cyrilzakka/clinical-trials huggingface dataset:
Telecoached Exercise Intervention for Connectivity Enhancement in Small Vessel Disease (TELECONNECT-SVD)

The TELECONNECT-SVD study is a prospective, randomized, multicenter trial aimed at testing the efficacy of a remotely delivered exercise protocol on brain functional connectivity in patients with small vessel disease (SVD)-related ischemic stroke. The study will recruit patients aged ≥60 with a history of lacunar stroke, minimal disability (modified Rankin Scale score 0-1), and low physical activity levels.

The trial will include 60 participants randomized 1:1 to either a 24-week telecoached exercise intervention or usual care. The exercise program consists of multicomponent physical exercises delivered remotely twice a week. Assessments will be conducted at baseline, 12 weeks, 24 weeks, and 48 weeks.

Primary outcomes include changes in brain functional connectivity assessed by high-density EEG and improvements in physical fitness measured by the Senior Fitness Test. Secondary outcomes encompass changes in physical activity levels, anthropometric measurements, and vital signs.

The study employs a "wait list" design, where the control group receives the intervention after the initial 24-week period. This approach allows for assessment of the intervention's immediate effects and the retention of benefits after cessation.

Key features of the protocol include:

* Use of telecoaching to enhance adherence to the exercise program
* Comprehensive assessment of brain connectivity using advanced EEG analysis techniques
* Focus on patients with SVD, who may benefit significantly from exercise interventions
* Evaluation of both neurophysiological and clinical outcomes

The study aims to provide evidence for the potential benefits of exercise in enhancing brain connectivity and physical fitness in SVD patients, potentially informing future treatment guidelines and preventive strategies for this population.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥60 years;
* History of lacunar stroke occurred between 3 months and 10 years from screening and confirmed by neuroimaging or clinical data by an expert stroke physician;
* Modified Rankin Scale (mRS) score of 0-1, indicating no symptoms or no significant disability;
* A level of physical activity below recommended targets, i.e. \<150 minutes per week of moderate-to-vigorous exercise (24);
* Ability to sign informed consent.

Exclusion Criteria:

* Uncontrolled hypertension;
* Heart disease impairing the possibility of safely following an exercise protocol at the discretion of the treating physician;
* Primary or secondary epilepsy;
* Prostheses, implants, and any device that might impair the performance of either high-density electroencephalogram or the exercise intervention;
* Cognitive impairment (Mini Mental State Examination score ≤26 at follow-up);
* Lack of access to Internet-based facilities or poor technological alphabetization impairing the adherence to the trial protocol;
* Any major physical or psychiatric comorbidity that in the judgement of the treating physician might compromise the ability to undergo an exercise intervention.
POlycythemia, Proteins and ErYthropoiesis

Erythropoiesis encompasses all the stages and mechanisms involved in the production of red blood cells, or erythrocytes, under the control of a large number of regulatory agents, most often proteins. Among these proteins, erythropoietin and interleukin-3 play a major role. Similarly, proteins involved in iron metabolism (erythroferrone, hepcidin, ferroportin, transferrin, ferritin) influence erythrocyte production more or less directly. The regulation of erythropoiesis is a fine, complex mechanism involving a large number of players, not only through the stimulation of hypoxia pathways to control erythropoietin synthesis, but also through the availability of iron, an essential element for erythropoiesis. Excessive erythrocyte production can lead to polycythemia, the causes of which are varied, primary or secondary, acquired or constitutional. The aim of this work is the descriptive study (quantitative and/or qualitative) of the various proteins involved in the regulation of erythropoiesis in patients with polycythemia. These proteins will be measured in the plasma of patients obtained after blood sampling or bloodletting (bloodletting being the most common treatment for polyglobulic patients) and will be compared with the proteins of patients without polycythemia.


Eligibility Criteria:
Inclusion Criteria:

- Persons who have given their non-opposition

Patients with polycythemia:

* haemoglobin value \> 16 g/dl female or \> 16.5 g/dl male
* with a well-identified cause: either primary (polycythemia Vaquez, erythropoietin receptor or LNK/SH2B3 mutation...) or secondary \[cardio-respiratory pathologies, renal pathologies (post-transplant, polycystic kidney disease), metabolic pathologies, tumour (leiomyoma, pheochromocytoma...), constitutional mutations (hyperaffine haemoglobins, HIF2/EPAS1, PHD/EGLN1, VHL, ...)

Patients control:

- persons with a similar pathology to that of polycythemia patients, essentialy secondary, but without polycythemia, i.e. with a haemoglobin value of \< 16 g/DL for women and \< 16.5 g/DL for men

Exclusion Criteria:

* Person subject to a measure of legal protection (guardianship, tutorship)
* Person subject to a court order
* Pregnant, parturient or nursing woman
* Incapable of expressing consent
* Minor
The Study of Efficacy and Safety of a 60-day Use of the Magnox Comfort Compared to the Placebo in Subjects With NLC

A randomized, multicenter, prospective, double-blind, placebo-controlled, clinical trial in the parallel groups to determine the efficacy and safety of a 60-day use of the dietary supplement Magnox Comfort compared to the placebo in subjects with nocturnal legs cramps

At the beginning of the study, study subjects undergo a 14-day screening period during which the number of episodes of NLC is recorded. For further participation in the study, they must have at least 4 NLC episodes. Thereafter, an examination of compliance with the study requirements is performed and study subjects are randomized to one of the two groups: for a 60-day of IP use (1 capsule of Magnox Comfort daily) or to the control group (1 capsule of placebo daily).

Eligibility Criteria:
Inclusion Criteria:

1. The study subject is informed and he/she was given enough time to think on his participation in the study and signed the informed consent form before the beginning of any procedures;
2. A study subject is a man or a woman over the age of 45 years;
3. The study subject has an established diagnosis of the nocturnal legs cramps;
4. The study subject understands the Ukrainian language;
5. The study subject has satisfactory results of the neurological examination of both lower extremities;
6. The study subject has a telephone and can use it permanently;

Exclusion Criteria:

1. The onset of one of the non-inclusion criteria;
2. The study subject has less than 4 episodes of NLC during the 14-day screening period;
3. There is necessity for significant change in the treatment tactics.
Thalidomide Therapy for VEOIBD

This is a single center, observational study to investigate the clinical outcomes of thalidomide treatment for very early onset inflammatory bowel disease

Very early onset inflammatory bowel disease (VEOIBD) refers to IBD diagnosed before 6 years of age. VEOIBD comprises a distinct subset of pediatric IBD characterized by stronger genetic predisposition, predominant colonic involvement, more extensive inflammation, more severe course, and peculiar response to treatments. Previous studies have been demonstrated that thalidomide, an oral molecule with immunomodulatory, antiangiogenic, and TNF-suppressing properties, is an effective and safe treatment for adults and children with IBD refractory to conventional therapies. This study is aimed to evaluate the efficacy and tolerance of thalidomide in VEOIBD.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with inflammatory bowel disease
* disease onset less than 6 years old
* Pediatric Crohn's disease Activity Index (PCDAI)\>30 or Pediatric Ulcerative Colitis Activity Index (PUCAI)\>35
* patients and their legal guardians were willing to receive thalidomide treatment and participate in this study.

Exclusion Criteria:

* liver dysfunction
* allergy to thalidomide
* with Neuropathy
* with thrombosis
* thalidomide treatment in the previous 30 days
* biologics treatment in the previous 8 weeks
* not suitable participated in this study
Laparoscopy in Complicated Groin Hernia

This study assessed the outcomes of laparoscopic repair in complicated groin hernia. Laparoscopic approach in cases of complicated groin hernia can achieve desirable patient outcomes without major complications, provided good patient selection and expertise. This study provides an insight to the outcomes from the procedure in low resource setting of Nepal.


Eligibility Criteria:
Inclusion Criteria:

* Patients with age greater than 18 years with diagnosis of complicated groin hernia

Exclusion Criteria:

* Patients with features of peritonitis, history of previous abdominal surgery and those unfit for general anesthesia
Hydrochlorothiazide (+) Losartan Potassium vs. Amlodipine Comparative Study (0954A-314)

An efficacy and safety study of hydrochlorothiazide (+) losartan potassium compared to amlodipine at week 12 in Korean patients with essential hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients of age 20 70 75 with essential hypertension
* SiDBP 90 \~ 114mmHg at V1 \& V2

Exclusion Criteria:

* Patient has known or suspected secondary hypertension
* Patient has a history of malignant hypertension (SiSBP \> 210mmHg)
* Individuals has a known sensitivity or intolerance to HCTZ or any AIIAs, or any sulfonamide-derived drugs.
* Patient has shown significant abnormal laboratory evaluations
A Trial to Reduce Hepatitis C Among Injection Drug Users - 1

The purpose of this study is to examine the efficacy of a brief motivational intervention on the cumulative incidence of Hepatitis C.

Injection drug users are at high risk for blood-borne viral infections during their first years of injecting when they are least likely to seek formal substance abuse treatment, and are likely to be practicing risky drug-use behaviors. Research has demonstrated that a brief motivational intervention that includes booster sessions and addresses drug and sex risks is effective in reducing HIV risk behaviors among injection drug users.

Because Hepatitis C Virus is a bloodborne pathogen like HIV, and transmission occurs via similar behaviors, successful HIV prevention strategies should be robust in preventing HCV but need to be tested. Motivational interventions, which aim to elicit a goal and plan from the patient to reduce injection and sexual risk taking, are particularly suited to address behaviorally-based changes. Motivational interventions are individualized and tailored to the risks and concerns of the participant, but can be standardized and evaluated to make this technique applicable in a variety of settings. The occurrence of injection drug use in a population with traditionally poor linkage to primary care, an enormous burden of illness, and high HCV and other blood-borne pathogen transmission risk, supports the use of motivational interventions in this group.

Comparison(s): Participants are assigned, in this 24 month longitudinal study, to an assessment-only condition or an assessment plus motivational intervention condition. Participants in the intervention condition receive up to 4 sessions of motivational interviewing during the first 6 months of the study.

Eligibility Criteria:
Inclusion Criteria:

* current opiate or cocaine use
* HCV seronegative
* able to complete the study procedures in English

Exclusion Criteria:

* current enrollment in a formal substance abuse treatment program
A Single-center, Prospective, Clinical Study of VersaWrap Utilization in the Hand

The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the hand/fingers, including tendon repair, fracture repair, or tenolysis of the hand/fingers. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively

This is a prospective, post-market, observational, single center study evaluating the use of VersaWrap. Patients identified by the Investigator in his practice as needing surgery of the hand/fingers and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18-70 at the time of surgery
2. Patients undergoing hand/finger surgery, including tendon repair, fracture repair or tenolysis
3. Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule, study requirements with a signed informed consent with a study collaborator present at the time of signing to ensure compliance.

Exclusion Criteria:

1. Non-English speaking
2. Known allergy or sensitivity to citrate, alginate or hyaluronate
3. Pregnant or breastfeeding
4. Currently a prisoner
5. Patient has any condition, that in the opinion of the Investigator, would prohibit the patient from complying with the protocol
Fatty Acid Oxidation Defects and Insulin Sensitivity

The purpose of this study is to learn more about what causes insulin resistance. It has been suggested that proper breakdown of fat into energy (oxidation) in the body is important to allow insulin to keep blood sugar in the normal range. The investigators want to know if having one of the fatty acid oxidation disorders could have an influence on insulin action. Fatty acid oxidation disorders are genetic disorders that inhibit one of the enzymes that converts fat into energy. The investigators will study both normal healthy people and people with a long-chain fatty acid oxidation disorder.

The overall goal of this proposal is to investigate the effects of disordered mitochondrial fatty acid oxidation on insulin resistance in humans. Mitochondrial dysfunction has been implicated in the development of insulin resistance and type 2 diabetes during excess dietary fat intake and from increased release of endogenous free fatty acids , such as occurs in obesity. Controversy exists, however, as to whether this insulin resistance results from intrinsic defects in mitochondrial energy utilization or from abnormalities resulting from excess free fatty acid flux, as well as the role that subsequent accumulation of cellular metabolic intermediates play in impaired insulin signaling.

To address these controversies, the investigators will study a unique population of patients with inherited defects in each of the three mitochondrial enzymes in the fatty acid oxidation pathway: 1) very long-chain acyl-CoA dehydrogenase (VLCAD); 2) trifunctional protein (TFP, which includes long-chain 3-hydroxyacyl-CoA dehydrogenase (LCHAD)); and 3) medium-chain acyl-CoA dehydrogenase (MCAD). These proteins are required for the oxidation of sequentially shorter fatty acids . The investigators will test the hypothesis that intrinsic defects in mitochondrial function involving oxidation of long-chain, but not medium-chain, fatty acids are sufficient to prevent intralipid-induced insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of VLCAD, LCHAD, TFP or MCAD deficiency or same gender, age and BMI as a subject with a fatty acid oxidation disorder
* ability to travel to Oregon Health \& Science University, Portland, Oregon
* ability and willingness to complete the protocol

Exclusion Criteria:

* hemoglobin \<10g/dl, international normalized ratio (INR) \>1.2 Prothrombin time (PTT) \>36 sec, Platelets \<150K/mm3
* pregnant or lactating females
* endocrine disorder such as diabetes or untreated thyroid disease
* cardiovascular disease or elevated plasma lipids
* regularly taking meds that strongly affect bleeding, bruising or platelets
Clinical Trial Evaluating the Safety and Efficacy of Moxidectin 2 Mg Ivermectin-controlled in Loa Loa Microfilaremic Patients

This study aims at evaluating the safety and efficacy of Moxidectin 2 mg in patients with low intensities of microfilariae of Loa loa.

This clinical trial will be randomized, double blind, and will compare Moxidectin to ivermectin. This study will be conducted in Cameroon.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent written, signed (or with a cross) and dated
* Men aged 18 to 65 included (women not included in the study)
* Microfilarial density between 1 and 1,000 mf/mL
* body weight ≥ 45 kg and less than 85 kg
* Good general condition, as determined by the medical questionnaire and clinical examination
* Hematological parameters and adequate renal and hepatic functions, such as:

  * Leukocytes ≥ 2,800 and ≤ 11,300 cells/mL
  * Hemoglobin ≥ 10.0 g/dL
  * Platelets ≥100,000/mm3
  * Serum creatinine ≤ 2.5 upper limit (UL) of the laboratory
  * Total bilirubinemia ≤ 2.5 x UL
  * ALAT ≤ 2.5 x UL
  * Negative urinary strip: absence of leucocyturia, hematuria, and proteinuria (in case of positivity, a second urinary strip test will be made, for confirmation)

Exclusion Criteria:

* Participation in any study other than purely observational, in the 4 weeks preceding this study (determined by the theoretical date of administration of MOX-2 mg or IVM).
* Person who has taken IVM in the last 6 months
* Any vaccination in the 4 weeks preceding this study
* Acute infection requiring a treatment in the 10 days preceding this study, determined by the anamnesis during the medical interview (example: pulmonary infection, ENT, digestive, cutaneous, with implementation of an antibiotic treatment or not)
* Long-term antiretroviral therapy (protease inhibitor, non-nucleoside reverse transcriptase inhibitor), or treatment with ampicillin or chloramphenicol within 10 days prior to administration of the test drug
* History or presence of neurological (including epilepsy) or neuropsychiatric disease
* Excessive consumption of alcohol or other drug abuse within 72 hours prior to the administration of the test treatment determined by the medical history during the medical interview.
* Any condition, in the opinion of the investigator, which exposes the subject to an undue risk
* Subjects who donated blood in the 8 weeks prior to study entry, with a standard volume (\> 500 mL)
* Known intolerance to IVM, MOX or any of the excipients (including placebo)
* During the clinical examination: symptoms, physical signs or biological constants suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, cutaneous, immunodeficiency, psychiatric disorders and other abnormalities likely to interfere with the interpretation results of the test. The doctor may then give a favorable or unfavorable opinion for the inclusion of the participant
The Recovery Time of Quadriceps Strength After Total Knee Arthroplasty (TKA): The Effect of Quadriceps Incision Length

Minimally invasive total knee arthroplasty (MIS-TKA) became the popular technique. It had the less postoperative pain and shorter recovery time compared to the conventional technique. With using MIS technique, less cut of quadriceps tendon was the key. It related to keep more quadriceps strength and improve functional performance after TKA. However, there was no previous studies about the effect of quadriceps incision length in the recovery time of the quadriceps strength. The investigators hypothesized that longer quadriceps incision affected the longer recovery time of quadriceps strength in MIS-TKA.


Eligibility Criteria:
Inclusion Criteria:

* The patients who diagnosed primary osteoarthritis of knee with

  1. varus or valgus deformity \< 20 degrees
  2. preoperative range of motion \> 90 degrees
  3. extension lag \< 10 degrees
  4. Flexion contracture \< 30 degrees

Exclusion Criteria:

* Bilateral simultaneous total knee arthroplasty
* Previous knee surgery
* Inadequate exposure during the surgery
Erythrocyte and Adipocyte G6PD Activity Levels in Obesity

This study compares the improvement of weight, fasting lipid profile (triglycerides, cholesterol, HDL, and LDL) and diabetes after gastric bypass surgery with an improvement in levels of an enzyme called glucose-6-phosphate dehydrogenase (G6PD).

Same as brief summary

Eligibility Criteria:
Inclusion Criteria:

* Age \> 19 years of age and \<70 years of age
* HGA1c\<6.0%
* fasting blood sugar less than 100mg/dL

Exclusion Criteria:

* Taking antidiabetic medications for other indications
Radial Artery Access

This is an imaging investigation to assess the factors effecting radial artery diameter:

* Patient demographics
* Diameter change post standard care preparation

There are significant benefits to radial access intervention, namely superior mortality and morbidity Vs femoral access. In addition, there is significant patient preference and reduced nursing time post procedure in comparison to femoral access supporting day case practice.

Interventional oncology routinely involves repeated procedures therefore patient preference is a key factor in access choice. This again supports day case practice with significant patient preference also noted.

The clinical application of the study is to allow a broader spectrum of procedures to be performed via radial access. Currently due to a limited data available on factors effecting radial artery diameter practice there is a restriction on sheath size use. This limits the procedures that can be performed via this route. By assessing the diameter and factors which increase the vessel, larger access sheaths can be used opening up the procedure portfolio including neuro-interventional procedures and coeliac axis stenting. This will allow these procedures to be performed with added benefits of improved mortality/morbidity in addition patient preference.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or over
2. All patients undergoing Radial Artery Access requiring interventional radiology.

Exclusion Criteria:

1. Prior history of radial artery occlusion
2. Prior history of stroke
3. Need for future dialysis access creation or preservation of upper extremity vasculature for patients with chronic kidney disease
Study of Surgical Mesh for Inguinal Hernia Repair

The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* male ≥19 years old
* symptomatic and palpable inguinal hernia
* candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
* will comply with required follow-up study visits
* willing and able to provide written informed consent

Exclusion Criteria:

* BMI ≥35
* life expectancy of \<3 years
* strangulated hernia
* urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
* active abdominal surgical condition such as bowel obstruction or perforation
* local or systemic infection or peritonitis
* known disease that impairs wound healing
* anti-platelet therapy (other than aspirin) for \>7 days preceding the surgical procedure
* previous ipsilateral groin incision
* receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
* uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
* advanced cirrhosis with Child-Turcott Class of C or higher
* severe COPD requiring home oxygen
* diagnosed with chronic pain syndrome or is undergoing treatment for pain management
* candidate for another major surgical procedure with the inguinal hernia repair
* enrolled in another investigational study that may confound the results of this study
* known drug abuser
* on anti-psychotic medications
* Worker's Compensation case