cyrilzakka/clinical-trials huggingface dataset:
Sleep Apnoea Syndrome and Hepatocellular Carcinoma

Obstructive sleep apnea (OSA), one of the most frequent respiratory diseases, could represent a major worsening factor in a non alcoholic steatohepatitis and neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC related to NASH. This national, multicenter study aims to compare the prevalence of OSA in a group of patient curatively resected for NASH-related HCC with a group of HCV-related HCC.

Obstructive Sleep Apnea (OSA) is a common respiratory disease characterized by the occurrence of recurrent episodes of partial or total obstruction of the upper airway called hypopneas and apneas respectively. These episodes are associated with the repetitive occurrence of the desaturation-reoxygenation sequences, the so-called chronic intermittent hypoxia (IH) which is the major stimulus underlying main cardiovascular, metabolic consequences and pro-inflammatory state found in patients with OSA. Recent data from cohort studies have established that OSA is an even greater risk factor for cancer-related mortality. Hepatocellular carcinoma (HCC) is the second cancer related death worldwide and has an increasing impact in developed countries. The epidemic of metabolic syndrome (MS) plays a growing role in the occurrence of metabolic steatohepatitis (NASH) related HCC. Concerning transition from NASH to NASH-related HCC, neither the frequency nor the underlying mechanism are known. Very recently, a link between OSA (IH) and NASH has been highlighted. OSA and intermittent hypoxia should be a major worsening factor in a neoplastic context. Our hypothesis is that OSA promotes the prevalence of HCC in a context of NASH.

The objective is to compare the prevalence of OSA between patients with NASH-related and hepatitis C virus (HCV)-related HCC. In this type 3, cross-sectional, multicenter, national, non-randomized study patients suffering from a NASH-related or HCV-related hepatocellular carcinoma will be recruited. Investigators expect to show a higher prevalence of OSA in patients with HCC NASH-related but also a shorter overall survival. Complementary ex vivo studies on tumor samples will be conducted in order to explore the mechanisms by which OSA and IH would promote carcinogenesis

Eligibility Criteria:
Inclusion Criteria:

* Man and woman
* \>18 years
* Diagnosis of NASH-induced HCC or HCV-induced HCC
* Patients treated by surgical excision
* Patients not opposed to the study

Exclusion Criteria:

* Patient refusal
* Alcohol consumption\> 20g / day for women and\> 30g / day for men
* Patient with HCV genotype 3
* Tumor vascular invasion identified preoperatively
* Other etiologies of hepatopathies (alcoholic, viral B, autoimmune, hemochromatosis)
* Other chronic respiratory diseases: chronic obstructive pulmonary disease, respiratory insufficiency
* Patient weight variation \>5% since surgical treatment of his HCC
* Subject deprived of liberty or under guardianship
Use of Jet-injection in Photodynamic Therapy for Basal Cell Carcinoma

The purpose of this study is to find out whether injecting ALA into the skin with a jet-injection device and activating the drug with light is a safe treatment that causes few or mild side effects in people with basal cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria are eligible to participate in this study

* Histologically-verified, previously untreated low-risk mixed superficial and nodular BCC(s) or nodular BCC(s) \< 1 cm in diameter on scalp, extremities, or trunk.
* ≥ 18 years of age
* Owner of a smartphone (Android or iPhone). Patients without a working smartphone will not be considered eligible for this study.
* Being able to download application on their phone
* Being able to take pictures of their treated BCC(s) (with or without assistance)
* Female subjects of childbearing potential must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment. (Female subjects are considered of childbearing potential unless they have been hysterectomized or have undergone tubal ligation or have been post-menopausal for at least one year prior to the first visit)
* Legally competent, able to give verbal and written informed consent
* Subject in good general health and willing to participate comply with protocol requirements.
* Superficial and nodular BCC(s)

Exclusion Criteria:

Subjects meeting any one of the following criteria are not eligible to participate in this study

* High-risk BCC(s) (H area, \>1 cm in M area, or \>2 cm in L area)
* BCC(s) subtype morpheaform
* Diagnosed with gorlin syndrome
* Receiving immunosuppressive medication
* Subjects with a known allergy to ALA
* Individuals with other interfering skin diseases in the area of treatment
* Subjects with a tattoo in the treatment area which may interfere with or confound the evaluation of the study
* Subjects with a history of keloids which is deemed clinically relevant in the opinion of the investigator
* Lactating or pregnant women
* Patient who are taking prescription pain medications or can not stop OTC pain medications.
Can Modified Coronally Advanced Tunnel be an Alternative in Gingival Phenotype Modification?

In the randomized comparative controlled trial, 50 patients with insufficient keratinized tissue at the anterior mandible were treated with either Modified coronally advanced tunnel or epithelialized free gingival graft. At baseline, 6th week, 6th month, 12th-month visits; keratinized tissue height, gingival thickness, recession depth, recession width, probing depth, and clinical attachment level, were evaluated. Keratinized tissue change, Gingival thickness change, root coverage, clinical attachment gain, and complete root coverage were calculated. Wound healing index, tissue appearance, patient expectations, aesthetics, and dentine hypersensitivity were assessed at baseline and 6th week.


Eligibility Criteria:
Inclusion Criteria:

* presence of at least two anterior mandibular teeth with keratinized tissue height≤1 mm with gingival thickness ≤1mm
* presence of at least two recession type-1 recessions at mandibular anterior teeth and at least one recession with recession depth ≥2 mm,
* aged between 18-60.

Exclusion Criteria:

* unstable endodontic conditions or presence of any restoration/abrasion,
* tooth mobility, any surgical history or gingival enlargement in the area,
* smoking or alcohol use,
* uncontrolled systemic disease, pregnancy or use of drugs known to affect gingival conditions
Interchromosomal Insertion Carriers PGT-SR

Interchromosomal insertions (IT) are rare and complex structural rearrangements. Theoretically, the risk to have a child to term with a malformation or mental retardation can reach 50% related to the proportion of unbalanced gametes produced from behavior of chromosomes during meiosis. However, the meiotic segregation of IT has rarely been studied. This study provide an accurate reproductive risk of IT carriers resulting from a combined analysis of Sperm-FISH and preimplantation genetic testing for structural rearrangement (PGT-SR) management of IT carriers.


Eligibility Criteria:
Inclusion criteria:

- Adult patient whom carrying Insertional translocation in the context of PGT-SR management

Exclusion Criteria:

- Patient who reject the study protocol
Minipuberty in Infants Born With Potential Hypogonadism Hypogonadotrope

Disorders of sex development (DSD) occur in 1/3000 births and are defined by variation in aspect of external genital organs, e.g. cryptorchidism, hypospadias and micropenis in male infants and clitoral hypertrophy in female infants. Genetic, hormonal and environmental factors are implicated in DSD. Infants with congenital hypogonadism hypogonadotrope (CHH) can present with DSD. Evaluation of hormonal profile during minipuberty could be of great help to better characterize the etiology of DSD and CHH in particular. Our main objective is to study hormonal profile during the minipuberty of infants born with DSD or born from parents with CHH compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* infants born with symptoms of DSD
* infants born from parents with CHH

Exclusion Criteria:

* premature \< 35 weeks of gestation
* male infants with high scrotal cryptorchidism
Patient Behavior in Region H: How Does Illness Affect How You Act and Master Your Life?

This study investigates how the behavior within different patient groups are affected differently by illness and disease. The investigators ask how participants experience and approach their own health in order to gain insight on the implications of illness and disease on the individual's everyday life and how participants act and think regarding their own health and wellbeing across different patient groups. The investigators' hypothesis is that illness and disease is experienced as a great disturbance and an actor of change in a person's everyday life. Each person has their own individual experience and reaction to this disturbance. Still, there is less evidence for how disparate resources and socioeconomic statuses shape how patients react to this great change in their lives. Here the investigators expect to find demographic patterns across patient groups. The study carries a quantitative and qualitative approach with a broad target population which includes both patients with acute or chronic, serious, or less serious, somatic as well as psychiatric illnesses. The study is placed within the academic traditions of sociological health and disease mapping.


Eligibility Criteria:
Inclusion Criteria:

* The patient is assigned to Region H
* The patient is over the age of 18
* The patient is able to answer the questions

Exclusion Criteria:

* - The patient refuses to give informed consent
* The patient doesn't speak danish
Pivotal Study in Nosocomial Pneumonia Suspected or Confirmed to be Due to Pseudomonas

This is a phase 3, multicenter, open-label, sponsor blinded, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous murepavadin given with ertapenem versus an anti-pseudomonal β-lactam based antibiotic in the treatment of nosocomial pneumonia in adult subjects


Eligibility Criteria:
Key Inclusion Criteria:

* Subject has received mechanical ventilation for at least 48h at the time of the randomisation OR at least 2 of the following signs or symptoms presenting within 24 hours prior to randomization: New onset of cough or worsening of baseline cough and/or dyspnea, tachypnea and/or hypoxemia and/or new onset of sputum or suctioned respiratory secretion characterized by purulent appearance indicative of bacterial infection or a worsening in character of purulent appearance
* Acute Physiology and Chronic Health Evaluation (APACHE) of 8 to 25, inclusive, within 24h prior to randomization
* Presence of new or progressive infiltrate on chest X-ray
* Presence of clinical criteria consistent with Pneumonia
* Strong clinical suspicion of pneumonia due to P. aeruginosa

Key Exclusion Criteria:

* Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia
* known hypersensitivity to any component of ertapenem, meropenem or to other drugs in the same class or demonstrated anaphylactic reactions to beta-lactams or a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors
* Severe liver or renal impairment
* Expected survival \< 72 hours
* Evidence from an available surveillance culture of co infection with ertapenem , meropenem or piperacillin tazobactam resistant Gram negative pathogen(s)
* Women who are pregnant or nursing
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors

The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.

Eligibility Criteria:
Inclusion Criteria:

* women with histologically confirmed stage 0, I, II, or III breast cancer
* who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
* are currently receiving adjuvant endocrine therapy
* are able to read and speak English
* with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms

Exclusion Criteria:

* have self-reported hospitalization for psychiatric illness within the past 2 years
* have a bleeding disorder
* physically or cognitively unable to complete the study procedures
* pregnant women
Physical Therapy in Lipedema Surgery

The goal of this observational study or clinical trial is to know evaluate the effects of a modified Complete Decongestive Therapy protocol using the Godoy Method in the postoperative period following lipedema surgery.

The main question it aims to answer are:

* if the treatment is effective on pain reduction, edema resorption, mobility improvement in short term and follow-up at 90 days
* if the treatment is effective on preventing complications of these participants after surgery

Participants have been treated in the lasts years and authors recover information of the effects of the treatment.

Researchers will compare sub-groups of participants depending on the number of physical therapy sessions received

Background: Lipedema is an adipose tissue disorder in women, with an abnormal fat deposition in lower limbs and occasionally upper limbs. The patients present pain, bruising, heaviness, and mobility impairment. It affects them physically and psychologically. Purpose: This study aims to evaluate the effects of a modified CDT protocol using the Godoy Method in the postoperative period following lipedema surgery.

Outcomes: pain (VAS), edema resorption, complications, mobility and patient satisfaction.

A descriptive statistical analysis will be performed using means and standard deviation (quantitative outcomes) and percentages (dichotomous and categorical outcomes). An inferential analysis will be carried out using paired and unpaired T-tests as One-way and repeated measures ANOVA to search for differences between quantitative outcomes. Pearson chi-square will also be used to relate dichotomous and categorical variables in a transversal analysis. All missing values will be excluded from the analysis. In all cases, a P\<0.05 value and a 95% confidence interval will be determined forstatistical significance. All statistical analysis will be performed using the Stata® version 14.2 package for MS Windows® version 10.

Eligibility Criteria:
Inclusion Criteria:

* female subject who underwent a lipedema surgery
* recommendation of the surgeon to receive physical therapy

Exclusion Criteria:

* unilateral surgery
* lack of data in the clinical history
* only 1-2 physical therapy sessions
Randomized Study of Pregabalin for Pain Reduction in Patients With Rest Pain and Lower Limb Ischemia

The hypothesis behind the trial is the concept that Pregabalin is effective in reducing pain at rest in lower limb ischemia, and the study evaluates active treatment or placebo added to the regular pain regimens for these patients.

Critical limb ischemia (CLI) is the end stage of peripheral arterial disease in the legs and is a consequence of deteriorating blood flow supply to the lower limbs. The clinical definition of CLI includes peripheral arterial disease and recurrent rest pain for at least two weeks with or without ulcers or gangrene.

In patients not amenable to revascularization - around 35% - amputation or palliative conservative care remains the options. Pain control is a vital part of any treatment of these patients. Besides being the principal conservative treatment, also patients undergoing revascularization experience severe pain both during work up and after surgery.

Experimental data indicate that pain in CLI is multimodal and to a large extent neuropathic. Still, current therapy is mostly based on opioid treatment, which clinically often affects pain moderately. The doses required to influence pain are also associated to severe side effects. Accordingly, there is a great need to improve pain control in the rather common disease CLI.

comparisons: pregabalin up to 600mg daily in addition to regular pain regimens compared to placebo and regular pain regimens.

Eligibility Criteria:
Inclusion Criteria:

* Rest pain, gangrene or ulcers located below the patella for a duration of at least two weeks (either one of these criteria are sufficient).
* One measurement of: Ankle blood pressure(ABP) \<70 mm Hg, an toe blood pressure(TBP) \<50, or a TcPO2\<45 mm Hg, or an ankle/brachial pressure index \<0.7 (either one of these criteria are sufficient).
* Informed consent obtained

Exclusion Criteria:

* Age \< 55 years
* Women of childbearing potential
* Patients already medicating with Pregabalin or Gabapentin
* Creatinine clearance \<30ml/min
* Amputation necessary within two weeks
* Revascularization necessary within two weeks (open vascular surgery or endovascular)
* A medical history of clear dizziness
* NYHA class IV heart failure
* Known hypotension, or having a systolic arm blood pressure \<120 mm Hg (two consecutive measurements with the patient lying supine)
* Simultaneous or previous (within 30 days prior to study entry participation in a clinical study using experimental drugs or devices
* Mental condition making the subject unable to understand the concepts and risk of the study
* Known allergies against pregabalin
Beneficial Effect of Salicylates: Insulin Action, Secretion or Clearance?

The possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2DM) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. Several studies, performed in patients with 2DM, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved.

In this research proposal we will use specific methods to quantify insulin mediated glucose uptake (IMGU), glucose-stimulated insulin secretion rate (GS-ISR), and insulin clearance (I-Cl) in overweight/obese, nondiabetic, insulin resistant individuals. We will use the insulin suppression test (IST) to quantify IMGU in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. We will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both GS-IS and I-Cl. Following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the IST and the graded glucose infusion will be repeated to quantify and compare the changes in IMGU, GS-ISR, and I-Cl that have resulted from salsalate versus placebo. These results will provide for the first time quantitative data of the effect of salicylates on IMGU, GS-ISR, and I-Cl in overweight/obese, insulin resistant, nondiabetic individuals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers,
* BMI 25-35kg/m2,
* Without severe anemia, kidney, liver disease or any current GI ulcers or bleeding
* Or on any medication contraindicated with salsalate

Exclusion Criteria:

* Recent history of GI bleed or ulcers,
* CVD or on anticoagulants
* Severe kidney or liver disease
* Allergies to aspirin
* Taking aspirin or anti inflammatory medication on a regular basis and cannot be taken off for the duration of the study
A Study of Mitoguazone Dihydrochloride in Patients With AIDS-Related Non-Hodgkin's Lymphoma

To estimate the response rate, response duration, clinical benefit, and toxicity of mitoguazone dihydrochloride (MGBG) in patients with AIDS-related refractory or relapsing non-Hodgkin's lymphoma (NHL).

Patients receive infusions of MGBG on days 1 and 8 and every 2 weeks thereafter. It is suggested that a lumbar puncture be performed to evaluate for leptomeningeal disease.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity by ELISA confirmed by Western blot.
* AIDS-related NHL that is refractory or relapsed.
* Life expectancy of at least 12 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* Concomitant malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.
* Active uncontrolled bacterial infection, viral infection (other than herpes simplex), or fungal infection (other than oropharyngeal candidiasis) that requires treatment within 2 weeks of study entry.
* Significant cardiovascular disease.

Concurrent Medication:

Excluded:

* Hormonal therapy (except medications given for muscle wasting, such as testosterone or Megace).
* Other chemotherapy.
* Investigational anti-cancer drugs.

Concurrent Treatment:

Excluded:

* Concomitant radiation to sites other than CNS.

Patients with the following prior conditions are excluded:

Prior malignancy OTHER THAN curatively treated carcinoma in situ of the cervix; basal or squamous cell carcinoma of the skin; or non-active, non-visceral Kaposi's sarcoma not requiring active chemotherapy.

Recommended:

* Prophylaxis for PCP and oral candidiasis.

Required in patients with leptomeningeal disease:

* Intrathecal methotrexate or cytarabine (Ara-C).
* Leucovorin.

Required in patients with leptomeningeal disease:

Cranial radiation to a helmet field.
Alcoholism and Schizophrenia: Effects of Clozapine

The purpose of this study is to examine the short - term effects of clozapine on alcohol use in persons with schizophrenia and an alcohol use disorder. The hypothesis is that clozapine will have greater efficacy in reducing alcohol use than other antipsychotic medications.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Current diagnosis of an alcohol use disorder with active use in the last 30 days.
* The participant (or the participant's authorized legal representative) understands the nature of the study and has he/she signed an informed consent.
* Ages 19-65.
* Taking olanzapine, risperidone, quetiapine or a typical antipsychotic agent for at least 8 weeks prior to study randomization
* If taking depot medication, at least 3 injection cycles since the last injection prior to study randomization.

Exclusion Criteria:

* Contraindication to clozapine
* Women who are currently pregnant or who desire to become pregnant during the course of the study.
* Current and past treatment with clozapine
* Current treatment with agents proposed to curtail substance use (e.g., disulfiram, naltrexone, acamprosate, buspirone) and agents contraindicated for use with clozapine (e.g., inderal, tegretol, lithium).
* Meets DSM-IV criteria for current dependence of substances other than alcohol.