cyrilzakka/clinical-trials huggingface dataset:
Combining Nutrition Supplementation With an Exercise Program in Elderly Malnourished Frail Patients After Hospital Stay

The objective of this study is to investigate the feasibility of a combined nutritional and home-based exercise intervention in elderly, malnourished, frail patients after hospital discharge.

Adherence to exercise program, adherence to oral nutrition supplement, potential inhibiting factors to follow exercise program, changes in nutritional status, muscle mass and function, quality of life are outcome factors.

The intervention consists of 12 weeks with a physical exercise program (vivifrail) and oral nutritional supplementation (Moltein Plus).

The investigators hypothesize that 12 weeks of a combined nutritional and home-based multicomponent exercise program is feasible for frail elderly patients after hospital discharge, meaning that ≥70% of the exercise sessions will be completed and oral supplements will be consumed by the participants.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* Malnutrition: Nutrition Risk Screening ≥3
* Frail/pre-frail status according Fried Frailty Phenotype: 1-2 criteria present = pre frail, \> 2 criteria present = frail
* Frailty status according to SPPB: A: 0-3 points = disabled, B (B+): 4-6 points = frail (at risk of falls), C (C+): 7-10 points = pre-frail (at risk of falls), D: 10-12 points = robust.
* Ability to sit
* Consent to participate in the study
* Ability to follow the instructions of the vivifrail program
* Prescription for use of an ONS

Exclusion Criteria:

* Severe acute cardiovascular issues: eg. unstable angina pectoris, uncontrolled arrhythmia, uncontrolled arterial hypertension or unstable cardiovascular disease or other unstable medical condition.
* Persisting oedema and/or ascites
* Contraindication for the protein-rich ONS (e.g. cow's milk allergy, end stage renal disease without renal replacement therapy) or dysphagia for liquids
* non-removable plasters or bandages at feet or hands aggravating body impedance analysis (BIA), implanted defibrillation device
* Parenteral/tube feeding
* No access to telephone or severe hearing loss
* Terminal illness
* Hospitalized due to pulmonary thromboembolism
* Considerable cognitive impairment: Mini-mental score \< 18 or advice of healthcare professionals against inclusion due to cognitive or psychological reasons.
Evaluation of Changes to Skin Microbiome With Tape-Stripped Wounds

This single center, randomized, 15-day clinical trial is being conducted to assess the changes to the skin microbiome of induced wounds on the back in approximately 35 healthy adult subjects aged 18-55 years, with Fitzpatrick Skin Types I - III. Microbiome and skin physiology assessments will be completed.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18 to 55 years of age.
2. Fitzpatrick skin types I to III.
3. Must be able to comprehend and follow the requirements of the study
4. Avoid excessive sun exposure
5. Willing to refrain from topical product use on the back for the duration of the study.
6. Subjects must agree not to immerse their bandages in water for the duration of the study.
7. Male and female subjects with reproductive potential who agree to practice a medically acceptable form of birth control

Exclusion Criteria:

1. Excessively hairy back, acne, scars and pigmentation or nevi t
2. . Pregnant or Lactating, or planning on becoming pregnant;
3. . Known allergies or sensitivities to anesthetics, adhesive bandages, wound treatment products or tapes;
4. . Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
5. Participation in any other clinical study within 30 days of Visit 1;
6. . Subjects who have a health condition and/or pre-existing or dormant dermatologic conditions or who have clinically active bacterial, fungal, or viral skin infections or those who are susceptible to cutaneous infections
7. Subjects who report using prescription or OTC medication (oral or topical) that can make skin more sensitive or influence the skin (i.e. antibiotics, hormones, insulin, etc.)
8. Subjects receiving topical and/or inhaled medications that may alter or compromise the bleeding/healing process
9. Individuals with a history of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications and/or radiation
10. . Subjects with a known history of keloid or hypertrophic scar formation;
11. Subjects diagnosed with any blood clotting disorder;
12. Hyperthyroidism or hypothyroidism or with active or recently treated (within 1 year) skin cancer, or those in poor nutritional status; 13 Subjects taking oral Vitamin A derivatives such as Accutane, isotretinon, or using retinoic acid in the past 1 year or using topical Vitamin A derivatives in the 3 weeks prior to study start;

14. Subjects with clinically infected skin lesions; 15. Subjects with cracked or excoriated skin, or other skin problems. 16. Diabetes mellitus that cannot be controlled by diet alone (i.e. requires systemic medications for control); 17. Subjects with friable skin, at the discretion of the Investigator;
Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment

The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements.

Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure.

Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy.

The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner).

Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients after mastectomy.


Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years,
* Operated for a breast cancer by mastectomy with or without lymph node dissection, without immediate reconstruction,
* Capable of understanding the antalgic protocol,
* No contraindication to the local anesthesics,
* Social security affiliation,
* Signed informed consent.

Exclusion Criteria:

* Preoperative radiotherapy,
* Local infection,
* Contra-indication to the local anesthetic or to CCP,
* Contra-indication for the use of morphine,
* Contra-indication for the use of remifentanil,
* Addiction to opioid analgesics know or not,
* Allergy to local anesthetics,
* Hepatic or renal impairment grim known,
* Previous surgery on the operated breast,
* Pregnant women, or child-bearing potential, or lactating women,
* Patient deprived of liberty or under supervision of a guardian.
Spatiotemporal Characteristics and Multi-body Dynamics Modeling Information After ACL Rupture and Reconstruction

High incidence rate of knee osteoarthritis and gait analysis are important for early assessment of biomechanics. ACL injury is an ideal clinical model for studying knee osteoarthritis.

To clarify the mechanism between the biomechanical status of knee joint and the change of gait touch information, and to provide scientific basis for quantifying and evaluating the biomechanical status of knee joint in dynamic load-bearing state.

Purpose: To clarify the relationship between the normal and abnormal biomechanical status of the knee joint and the gait touch information, and to establish the biomechanical evaluation model of the knee joint during walking or jogging, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors. An automatic analysis and expert diagnosis system was established to evaluate the biomechanics of knee joint.

Methods: 50 young male (23-35 years old) healthy volunteers and 100 patients with unilateral simple ACL rupture who need surgical treatment were recruited, 150 subjects in total. Three tests were performed before surgery, at the end of the 24th and 48th weeks after surgery. All were tested with three-dimensional gait analysis, dynamic plantar pressure measurement and isokinetic muscle strength during walking, jogging, emergency stop and take-off, side cut.

Outcome evaluation indicators and statistical methods: Two-way ANOVA method of repeated measurement was used, the left and right sides and different rehabilitation time were used as the variables of repeated measurement: the biomechanics of the lower limb joint and the change of the biological characteristics of the gait touch information were analyzed. Three dimensional gait analysis and computer-aided analysis of gait touch information were used to study the changes of ACL rupture and reconstruction. Based on the information of gait touch, taking into account the comprehensive effects of sports parameters, individual attribute parameters and other factors, a biomechanical evaluation model of knee joint during walking or jogging is established, which provides the exact basis for quantifying the information of gait touch and evaluating the biomechanical state of knee joint after ACL rupture and reconstruction under dynamic load-bearing state, and establishes a clinical practical automatic analysis and expert diagnosis system of gait touch information to evaluate the biomechanics of the knee joint.

Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old
* Patients who have isolated ACL injury and receive ACL reconstruction surgery at Peking University Third Hospital.
* With isolated ACL injury (an ACL injury with no need for surgical repairs to other knee structures).
* All participants have no known disorders or diseases other than ACL rupture.

Exclusion Criteria:

* Female patients who are pregnant, or suspected pregnant, or in breastfeeding will be excluded from this study.
Resistance Training in Patients With Parkinson's Disease.

This is a controlled trial to assess the effects of resistance training on bradykinesia and physical function in patients with Parkinson's Disease. Forty patients diagnosed with Parkinson Disease stage 1 to 3 of the Hoehn and Yahr scale took part in the study and were allocated into 2 groups; Training Group performed a 9-week RT program twice a week while the Control Group attended lectures on the disease.


Eligibility Criteria:
Inclusion Criteria:

* Medical neurologist confirmation of 1-3 Hoehn and Yahr stages,
* age between 50 and 80 years old;
* and physician attested to participate in the resistance training program.

Exclusion Criteria:

* Diagnostic of any other neurological disease, cardiovascular disease, hematologic or orthopedic disorders;
* and motor fluctuations or severe dyskinesia that could affect their ability to perform the experimental protocol.
Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients

Hypotension does not occur with Maraviroc at a dose of 600 mg/day

A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Epzicom Maraviroc once daily dosing

Exclusion Criteria:

* Maraviroc with any other back bone
Quality of Life and Neurodevelopment Assessment of Children With Congenital Heart Disease Aged 2 to 4 Years

Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Nowadays, health-related quality of life (HRQoL) assessment of this population is in the foreground. Our team is a tertiary care center for management of patients with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on HRQoL in pediatric and CHD. The investigators thus demonstrated the link between cardiopulmonary fitness and HRQoL in children with CHD aged 8 to 18 years, the correlation between functional class and HRQoL in adults with CHD, the impact of therapeutic education on HRQoL in children under anticoagulants and the lack of difference between the HRQoL of children CHD aged 5 to 7 years old and that of control children. Currently, no controlled cross-sectional quality of life study assessment has been leded in the youngest children with CHD. This present study therefore extends our work in younger children aged 2 to 4 years.

248 patients will be enrolled in this study (124 children in each group).

Patients from group 1 will be included during their annual medical check-up. HRQoL questionnaire, neurodevelopmental status scale and clinical status will be assessed during this site visit. No supplementary visit, directly related to the research, will be necessary. Three sites will participate to the study, members of he French national network for complex congenital heart diseases (M3C) .

Participants (healthy children) from group 2 will be included from kindergartens and schools. The prior agreement of the Ministry of National Education will be obtained before any procedure related to this study.

Eligibility Criteria:
Inclusion criteria:

* Children aged 2 to 4 years old.
* Group 2 : Chldren with CHD (as defined in the ACC-CHD classification).

Exclusion criteria:

* Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, severe genetic disease).
* Surgical procedure during the last 6 months.
* Inability to understand the HRQoL questionnaire (parents) :non-french speaker, severe intellectual disability.
Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 in Healthy Subjects

Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

A Dose-randomized, Double-blind, Placebo-controlled, Single- and Multiple-dose, Dose-escalation, Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Characteristics of JP-2266 after Oral Administration in Healthy Male Caucasian Subjects

Eligibility Criteria:
Inclusion Criteria:

* Healthy male Caucasian subject aged 18 to 50 years inclusive
* Body Mass Index (BMI) between 18 and 27 kg/m2 inclusive and body weight ≥ 50 kg at screening
* Signing a written informed consent prior to selection;

Exclusion Criteria:

* Any history (including family history) or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease;
Efficacy and Tolerability of Anacetrapib Added to Ongoing Lipid-Lowering Therapy in Adult Participants With Homozygous Familial Hypercholesterolemia (HoFH) (MK-0859-042)

This study will evaluate the safety and effect of anacetrapib on low-density lipoprotein-cholesterol (LDL-C) when added to ongoing lipid-lowering therapy. The primary hypothesis is that treatment with anacetrapib 100 mg for 12 weeks will lower LDL-C to a greater extent than treatment with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HoFH by genotyping
* If female, cannot be of reproductive potential
* Have been stabilized on statin monotherapy or statin therapy coadministered

with other lipid medications for at least 6 weeks

Exclusion Criteria:

* Severe chronic heart failure defined by New York Heart Association

(NYHA) Classes III or IV

* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary arterial by-pass graft (CABG), unstable angina or stroke within 3 months prior to Visit 1 or has planned procedures scheduled within first 12 weeks of study
* Uncontrolled endocrine or metabolic disease known to influence serum

lipids or lipoproteins

* Active or chronic hepatobiliary or gall bladder disease
* History of ileal bypass, gastric bypass, or other significant condition

associated with malabsorption

* Human immunodeficiency virus (HIV) positive
* Donated blood products or has had phlebotomy of \>300 mL within 8 weeks or intends to donate 250_mL of blood products or receive blood products within the projected duration of the study
* Taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A4), including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment \<3 weeks prior. Consumption of \>1 liter of grapefruit juice per day is also prohibited.
* Currently participating or has participated in a study with an investigational compound or device within 3 months
* Consume more than 2 alcoholic drinks per day
* Receiving treatment with systemic corticosteroids or systemic anabolic agents
Vitamin D Deficiency and Ovarian Reserve Among Infertile Patients

The role of vitamin D deficiency in female reproduction remains controversial. Early retrospective studies were inconsistent regarding the effect of serum 25-OH vitamin D levels on pregnancy rates in women undergoing in vitro fertilization (IVF), whereas two retrospective studies postulated that vitamin D deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium.

Taking into account that knock-out experiments have shown that vitamin D receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin D deficiency may have a detrimental effect on female ovarian reserve. This may be further supported by previous reports demonstrating that serum 25-OH Vitamin D levels correlates with antimullerian hormone (AMH) levels in women of advanced reproductive age.

The aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-OH-Vitamin D levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum AMH levels and antral follicle count (AFC).


Eligibility Criteria:
Inclusion Criteria:

infertile women less than 42 years old, undergoing their first treatment cycle in our institution

Exclusion Criteria:

vitamin D supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss
Short Course Radiation Treatment for Patients with Primary or Locally Recurrent Retroperitoneal Sarcoma Prior to Surgery

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

To determine the safety of moderately hypofractionated radiation in the treatment of primary and locally recurrent RPS, based on the evaluation of acute radiation-related toxicity profile of each participant (30-day radiation toxicity)

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a histologically confirmed STS of the retroperitoneal space or infra-peritoneal spaces of pelvis
* Participant must have radiologically measurable disease (RECIST 1.1), as confirmed by abdomino-pelvic CT or MRI
* Participant must have primary, locally recurrent, or metastatic disease requiring treatment of the retroperitoneal mass
* Tumor must be suitable for radiotherapy and surgery based on pre-treatment CT scan/MRI in multidisciplinary discussion with surgeon and radiation oncologist (anticipated macroscopically complete resection, R0/R1 resection)
* Age: 18 years or older
* ECOG performance status ≤2
* Absence of history of bowel obstruction, mesenteric ischemia, or severe chronic inflammatory bowel disease.
* Normal renal function (calculated creatinine clearance ≥50 mL/min)
* Normal bone marrow and hepatic function (white blood cell count ≥2·5 × 10⁹ cells per L, platelet count ≥80 × 10⁹ cells per L, and total bilirubin \<2 times upper limit of normal)
* Women of child-bearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
* Patients capable of childbearing/reproductive potential should use adequate contraception
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Sarcoma originating from bone structure, abdominal or gynecological viscera
* Any of the following histological subtypes: gastrointestinal stromal tumor, rhabdomyosarcoma, primitive neuroectodermal tumor or other small round blue cell sarcoma, osteosarcoma, chondrosarcoma, aggressive fibromatosis, or sarcomatoid or metastatic carcinoma
* Prior RT to the RPS
* Prior abdominal or pelvic irradiation for other prior malignancy or other disease
* Prior different invasive malignancy may be eligible per the discretion of the treating investigator and review by the Principal Investigator (PI)
* Prior chemotherapy or immunotherapy within 6 weeks of start of RT
* Pregnant women are excluded from this study because RT has the potential for teratogenic or abortifacient effects.
* HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for increased sensitivity to RT
Treatment of Colonic Obstruction With Cook Evolution® Colonic Stent System

The objective of this registry is to compile clinical data on the use of the Evolution® Colonic Stent System for the palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.


Eligibility Criteria:
Inclusion: per the IFU,

* colonic strictures caused by malignant neoplasms, and
* large bowel obstruction due to malignant strictures prior to colectomy.

Exclusion:

* central ischemia,
* any contraindication to GI endoscopy and any procedure to be performed in conjunction with stent placement,
* suspected or impending perforation,
* intra-abdominal abscess/perforation,
* inability to pass wire guide or stent deployment system through the obstructed area,
* patients for whom endoscopic or percutaneous procedures are contraindicated,
* benign disease, and
* coagulopathy.