cyrilzakka/clinical-trials huggingface dataset:
Clinical Pharmacology of FYU-981 (Subjects With Renal Insufficiency)

The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with renal insufficiency and with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Japanese adult subjects
* Body mass index: \>=18.5 and \<30.0

Exclusion Criteria:

* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study
Pilot Study Comparing Two Techniques of Taking Care Analgesic in Patients 70 and Older, Awaiting Surgery After Extracapsular Fracture of the Proximal Femur

The fracture of the proximal femur is a common traumatic pathology in patients aged over 70 years, associated with a mortality of 20 to 30% a year. The care is delayed emergency. During this wait, the occurrence of heel pressure ulcers is regularly found, despite wearing antiescarres slippers. Mobilization, source of pain, is also problematic.

759/5000


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 70 and over,
* Extracapsular fracture isolated from the proximal end of the femur,
* Informed consent of the patient for participation in the study,
* Patient affiliated to a social security scheme.

Exclusion Criteria:

* Restlessness or fragile skin condition that may prevent the establishment or maintenance of traction stuck preoperatively
* Insane or confounding Pathology,
* Predictable time before operation\> to 72 hours (eg anticoagulated patient orally before the fracture \[antiplatelet agents are allowed\], other associated diseases: urinary tract infection, pneumonia ...)
* Patient under guardianship, curatorship, or under judicial protection.
Early Recovery After Surgery (ERAS)/Prehabilitation - Randomized Controlled Trial on the Implementation of ERAS/prehabilitation in Elective Reconstructive Shoulder Surgery

The aim of this randomized controlled trial is to investigate whether the intervention can improve the clinical outcome and patient satisfaction in elective reconstructive shoulder surgeries. The study participants are adults with a diagnosed rotator cuff tear for which surgical treatment is planned. This main question is to be answered by the study:

• Does prehabilitation before elective shoulder surgeries lead to an improvement in postoperative outcomes and patient satisfaction compared to the control group?

The control group receives standard information about the hospital stay, while the intervention group undergoes the prehabilitation program in the approximately 6 weeks prior to surgery. This program includes:

* Information on the condition and pain management
* Recommendations for behavior modification
* A home exercise program Primary endpoint is the Western Ontario Rotator Cuff Index (WORC). The assessments are conducted at four time points: at study enrollment, immediately before surgery, and at 6, 12, and 24 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a traumatic or degenerative rupture of the rotator cuff with whom surgical treatment has been discussed in the shoulder clinic.

Exclusion Criteria:

* Pre-existing fracture of the upper arm or shoulder girdle, rheumatic arthritis/fibromyalgia, additional findings in the shoulder joint (instability, frozen shoulder), neurological disease, cognitive or speech impairment
Docetaxel, Gemcitabine and Bevacizumab for Metastatic Breast Cancer

This study will evaluate the efficacy and toxicity of docetaxel, gemcitabine and bevacizumab combination, administered biweekly, as salvage treatment in patients with metastatic and HER2 negative breast cancer.

Docetaxel plus gemcitabine is an active combination in the salvage treatment for metastatic breast cancer. Administered every two weeks, this combination has a favorable toxicity profile, and promising activity in \> 1st line treatment for metastatic breast cancer. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone. This study will evaluate the addition of bevacizumab to a biweekly regimen of docetaxel and gemcitabine in the salvage therapy for metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically- or cytologically- confirmed metastatic breast adenocarcinoma
* No HER2 overexpression or gene amplification
* At least one previous chemotherapy regimen for metastatic breast cancer
* Age ≥18 years
* Performance status (WHO) 0-2
* Life expectancy of at least 12 weeks
* Measurable disease as defined by at least 1 bidimensionally measurable lesion ≥ 20 X 10 mm
* Performance status (WHO) 0-2
* Adequate liver function (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases), adequate renal function (serum creatinine \<1.5 times the upper normal limit) and bone marrow ≥ 1,500/mm3, PLT ≥ 100,000/mm3, Hgb ≥ 9 g/dL) function
* Written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Progressive brain metastases according to clinical or radiological criteria
* Brain metastases without prior radiation therapy
* Radiation therapy within the previous 4 weeks
* Previous radiation therapy to the only measurable lesion
* Proteinuria ≥ 500 mgr of protein daily
* Uncontrolled hypertension
* Documented hemorrhagic diathesis or coagulation disorder
* Cardiovascular disease (class II-IV NYHA congestive heart failure, myocardial infarction within the previous 4 months, unstable angina, LVEF \< normal, ventricular arrhythmia, uncontrolled hypertension)
* Thrombotic event within the previous 6 months
* Concurrent use of aspirin \> 325 mgr daily, low molecular weight heparin in therapeutic dose, warfarin or acenocoumarol, non-steroid anti-inflammatory agents
* Major surgical procedure within the previous 4 weeks
* Presence of nonhealing wound or fracture
* Peripheral neuropathy \> grade 2 according to the NCI CTCAE (version 3.0)
* Any sustained chronic toxicity \> grade 2 according to the NCI CTCAE (version 3.0)
* Uncontrolled infection
* Any serious, uncontrolled comorbidity on the investigator's judgment
* Other cancer within the previous 5 years, except non-melanoma skin cancer and in situ cervical cancer
* Serious psychiatric illness
Influence and Relationships Between Square-stepping Exercise and Brain Activation, Cognitive Function, Physical Performance in Healthy Older Adults

Background and purposes: Square-stepping exercise (SSE) has been proved to be an effective intervention for motor and cognitive function in older adults. However, the underlying mechanism of SSE still remains undetermined. Therefore, the aim of this study is to elucidate the possible mechanism of SSE in healthy older adults.

Methods: This is a cross-sectional study. Inclusion criteria are: (1) age between 65 and 90 years, (2) no frailty indicated by Fried frailty criteria, (3) mini-mental state examination score≧24 and Montreal Cognitive Assessment score≧26, (4) ability to walk independently for 1 min. Brain activation differences between SSE patterns and usual walking, as well as relationships between brain activity, cognitive function, physical performance and SSE performance will be examined. This study will address both cognitive and motor aspects of possible mechanism in SSE. SPSS version 25.0 (SPSS Inc., Chicago, IL, USA) will be used to analyze the collected data in this study. One-way ANOVA with repeated measures is used to evaluate the differences in brain activation among usual walking, SSE-pattern 1, and SSE-pattern 2, with Bonferroni test for post hoc analysis. The Pearson correlation coefficient will be used to establish the relationships between brain activity and SSEs performance, between cognitive function and SSEs performance, and between motor function and SSEs performance. The significant level is set at p\< .05.


Eligibility Criteria:
Inclusion Criteria:

* Age between 65 and 90 years
* No frailty indicated by Fried frailty criteria
* Mini-mental state examination score equals to or more than 24, and Montreal Cognitive Assessment score equals to or more than 26
* Ability to walk independently for 1 min

Exclusion Criteria:

* Central nervous system disorders (such as stroke, Parkinson's disease, spinal cord injury)
* Any unstable physical condition, psychiatric disorder, and other neurological disorder, or diagnosed with learning disability which may affect participating this study
Can Subclavian / Infraclavicular Axillary Vein Collapsibility Index Predict Post-Spinal Hypotension in Caesarean Section Operations?

Postspinal hypotension (PSH) is a common side effect with an incidence of 15.3% to 33%, which may result in organ hypoperfusion and ischemic events (1,2). In pregnant patients, this incidence may increase to 70% and severe PSH may increase the risk of maternal and fetal complications (3). Therefore, it is important for anesthesiologists to estimate the incidence of PSH in cesarean sections and to identify possible mechanisms (4).

One of the important factors affecting the susceptibility of patients to intraoperative hypotension is the preoperative intravascular volume status. Recently, ultrasonography of the central veins has been used frequently by anesthesiologists in the preoperative period in order to evaluate the intravascular volume status (5). Salama and Elkashlan stated that the collapsibility index of the inferior vena cava is a new predictive value for PSH (6). Choi et al. showed that the subclavian vein or infraclavicular axillary vein collapsibility index is an important predictive value for hypotension after induction of general anesthesia (7).

In this study, we wanted to investigate whether the subclavian vein or infraclavicular axillary vein collapsibility index can be used as a predictive value for PSH in cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Spinal anesthesia
* ceserean operation
* American Society of Anesthesiologists' (ASA) physical status I-II

Exclusion Criteria:

* Patients who underwent cesarean section in emergency conditions
* Patients who underwent cesarean section under general anesthesia
* American Society of Anesthesiologists' (ASA) physical status III-IV
Breastfeeding Intervention Study

To evaluate the benefits of a lactation support intervention, in conjunction with maternal nutritional supplementation.

This study aims to evaluate the benefits of a lactation support intervention model combining a maternal nutritional supplementation starting at 8 weeks before delivery to 12 weeks postpartum and a lactation support intervention consisting of 1 prenatal and 3 postnatal sessions on exclusive breastfeeding rate.

Eligibility Criteria:
Inclusion Criteria:

1. Mother with singleton pregnancy at 26 to 29 weeks of gestation.
2. Mother is between 20 and 35 years of age.
3. Mother pre-pregnant BMI \< 25.0 kg/m2.
4. Mother is first-time mother.
5. Mother is contactable by telephone.
6. Mother is non-smoker.
7. Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
8. Infant's birth weight was \> 2500 g.
9. Infant is judged to be in good health.
10. Mother confirms her intention to breastfeed and refrain from taking any other nonstudy maternal milk supplement or galactogogues during the study period.

Exclusion Criteria:

1. Mother is allergic or intolerant to any ingredient found in the study product.
2. An adverse maternal, fetal or infant medical history that has potential effects on child's growth and/or development.
3. Mother has gestational diabetes and/or pre-eclampsia.
4. Mother with contraindications to breastfeeding.
5. Gestational weight gain is greater than 14 kg at enrollment.
6. Mother had a breast surgery.
7. Mother and/or newborn infant has major illness that requires intensive care admission.
8. Infant has major congenital anomaly.
Emotional Bodymaps in Pediatric Pain Patients and Their Parents.

The aims of this study are to find out how pain may alter the experience of emotions in the body in pediatric pain patients and how how their parent feel the emotions in their bodies. We are also interested how this possible effect is mediated by the duration and location of pain, mood changes or with the experience of bullying.


Eligibility Criteria:
Inclusion Criteria:

* fluency in finnish language

Exclusion Criteria:

* none
Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

The aim of this study is examining the combination of two FDA approved drugs, Opipramol and baclofen, which may increase rehabilitation from psychoactive substances. Previous studies have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility that these receptors as mediators of drug craving . However previous studies showed partial efficacy with no significant relapse in relapse rates. The same is true for the use of GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal model for addiction have shown a significant effect of the combine treatment of the indicated medications both in decreasing relapse and increase of -number of respondents.


Eligibility Criteria:
Inclusion Criteria:

* Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials

Exclusion Criteria:

* Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).
Efficacy and Safety of GV 550 in Acute Adenovirus Keratoconjunctivitis

The study objective is to evaluate the efficacy and the safety of GV 550 in comparison to placebo in patients with acute adenoviral keratoconjuncivitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or female aged from 18 to 80 years old
* Acute adenoviral keratoconjunctivitis

Exclusion Criteria:

* Active ocular allergy
* Ocular herpès disease
* History of bacterial conjunctivitis / blepharoconjunctivitis within the last month before the inclusion visit
Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients (EXACTLE)

The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.

This is a one to one randomized, placebo-controlled, clinical, exploratory study with the aim of collecting information on possible clinical endpoints i.e., the progression of emphysema by lung density measurements with CT scan and frequency of exacerbations that could be used for a subsequent placebo controlled clinical trial. Progression of disease will be investigated in 80 patients with alpha-1-antitrypsin deficiency, who will be treated with human alpha-1-antitrypsin (AAT; Prolastin®) or placebo weekly for two years to analyze the effect of treatment on lung density and exacerbations. Targeted augmentation therapy with weekly infusions of Prolastin® will be a dose of 60 mg/kg body weight (range of 51.72 to 71.43 mg per kg body weight).

Therefore, this study focuses on several questions:

* Is the 15th percentile point calculated by analysis of CT lung histograms a useful endpoint for clinical trials in AAT deficiency?
* Is quantitation of exacerbations in AAT-deficient patients a useful endpoint for clinical trials in AAT deficiency?
* Are there significant differences between the treatments in favor of Prolastin®?

Eligibility Criteria:
Inclusion Criteria:

* Patient with pulmonary emphysema due to severe congenital AAT deficiency of phenotype protease inhibitor Z (PiZ) or other rare genotypes (not MS, MZ or SZ) and AAT serum level \< 11 microns (µM) or \< 80 mg/dL (status to be confirmed by phenotyping and genotyping)
* Inspiratory capacity (VC - ERV) \> 1.2 L and forced expiratory volume at one second (FEV1) \< 80% of predicted value post bronchodilator
* FEV1/VC \< 70% of predicted value post-bronchodilator or transfer factor of carbon monoxide (KCO) \< 80% of predicted value post-bronchodilator
* History of at least one exacerbation in the past 2 years
* Written informed consent

Exclusion Criteria:

* FEV1 \< 25% of predicted value post-bronchodilator
* Augmentation therapy for more than one month with plasma-derived human alpha 1-antitrypsin (AAT) within the last 2 years
* History of lung transplant
* Any lung surgery within the past 2 years
* On any thoracic surgery waiting list
* Diagnosis of liver cirrhosis
* Severe concomitant disease
* Active pulmonary infection/exacerbations within the last month
* Active smoking during the last 6 months or plasma positive for cotinine
* Body weight \< 42 kg or \> 92 kg
* Pregnancy or lactation
* Women of child-bearing potential without adequate contraception
Effect of Foot Insole on Body Alignment, and in Stroke Patients

Goal: This study will be conducted to find out the effects of customized insole on foot alignment, body alignment, and balance ability of stroke patients.

Recruitment: Total 20 participants will be recruited and will be divided into 2 groups: Intervention and control group with or without wearing foot insole for 6 weeks.

Evaluation tool:

1. MediACE Scanner-MS320F will be used to evaluate foot alignment and will create customized insole.
2. Exbody 770 will be used to measure body alignment.
3. Timed up \& go test will be used to evaluate dynamic balance.

Intervention: The intervention group will wear a customized insole during daily life for 6 weeks whereas the control group will not.

Evaluation will be conducted 2 times before and after 6 weeks.

This study will recruit 20 stroke patients and will randomly assign them to the intervention group (n=10) and control group (n=10). After given the full description of the study, participants who will voluntarily agreed to participate will be included.

This study involves producing customized insoles for participants to wear during daily activities for six weeks. The customized insoles will be produced using the MediAce Scanner-MS320F, which scans the participants' feet in a seated position.

The participants in the intervention group will wear the produced insoles during daily activities. Their rehabilitation program will be continued apart from the insole wearing.

The participants in the control group will wear their normal insoles during daily activities. Also, their rehabilitation program will be continues as same as the intervention group.

Outcome measure will be conducted twice, pre- and post-intervention. It includes foot alignments and arch height using the MediACE Scanner-MS320F, body alignments using the Exbody 770, and balance ability using the Timed Up \& Go test.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (more than 1 year ago) stroke patient over 50 years old
* MMSE (mini-mental state examination) score of 24 or higher out of 30, capable of understanding the experimenter's instructions
* No history of orthopedic surgery
* Voluntarily agreed to participate

Exclusion Criteria:

* Neurological problems other than stroke affecting balance ability
* Movement restrictions or involuntary limb movements due to ankle pain
* Severe visual impairment, field defects, cognitive impairment making it impossible to use evaluation equipment
* Taking medication affecting posture and balance ability
Effects of Zoledronic Acid Versus Alendronate on Bone Loss After Kidney and Kidney/Pancreas Transplants

The study is designed to look at the effect of different bone treatment plans on bone loss after kidney or kidney/pancreas transplant.

The aims are to determine baseline bone mineral density (BMD) in kidney and kidney/pancreas transplant patients who will be randomized to weekly alendronate, annual zoledronic acid infusions or placebo (calcium with Vitamin D). These patients will be followed for two years with annual bone density testing as well as biochemical markers. A secondary aim is to evaluate the compliance.

Eligibility Criteria:
Inclusion Criteria:

* Transplant patients who have had a kidney or kidney/pancreas transplant in the last 150 days with adequate kidney function as defined by a calculated creatine clearance of 35ml/min or more and serum creatinine less than 3.0

Exclusion Criteria:

* Dual X-ray Absorptiometry (DXA) T-score at the spine or hip of -3 or lower
* History of more than one vertebral or non-vertebral fracture in the past two years
* Abnormalities of the esophagus which delay esophageal emptying
* Inability to stay upright for 30 minutes
* Pregnant, nursing women or women not using an effective form of birth control
* Hypocalcemia
* Hypercalcemia
* Calculated creatinine clearance of \<35 ml/min or serum creatinine \> 3.0
* Patients already treated with bisphosphonates within the past one year
* Patients unable to undergo DXA
* Patients with cancer