cyrilzakka/clinical-trials huggingface dataset:
Effects of Sleep Deprivation on Blood Hormones and Inflammatory Status After Exercise Induced-muscle Damage

The aims of this study are examine the effects of sleep deprivation in muscle recovery after a maximum eccentric resistance exercise session performed on an isokinetic dynamometer (24 series of 10 repetitions). The sample will consist of 10 men, sedentary, clinically healthy, aged between 20 and 31 years old. Two experimental groups will be developed: EXE-SLEEP, in which subjects will perform the exercise protocol (\~18:00-19:00) and will be subject to normal period of sleep for 3 nights; EXE-TOTAL, in which subjects will perform the same exercise protocol and will be sleep deprived for 60 hours, followed by one night of sleep rebound.

The blood parameters analyzed will be:

* Creatine kinase and myoglobin: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol.
* Total and free testosterone, IGF-1, and cortisol: before, immediately after, 2, 4, 12, 24, 36, 48, and 60 hours after exercise protocol. Moreover, from 19:00 of the second day to 19:00 of the third day it will be collected blood samples every 2 hours.
* GH: during the second night, GH will be evaluated every 1 hour, from 23:00 to 07:00.
* TNF-alfa, IL-6, IL-1 beta, IL-10, and IL-1ra: before, immediately after, and 2 hour after exercise, as well every 4 hours from 19:00 of the second day to 19:00 of the third day.

It will be evaluated isometric strength every 12 hours, as well visual analog scale of pain.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects
* sedentary
* sleep duration between 6-8 hours peer night

Exclusion Criteria:

* smokers
* use vitamin supplements, like C and E
* drink two doses of alcohol/day or \> 4 doses in one occasion
* use of anti-inflammatory drugs
* antilipidemic drugs
* anemia
* muscle or joint diseases
* cardiovascular diseases
* diabetes
* renal diseases
* sleep disturbances
* breathing disorders
Place of General Medical During Oncology Care Management

The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service.

Before leaving hospital, the patient completes the survey, other data are taken in patient record


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing oncology treatment or ≤ 1 year of the latest oncology treatments
* Patient hospitalized in a medical service in an unscheduled way
* Age \> or = 18 years old
* Patient informed and not opposed to the study
* Patient able and agreeing to follow all study procédures
* Patient must be affiliated to a social security system

Exclusion Criteria:

* Patient hospitalized in surgery and continuing care services
* Patient deprived of liberty or under supervision
The Efficacy of Autogenous Dentin Graft in Mandibular Wisdom Tooth Extraction

The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Symmetry mandibular third molars
* Symmetry maxillary third molars with no caries or periodontal disease
* Mandibular second molars are available

Exclusion Criteria:

* Systematic health has contraindication for surgery
* Pregnant or breastfeeding women
* Allergy with Lidocaine
* Abnormal signs surrounding mandibular third molars
Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin

The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.


Eligibility Criteria:
Inclusion Criteria

* Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion criteria

* Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results.
* Presence or history of any disorder that may prevent the successful completion of the study.
The Role of Tumor-associated Macrophages in Colorectal Liver Metastases

Colorectal cancer is a major cause of mortality worldwide. Most patients develop colorectal liver metastases (CLM), and for such patients hepatectomy combined with chemotherapy may be curative. Nevertheless, in the era of precision medicine there is a critical need of prognostic markers to cope with the heterogeneity of CLM patients. Tumor-associated macrophages (TAMs) pave the way to tissue invasion and intravasation providing a nurturing microenvironment formetastases. The quantification of immune landscape of tumors has provided novel prognostic indicators of cancer progression, and the quantification of TAMs might explain the heterogeneity of CLM patients. Here, we will investigate the development of a new diagnostic tool based on TAMs with the aim to define the causative role of TAMs in CLM patients. This will open new clinical scenarios both for the diagnosis, therapy and prognosis, leading to the refinement of the therapeutic output in a personalized medicine perspective.

Some preliminary data produced by the research team from Humanitas Clinical and Research Center in Milan (ITALY) have shown that TAMs in CLM are heterogeneous and that their diversity can be distinguished based on their morphology and functionality. Therefore, TAMs may represent an additional tool in the definition of the biology and prognosis of CLM patients. This preliminary finding provides us with the rationale to undertake a prospective study on a large series of CLM patients surgically resected by our unit aimed at validating the promisingcorrelation between different TAMs phenotypes and patients prognosis. The characterization of the diversity of TAMs in CLM will be refined using state of the art technology, including multi-parametric flow cytometry, single cell RNA sequencing (scRNA-seq) transcriptional profiling, metabolomic, and proteomic analyses. The expected findings will allow us to develop a new diagnostic tool based on TAMs features, which will open the way to new criteria for patient stratification and for the design of new targeted therapies in a personalized medicine perspective.

Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal liver metastases undergoing hepatectomy
* Full clinical, surgical, pathological and follow-up data
* Availability of tissues for the analysis

Exclusion Criteria:

* Missing (any) data
* Combination of radiofrequency or microwave ablation plus surgery
The Effect of Review of a Decision Aid Prior to the Appointment on Decisional Conflict Compared to Usual Care in the Treatment of Trapeziometacarpal (TMC) Arthritis

The investigators plan a prospective randomized controlled study that compares whether the use of a decision aid results in different scores on variables reflective of the decision-making process, behavior, health outcomes, communication, and healthcare system.

Decision aids (shared decision making tools-websites, videos, or pamphlets) are interventions to prepare patients to make more informed decisions and satisfying decisions that match their preferences and values. With greater understanding of the risks and benefits of the treatment options patients may make a more informed choice.

Decision aids - delivered online, on paper, or on video - increase patient participation in the decision-making process,1 and can result in a decrease in discretionary surgery for knee osteoarthritis, herniated disk, and benign prostatic hypertrophy.2-4 They also reduce decisional conflict. Relatively few studies have investigated the influence of decision aids in orthopedic or hand surgery. Decision aids might affect decisional conflict, satisfaction, and outcomes in hand surgery where many treatments are discretionary and address quality of life.

Utilizing the Ottawa Decision Support Framework- an evidence-based, practical theory used to guide the development of decision aids - and the International Patient Decision Aid Standards criteria the investigators developed a decision aid for trapeziometacarpal arthritis.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* English-speaking
* Diagnosis of trapeziometacarpal (TMC) arthritis

Exclusion Criteria:

* Prior surgical intervention for trapeziometacarpal (TMC) arthritis
* Previously accessed or used the online TMC arthritis Decision Aid (DA)
Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol

This study will evaluate the effect of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX) fixed-dose combination (FDC) + voxilaprevir on the pharmacokinetics (PK) of a representative hormonal contraceptive medication, norgestimate/ethinyl estradiol (Ortho Tri-Cyclen® Lo (OC)) and will assess the effect of norgestimate/ethinyl estradiol on the PK of SOF/VEL/VOX+VOX.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal female
* Must have a calculated body mass index (BMI) ≥ 19.0 and ≤ 30.0 kg/m\^2 at screening
* Must have a negative serum pregnancy test at screening and urine pregnancy test at Day -1
* Be willing and able to comply with all study requirements.

Exclusion Criteria:

* Lactating female
* Have a history of any of the following:

  * Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
  * Known hypersensitivity to the study drugs, the metabolites or formulation excipients
* Believed, by the study investigator, to be inappropriate for study participation for any reason
Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥27 kg/m2
* At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes \[IFG, IGT\], hypertension, dyslipidemia)
* Age \> 18 and \< 70 years old

Exclusion Criteria:

* Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
* Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
* Insulin dependent or treated type 2 diabetes
* Current use of other injectable incretins
* History of diabetes ketoacidosis
* Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) \< 30 mL/min/1.73m2
* Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
* Clinical or laboratory evidences of chronic active liver diseases
* Acute or chronic infective diseases
* Known or suspected allergy to Liraglutide, excipients, or related products
* Pregnant, breast-feeding or the intention of becoming pregnant
* Females of childbearing potential who are not using adequate contraceptive methods
Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment

The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change

The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.

Eligibility Criteria:
Inclusion Criteria:

* Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment \[aMCI\] or light cognitive confusion of type amnestic)
* The patient must be affiliated to an insurance scheme disease to participate in this study

Exclusion Criteria:

* For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
* Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
* Appointment of a guardian
Optimisation of Falls Prevention After Low-energy Osteoporotic Fractures: Feasibility Study

Within the Groupe Hospitalier Paris Saint-Joseph (GHPSJ), a reinforced medical care of osteoporosis ('Fracture Liaison service') was organized for osteoporotic fractured patients. The evaluation of benefits of this program through a randomized study showed an improvement in diagnostic tests performed (bone densitometry) and antiosteoporotic treatment initiated (OPTIPOST study, being published in BMJ). However, of 323 patients included, 91 presented a new fracture within 12 months. Among them, 40/126 patients (31.7%) were in the reinforced medical care arm. This result clearly demonstrates the need for a specific medical care program for patients with osteoporotic fracture falling regularly.

Only few studies for secondary prevention of falls have been conducted in France yet. This can be partly explained by the complexity of reeducation programs to implement and by organization issues. Moreover, to our knowledge, no study has demonstrated the benefit of such programs on secondary prevention of osteoporotic fractures, even though falls prevention is needed. Our objective is to demonstrate with a pilot study the feasibility of a falls secondary prevention program, based on a rheumatology (GHPSJ) and reeducation wards (Hôpital Sainte-Marie Paris : HSMP) collaboration. Considering the innovative nature of both this program and this collaboration, a feasibility study is preferable before conducting a larger multicentric study, evaluating locomoter benefits of this program in comparison with usual primary care.

Eligibility Criteria:
Inclusion Criteria:

* Men and women (age ≥ 60 years)
* Francophone
* Hospitalized patient or who is consulted in rheumatology or indicated for bone densitometry in Groupe Hospitalier Paris Saint-Joseph, who are suffered a low-energy osteoporotic fracture in the last 12 months
* Patient with an acceptable handicap level definied by a Timed Up \& Go test (TUG) \<14 seconds
* Autonomous patient with instrumental activities of daily living score (4 items) = 0/4 and Activities of Daily Living score (6 items) ≥5.5/6
* Patient with medical insurance

Exclusion Criteria:

* History of locomor specialized care for the falls prevention
* Cognitive impairment/diagnosed dementia or chronic neurological disorder, which doesn't permit the undertanding or a follow-up to a rehabilitation program
* Fall due to a neurovascular disease or acute cardiovascular
* Significant comorbidities which don't permit a locomotor rehabilitation care
* Refusal to participate in the study
* Refusal to follow the entire rehabilitation program
* Geographic remoteness which doesn't permit the movement to the rehabilitation center
* Contreindicated balneotherapy: incontinence, skin disease or cardiovascular disease
* Patient under guardianship or curatorship
* Patient deprived of liberty
Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients

Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.

We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.

The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.

We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.

We will compare the clinical factors at each time.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* HbA1C \> 7.0%
* BMI 23 - 34 or BMI 21-22 with viceral obesity
* insulin use less than 10 years
* uncerstanding the risks, hypothesis, expecting effects

Exclusion Criteria:

* type 1 diabetes
* C-peptide \< 1.0ng/ml
* BMI \< 21
* severe cardiovascular diseases or their history
* malignancy or history
* alcoholics, pituitary failrue
* history of severe ketosis, diabetic coma or precoma
* abnormal liver enzyme, over 3 fold of normal level
* liver cirrhosis or hepatitis
* serum creatinine \> 2.0mg/dL
* glucocorticoids user
* diabetes due to other endocrine diseases
* pancreatic disease
* anti-GAD Ab (+)
* the incongruity for surgery
Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members

RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.

OBJECTIVES:

* Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland.
* Assess the feasibility of mutation detection using sequencing and HPLC.
* Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data.

OUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patients diagnosed with melanoma and selected family members are eligible to participate
* Must live in Iceland

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD

The purpose of this study is to determine the maximum tolerated dose (MTD) of Pregnyl® when given in combination with standard immunosuppressive therapy in pediatric and adult patients with high-risk (Arm 1) or refractory/dependent (Arm 2) aGVHD.


Eligibility Criteria:
Inclusion Criteria:

* Acute graft versus host disease (GVHD) fitting one of the following categories:

  * High-Risk aGVHD (ARM 1): Pediatric or adult (ages 12-76 years) HCT recipients with high-risk acute GVHD, as determined by the refined MN acute GVHD risk score: http://z.umn.edu/MNAcuteGVHDRiskScore OR high risk on the basis of blood biomarkers (Ann Arbor Score 3 or amphiregulin ≥ 33 pg/ml) or
  * Steroid-Refractory aGVHD (ARM 2): Pediatric or adult (ages 12-76 years) HCT recipient with grade II-IV steroid refractory or steroid-dependent acute GVHD, defined as any one of the following:

    * No response of acute GVHD after at least 4 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent
    * Progression of acute GVHD within 3 days of systemic corticosteroids of at least 2 mg/kg prednisone or equivalent
    * Failure to improve to at least grade II acute GVHD after 14 days of systemic corticosteroids, with initial doses of at least 2 mg/kg prednisone or equivalent
    * Flare of acute GVHD of at least grade II/IV severity despite tapering dose of steroids being \> 0.5 mg/kg/day.
* Adequate organ function at study enrollment defined as:

  * Renal: 1.73m2Serum creatinine ≤2.5x upper limit of normal (ULN)
  * Cardiac: Left ventricular ejection fraction (LVEF) ≥ 35%
* Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)

Exclusion Criteria:

* Progressive malignancy
* Diagnosis of a hormone responsive malignancy
* Uncontrolled infection at initiation of protocol treatment
* Current thromboembolic disease requiring full-dose anticoagulation - patients receiving pharmacologic prophylaxis for thromboembolic disease will be eligible
* Active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
* Pregnancy as assessed on baseline blood hCG level
* Unwilling or unable to stop supplemental sex hormone therapy (estrogen, progesterone, and/or testosterone preparations)
* Women or men of childbearing potential unwilling to take adequate precautions to avoid pregnancy from the start of protocol treatment through 28 days after the last treatment

Screening Inclusion Criteria:

* Pediatric or adult (ages 0-76 years) HCT recipients
* Suspected high risk GVHD
* Voluntary written consent (adult or parent/guardian with minor assent for 12 through 17 year olds)
Evaluation of Arch Dimensions of Children With Surgically Repaired Unilateral Cleft Lip and Palate

The aim of the study is to assess arch dimensions among children with surgically repaired unilateral cleft lip and palate.

Measurements of arch widths will be performed in the maxillary and mandibular arches after performing a study cast. Alginate impression of the upper and lower arch of all participating children will be performed and poured immediately to prevent dimensional changes.

The inter-deciduous canine, inter-permanent molar, and the distances between the first and second deciduous molars will be measured using a digital caliper directly on dental casts by a single examiner.

Distance measurements will be obtained between cusp tips of canines, cusp tips of first deciduous molars, mesiobuccal cusp tips of second deciduous molars, and mesiobuccal cusp tips of first permanent molars. Estimated cusp tips will be used in cases of wear facets.

Rationale:

Children with cleft lip and/or palate suffer from problems in growth of the jaws, particularly the maxilla (upper jaw), as a result of surgical repairs of the cleft lip and palate. It is important to know the arch dimensions of them to enable the identification of specific surgical alterations related to maxillofacial growth concerning the common treatment protocol for patients with cleft lip and palate.

Benefits to the practitioner:

-Increase the awareness of pediatric dentists about changes of arch dimensions of surgically repaired cleft lip and palate patients in Egypt.

Benefits to the patient:

* Inform parents about any disturbances that might be associated with Cleft lip and Palate.
* Guide them to the orthodontic care if needed.

Benefits to the community:

* Provide the Egyptian community with data concerning patients with cleft lip and palate.
* Increase awareness of problems related to Cleft Lip and Palate.

Eligibility Criteria:
Inclusion Criteria:

* Children with cleft lip and palate from the age group: 8-10 years.
* Unilateral Cleft lip and palate children.
* Children who had been operated with lip and palate closure

Exclusion Criteria:

* Cleft lip and palate patients with systemic diseases, autoimmune conditions, syndromes.
* Children with any arch expansion or orthodontic procedure or previous history of orthodontic treatment.
* The presence of early loss of deciduous molars.
* Parents refusing participation in the study