretion
* Body mass index ≥35
* High calcium levels or low potassium levels
* Other protocol defined eligibility criteria may apply