cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects

This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
3. Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
4. Women participants must have documented proof that they are not of childbearing potential.
5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.

Exclusion Criteria:

1. Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
2. History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
3. Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds
A Multicenter Study to Evaluate the Effects of a 91-day Oral Contraceptive on Bone Mineral Density in Adolescent Females

This study is being conducted to compare the effects of a 91-day oral contraceptive (OC) to a 28-day OC regimen on bone mineral density (BMD) in adolescent females.

Participants will be randomized to either a 91-day OC or a 28-day OC. Participants not seeking hormonal contraception who meet eligibility criteria will serve as a control group. Duration of the study for each study participant will be approximately 13 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenarchal adolescent female 12-18 years old, non-pregnant, nonlactating
* Regular spontaneous menstrual cycles
* Body mass index (BMI): 18 kg/m² to \<30 kg/m², weight \< 200 lbs
* Others as dictated by the Food and Drug Administration (FDA)-approved protocol

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* History of previous clinically significant adverse event while taking hormonal contraceptives
* Use of any medication which could significantly interfere with study assessments
* Others as dictated by FDA-approved protocol
Strengthening of the First Dorsal Interosseous for Thumb Carpometacarpal Osteoarthritis

To determine the effect of first dorsal interosseus (FDI) strengthening in patients with thumb carpometacarpal (CMC) osteoarthritis.

Thumb CMC osteoarthritis is a normal part of aging. Most patients are able to adapt to symptoms of pain and disability, other patients might benefit from non-operative interventions; e.g. splinting, corticosteroid injections, pain medication, and multiple hand exercises.

The dorsal ligament complex is one of the components for stability of the thumb CMC joint. These ligaments specifically create stability for pinch and grip during the final phase of opposition. Both, the opponens pollicis (OP) and the first dorsal interosseous (FDI) play a key role in centralizing the metacarpal on the trapezium. A retrospective study showed that a dynamic stability modeled approach, including targeting the FDI, reduced pain and improved function in patients with thumb CMC osteoarthritis. Recently, another study demonstrated that reduction of radial subluxation - the thumb metacarpal versus the trapezium CMC joint - was achieved by contraction of the dynamic stabilizers of the healthy hand, specifically with the focus on the FDI.

More clinical research is needed to determine if there are efficacious (effective and low-cost) evidence-based exercise programs for pain reduction and functional improvement in patients with thumb CMC osteoarthritis. The investigators are interested in the effect of FDI strengthening in patients with thumb CMC osteoarthritis. Therefore, the investigators hypothesized that there is no difference in the change of lateral pinch strength at 12 weeks between patients treated with a splint versus patients treated with a splint and FDI strengthening for thumb CMC osteoarthritis. We also tested the same hypothesis for 3-point chuck strength, VAS for pain, and PROMIS Upper Extremity CAT.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* English-speaking
* Splint treatment for thumb carpometacarpal (CMC) osteoarthritis

Exclusion Criteria:

* Less than 18 years old
* Rheumatoid Arthritis or post-traumatic carpometacarpal (CMC) osteoarthritis
* Patients that received a corticosteroid injection during the appointment for treatment of thumb carpometacarpal (CMC) osteoarthritis
Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession

The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.


Eligibility Criteria:
Inclusion Criteria:

* Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket)
* Patients with good oral hygiene
* Medically free patients
* No signs of active periodontal disease (with no site showing probing depth \> 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth).
* Palate with sufficient thickness to accommodate soft tissue defect.

Exclusion Criteria:

* Smokers
* Pregnancy
* Severe gag reflex
* Non-carious cervical lesion
* History of mucogingival or periodontal surgery at the experimental site
* History of medication that can affect periodontal healing
Stroke and Assessment of Muscle Tone

Spasticity is defined as a state of increased muscle tone, which evokes an increased resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity depends, among other things, on the stretching velocity performed to the muscle. However, most of the tools used in the clinical setting to assess spasticity do not take into account the relationship between increased muscle tone and speed of stretching. Instead of that, muscle tone is usually assessed in a relaxed position of the muscle.

Likewise, to date, despite the functional disabilities related to the presence of chronic pain after a stroke, no previous study has correlated muscle tone and pressure pain sensitivity within this population


Eligibility Criteria:
Inclusion Criteria:

* Be older than 18 years
* Clinical diagnosis of stroke, confirmed using a MRI.
* No previous history of other strokes.
* Increases muscle tone in upper and lower extremities (punctuation equal to or superior to 1 in the Tardieu Scale, Ashworth Scale)
* Ability to understand the study goals, follow simple instructions and provide informed consent.
* Score equal to or superior to 24 in the Minimental State Examination.

Exclusion Criteria:

* Any other confirmed neurological disorder that may influence muscle tone (multiple sclerosis, Parkinson, muscle dystrophies...)
* A chronic musculoskeletal disorder in the upper or lower limb.
* Previous history of surgery in the upper or lower extremities.
* Changes in the medication intake that may affect muscle tone assessments in the 48 hours before data collection.
* Having received botulin toxin in gastrocnemius or biceps brachii muscles in the 30 days before data collection.
* A concomitant acute infection during data collection.
* A previous epileptic crisis in the week before the study or during the study.
Safety and Immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP Vaccines in Malaria Endemic Areas

The purpose of this trial is to assess the safety and immunogenicity of AdCh63 ME-TRAP and MVA ME-TRAP candidate vaccines in healthy adult volunteers in a malaria endemic region. The regime proposed in this trial has protected non-immune volunteers against sporozoite challenge in clinical trials performed by Oxford, and so may be protective against naturally acquired infection in Kenya.The study population will comprise 30 healthy adult males aged 18-50.

The investigators do not propose to include a placebo group. At this stage the investigators objective is to describe the safety profile in a small number of individuals, and the confidence intervals for the proportion of individuals with a particular event would be too wide for meaningful comparison with a placebo group. Immunogenicity will be judged by comparison with baseline.


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult males aged 18-50 years in good health.
* Will remain resident in the study area for the study duration

Exclusion Criteria:

* Clinically significant history of the following conditions; skin disorder (eczema, etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness.
* History of splenectomy
* Haemoglobin less than 9.0 g/dl
* Clinically significant abnormalities of laboratory screening tests (full blood count, ALT, creatinine levels, urine dipstick examination for blood and protein).
* Blood transfusion within one month of the beginning of the study
* History of vaccination with previous experimental malaria vaccines
* Administration of any other vaccine or immunoglobulin within two weeks before vaccination.
* Current participation in another clinical trial, or within 12 weeks of this study
* Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
* Likelihood of travel away from the study area
* HIV positive.
* History of contact dermatitis (due to the use of a potentially irritant disinfectant that may be present in trace amounts in the AdCh63 ME-TRAP vaccine, see the investigators brochure for details, attached)
Prospective Randomized Trial Comparing Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Surgisis

To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using the Surgisis ES soft tissue graft, as a mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.

Inclusion and Exclusion Criteria

Inclusion criteria:

* Male, adult patients
* ASA I-III patients
* Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
* Informed consent

Exclusion criteria

* Recurrent hernias
* Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
* Hypersensitivity to any drug in study
* Patients with an intra-operative findings of different pathology will be excluded from the study

Outcomes:

General objectives of the study will be:

1. to determine the safety of the Lichtenstein's hernioplasty with Surgisis ES by noting any complications observed intraoperatively and postoperatively
2. to determine the efficacy of the Lichtenstein's hernioplasty with Surgisis ES in comparison with the traditional method with polypropylene mesh by noting the grade of postoperative pain, discomfort, quality of life, the rate of wound infection and other complications, and the recurrence rate.

The specific objectives of the study will be:

1. to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), simple verbal scale (SVS) and parenteral/oral analgesic consumption in the two groups.
2. to measure the degree of postoperative acute and chronic discomfort with visual analogue scale (VAS) and simple verbal scale (SVS).
3. to measure the postoperative health general status and quality of life with the Short Form 36 (SF-36) questionnaire.
4. to rate the wound infection risk.
5. to monitor any other postoperative complication observed in the immediate, mid-term and long-term postoperative period.
6. to measure the recurrence rate.

Eligibility Criteria:
Inclusion Criteria:

* Male, adult patients
* ASA I-III patients
* Non-complicated primary inguinal hernia (classification according to Gilbert I-II-III-IV-V-VI, modified. according to Rutkow and Robbins) performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty using polypropylene or Surgisis mesh
* Informed consent

Exclusion Criteria:

* Recurrent hernias
* Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
* Hypersensitivity to any drug in study
* Patients with an intra-operative findings of different pathology will be excluded from the study
Influence of Patient Position on Attenuation Artifacts Observed in D-SPECT Camera Myocardial Tomoscintigraphy

The purpose is to compare percentages of myocardial segments showing attenuation in patients in forward tilted position (biker position) or 2 conventional positions (dorsal decubitus or semi sitting) at acquisition with D-SPECT camera in myocardial tomoscintigraphy.

The hypothesis is that the percentage of myocardial segments with attenuation is significantly lower when acquisitions are made in forward tilted position (biker position).

The secondary purpose is to restrict this analysis to 3 cardiac regions most subject to attenuation artifacts (anterior, apical and inferobasal regions).

Myocardial perfusion tomoscintigraphy is a very used technique for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion (ischemia, infarction).

A common problem is attenuation artifacts that are due to tissue interposition attenuating radiation from some cardiac regions. These artifacts originate activity decreasing and thus perfusion abnormalities potentially in all walls of left ventricle, especially the inferior wall in men (attenuation by sub-diaphragmatic organs) and the anterior wall in women (attenuation by mammary glands). These artifacts are observed in rest and stress acquisitions and can lead to a wrong diagnosis of infarction.

Attenuation artifacts can be identified with analysis of contraction kinetics with "gated-SPECT" (normal kinetics and thus discordant with aspect of infarction). With D-SPECT camera some artifacts can be prevented with a 30-35° forward tilted position of acquisition. This position, also called biker position, can take cardiac area away from sub-diaphragmatic structures. It can also reduce the distance between heart and detection surface of camera and limit respiratory movements of thoracic wall.

In this study, patients with abnormal results at stress myocardial perfusion tomoscintigraphy will undergo a rest tomoscintigraphy. Acquisition will be done in forward tilted position and in one of 2 other positions: dorsal decubitus or semi sitting.

Eligibility Criteria:
Inclusion Criteria:

* Affiliation to social security
* Signed informed consent
* Previous clinical examination authorizing patient to undergo tomoscintigraphy
* Patient with abnormal results of stress tomoscintigraphy and needing a rest tomoscintigraphy
* Patient with sinus and regular cardiac rhythm
* Patient with stable clinical status (without signs of unstable cardiac or coronary failure, without uncontrolled hypertension under treatment)

Exclusion Criteria:

* Women of childbearing potential without effective contraception
* Evolutive pregnancy
* Breastfeeding patient
* Contraindication to tomoscintigraphy
* Patient with history of hypersensibility to tomography radiotracer STAMICIS® or one of components
* Patient in life-and-death emergency
* Patient with history of disorders possibly interfering with contractility
* Patient with normal results of stress tomoscintigraphy
* Person under legal protection or incapable to consent
* Person deprived of liberty by judicial or administrative decision
Polymorphism of ApoE in Alzheimer's Disease: Genetic Study in Castile and Leon (Spain)

The general objective of this randomized and longitudinal clinical study was to estimate the frequencies of ApoE variants both in the user population of the "Messengers of Peace" Residences and the "Associations of Relatives of Alzheimer's Patients" in Castile y Leon, since, due to its geographical location at the crossroads, it has received multiple genetic contributions from both northern Europe, the Mediterranean area and northern Africa.

The main questions it aims to answer are:

* What are the allelic frequencies of ApoE variants in the population of individuals with Alzheimer's disease in Castile and Leon?
* Is there a correlation between the ApoE4 variant and the lipid profile in the blood of individuals with Alzheimer's disease in this region?

In the context of Alzheimer disease research, it is widely recognized that the ApoE gene plays a fundamental role in the genetic predisposition of this disease. With three major alleles: ApoE2, ApoE3, and ApoE4, genetic variability in the ApoE gene has been the subject of extensive attention in previous research and its association with increased risk of Alzheimer's disease has remained consistent. Within this framework, three hypotheses are proposed focused on understanding the specific influence of ApoE on Alzheimer's disease and exploring the possible underlying mechanisms.

Within this framework, three hypotheses are proposed focused on understanding the specific influence of ApoE on Alzheimer disease and exploring the possible underlying mechanisms:

1. - Research hypotheses: The genetic variant ApoE4/4 is significantly related to a higher risk of developing Alzheimer's disease compared to individuals who do not carry this genotype.
2. - Research hypotheses: The ApoE2/2 genetic variant is associated with a lower risk of developing Alzheimer's disease compared to other genotypes.
3. - Research hypotheses: People who carry the ApoE4 isoform have elevated levels of total cholesterol and LDL-cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Be between 60 and 90 years old.
* Subjects with a diagnosis of AD in the case group.
* Subjects free of AD diagnosis in the control group.
* Subjects who voluntarily and consented to participate free of charge.
* Have completed the written consent

Exclusion Criteria:

* Subjects who, at the time of sample collection, had behavioral or other alterations that made the sample collection procedure impossible.
* Subjects who, at the time of sample collection, presented oral alterations incompatible with the technique.
HDtDCS in Logopenic Variant PPA: Effects on Language and Neural Mechanisms

This study aims to evaluate the effectiveness of a therapy called High-Definition Transcranial Direct Current Stimulation (HD-tDCS) for the treatment of the language deficits experienced by people with a type of Primary Progressive Aphasia. This study uses a combination of brain imaging, language assessment, language training sessions, and HD-tDCS therapy as well as placebo therapy sessions.

The logopenic variant of Primary Progressive Aphasia (lvPPA) is an untreatable neurodegenerative disorder that is often referred to as the 'language form' of Alzheimer's Disease (AD). Transcranial Direct Current Stimulation (tDCS) has emerged as a safe and potentially effective tool that appears to enhance language production when delivered during language training. This technology provides a critical opportunity to conduct disease intervention.

In this study, the investigators will test the hypothesis that High-Definition tDCS (HD-tDCS) will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. The rationale for this project is that a determination of the therapeutic efficacy and the associated neural mechanisms of HD-tDCS in lvPPA is likely to offer a scientific framework whereby new stimulation parameters, conditions, and target sites can be deciphered.

This study will test the hypothesis that HD-tDCS will improve performance on language tasks by increasing functional connectivity and by regulating abnormal neuronal oscillatory patterns. The language performance and functional connectivity changes will be determined in a randomized, double-blind, sham-controlled crossover manner, in which a stimulation of up to 2mA in the targeted cortical tissue or sham is administered to 20 lvPPA subjects age 45 years and older. The order of treatments is counterbalanced in a within-subject crossover design. In brief, study participants will receive sham during one treatment period and stimulation during the other treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with language variant Primary Progressive Aphasia (lvPPA) subtype, defined as either clinical lvPPA or imaging-supported lvPPA in accordance with the most recent diagnostic criteria (Mesulam., 2001; Gorno-Tempini et al., 2011).
* Fluent in English.
* 45 years of age or older.
* Structural brain MRI performed within 3 years prior to enrollment.

Exclusion Criteria:

* Severe cognitive, auditory or visual impairments that would preclude cognitive testing.
* Presence of major untreated or unstable psychiatric disease.
* A chronic medical condition that is not treated or is unstable.
* The presence of cardiac stimulators or pacemakers.
* Any metal implants in the skull
* Contraindications to MRI
* History of seizures
* History of dyslexia or other developmental learning disabilities.
Hydrodissection of the Hepatoduodenal Ligament

Percutaneous treatment of liver lesions adjacent to the duodenum exposes the duodenum to the risk of thermal injury, limiting removal and oncologic outcome. In this study the investigators investigate the feasibility of hepato duodenal ligament dissection in the percutaneous treatment of liver lesions adjacent to the duodenum.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years of age)
* Subject who underwent percutaneous ablation of primary or secondary liver lesions at HUS that required per-procedure hepatoduodenal ligament hydrodissection in the interventional imaging department of the New Civil Hospital from January 2019 to July 2022.
* Subject who has not expressed opposition to the reuse of their data for the purpose of this research.

Exclusion Criteria:

- Opposition to the reuse of his/her data for the purpose of scientific research.