cyrilzakka/clinical-trials huggingface dataset:
Impact of Prolonged Physical Therapy on Gait Performance of Chronic Phase Stroke Patients

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months.Following the initial screening, subjects will be randomized into two groups: one who continues attending two physical therapy sessions per week for two months, or the other one who stops physical therapy sessions for two months. Before and after those two months, a 3 days recording will be made using an ambulatory system called TRIDENT.

The aim of this multi-center, randomized controlled study is to acquire and compare information on gait performance in patients with chronic hemiplegia (six months to two years post-stroke) who either continue to attend two physical therapy sessions per week for two months or who stop physical therapy sessions for two months. This will permit us 1) to assess the efficacy of continuing physical therapy sessions during the chronic phase of post-stroke hemiplegia, 2) to investigate whether the effects of physical therapy in these patients gradually decreases during the period of six months to two years post-stroke, and 3) to model the relationship between standard measures of gait performance (speed, endurance, balance, use of technical aids...) with other multidimensional covariates: social and environmental factors (type of housing, presence of a third person,...), cognitive factors (cognitive disorders associated) and thymic factors (anxiety, depression) and 4) to assess the costs associated with the physical therapy care of chronic-phase stroke patients .

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged 18 to 75 years, with a first ischemic or hemorrhagic stroke at least six months ago and no longer than two years ago, without subsequent stroke. It must have caused initially complete hemiplegia of the right or left hemibody, but they must be able of walk alone with or without technical assistance over a distance of at least 10 meters They must be able change direction too.
* Finally, they must have a Functional Ambulation Classification (FAC) score between 4 and 6 during the inclusion.

Exclusion Criteria:

* We will exclude patients with a neurological history other than a stroke, a psychiatric illness, or an associated debilitating disease.
* They must not have an associated cerebella syndrome or a clinical brainstem attack.
* We will refuse patients who are pregnant, who have not signed the written consent, and who aren't entitled to a social security scheme.
Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

In this study, investigators aimed to develop and validate a risk score to predict severe outcomes (e.g., mortality and ICU admission) in children who were admitted to the Children's Hospital of Fudan University between 2017 and 2022 due to community-acquired pneumonia (CAP). The objectives were as follows.

1. Develop a risk prediction model based on demographic, comorbidity, clinical characteristics, laboratory data, and chest radiographic reports to predict severe outcomes among children hospitalized with CAP;
2. Develop a risk scoring system and determine the cut-off point;
3. Externally validate the easy-to-use risk score.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 29 days and 18 years old;
2. Admitted to hospital with signs or symptoms of acute infection (eg, fever) and acute respiratory illness (eg, cough), and radiographic evidence of pneumonia.

Exclusion Criteria:

1. Pneumonia developed 48 hours after admission or intubation;
2. Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.
Study Assessing Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MGTA-145 in Healthy Volunteers as a Single Agent or in Combination With Plerixafor

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in healthy volunteers as a single agent and in combination with plerixafor.

The study consists of up to four parts: Part A, to investigate the safety and tolerability of MGTA-145; Part B, to investigate the safety and tolerability of MGTA-145 when administered in combination with plerixafor; Part C, to investigate the safety and tolerability of two sequential days of dosing MGTA-145 in combination with plerixafor; and Part D, to investigate the safety, tolerability, and measure by apheresis, the total number of CD34+ cells mobilized after a dose of MGTA-145 administered in combination with plerixafor.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 60 years
2. Body weight ≥50 kg and body mass index 19 to 33 kg/m2
3. No clinically significant abnormalities on physical examination at Screening
4. Non-smoker for at least 2 years
5. No clinically significant lab abnormalities for renal, hepatic or hematologic parameters
6. No clinically significant abnormalities on ECG
7. Female subjects must be of non-childbearing potential
8. Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or those who are sexually active with a female partner(s) and agree to use an acceptable method of contraception
9. No contraindications for apheresis

Exclusion Criteria:

1. Any clinically significant laboratory value outside the normal range at screening
2. Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing
3. History of alcoholism or drug abuse within the past 3 years
4. Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non-prescription drugs within 7 days prior to dosing
5. Acute illness, infection (requiring medical treatment \[eg, antibiotics\]), or surgery within 4 weeks of dosing
6. Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus
7. Subject has received another investigational drug or participated in an investigational drug or device study within 12 weeks prior to dosing
8. History of anaphylaxis or clinically important reaction to any drug including plerixafor
9. Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, renal, hepatic, or gastrointestinal conditions
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns

This research proposal is introduced to clinically test short fiber reinforced flowable resin composite material (everX Flow, GC Europe) as a supporting base under CAD/CAM resin composite endocrowns due to gap of knowledge present in this area.


Eligibility Criteria:
Inclusion Criteria:

* Endodontically treated molar teeth indicated for endocrown.
* Presence of favorable occlusion and teeth are in normal alignment with the adjacent teeth, -medically free

Exclusion Criteria:

* ▪ Endodontically treated molar teeth indicated for post and core or only crown coverage.

  * Severe periodontal problems
Clinical and Biological Digestive Peritoneal Carcinomatosis Data Base From the French National Network of Peritoneal Surface Malignancies

To access to good quality biological samples is a prerequisite for high level translational research. The BIG-RENAPE study has been established by the French hyperthermic intraperitoneal chemotherapy centers involved in the management of peritoneal surface malignancies.

The main BIG-RENAPE study aim is to create a large multicentric and prospective repository for biological and tissue samples, which will provide a source of materials for a wide array of health related research studies - BIG-RENAPE Biobank-based research: i) validating known and promising biomarkers; ii) identifying new predictive and prognostic factors; iii) evaluating the impact of current health care strategies; iv) standardizing diagnostic and therapeutic management through guidelines; v) developing new drugs.

The BIG-RENAPE Biobank is certified according to NFS 96-900 as a service of processing, storage and transfer of high quality biological (plasma, serum, buffy coat) and tissue (formalin-fixed-paraffin-embedded) samples. Biospecimens are collected at each stage of diagnostic and therapeutic care. The patient and his derivates are anonymized and registered in a national web database reporting disease status, treatments, surgical procedures, pathological diagnosis, quality of life's assessment and long term follow-up. All participants have given their informed consent before any sample. The BIG-RENAPE study was approved by the local Ethical Committee, based on the assessed compliance to French regulatory rules.


Eligibility Criteria:
Inclusion Criteria:

* Men / women aged over 18 years
* Patients with cancer management and care for peritoneal carcinomatosis of digestive origin
* Patients had histologic/radiologic confirmation of peritoneal disease
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research;
* Ability of participants to give their informed consent

Exclusion Criteria:

* Minor patient
* Adult unable to consent
* Patient refusal to participate in the study
Retrograde Reperfusion Versus Antegrade Liver Transplant Reperfusion

A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion.

A retrospective cohort analysis was performed comparing patients that had intra operative antegrade liver reperfusions versus patients that had retrograde liver perfusion. Antegrade Reperfusion(ATR) group: after completing the caval replacement or piggy-back, for IVC anastomosis, Portal vein (PV) anastomosis was done with a running suture as normal fashion, then it was followed by the removal the clamps, starting by the supra hepatic VC, followed by the PV clamp and finally the infrahepatic VC. It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible). Retrograde group (RETR): after completing the piggyback the IVC was declamped immediately and retrograde low pressure reperfusion of the graft with low oxygenated venous blood was established. Central venous pressure was intended to be higher than in 8 mmHg to enable appropriate retrograde reperfusion in the transplanted liver. Significant venous backflow via portal vein appears immediately after declamping. Venous bleeding from the liver except portal backflow was stopped immediately after declamping the venous anastomosis, as appropriate. Portal vein anastomosis was performed using running suture. It was followed by arterial anastomosis and the biliary anastomosis (duct-to-duct if possible). The endpoints are patient survival and graft survival at 1, 3,5, 10 years post liver transplantation in both groups. To adjust for a selection bias, we will perform a propensity score analysis.

Eligibility Criteria:
Inclusion Criteria:

* all liver transplantations between 1 Jan 2002 and 31 Dec 2005

Exclusion Criteria:

* liver retransplantation
* multiorgan transplantation
* ABO incompatible transplantation
Long Term Safety Assessment of SER120 in Patients With Nocturia

The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
* Willing to provide consent for the study

Exclusion Criteria:

* Incontinence
* Diabetes Insipidus, Diabetes Mellitus
* CHF
* Renal Insufficiency
* Significant medical history which make participation unacceptable
Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae

The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.


Eligibility Criteria:
Inclusion Criteria:

* Deep, uncannulatable, upper extremity arteriovenous fistula
* Minimum arteriovenous fistula flow 400 ml/min
* One year life expectancy

Exclusion Criteria:

* Non-transposed basilic or brachial vein arteriovenous fistula
* History of peripheral vascular disease
* History of cardiovascular disease
* History of cerebral vascular disease
Resection vs no Resection of the Primary in Colorectal Cancer With Unresectable Metastases

Main outcome: Assess the impact of cancer-related survival at 2 years in patients with unresectable metastatic colorectal cancer treated with chemotherapy alone versus surgery followed by chemotherapy. To assess overall survival. To evaluate postoperative morbidity and mortality in patients treated with resection of the primary tumor. Assess complications and meed for surgery in patients treated with systemic chemotherapy only during the course of the disease. Identify and describe the complications related to chemotherapy and toxicity in the short and medium term systemic treatment. Assessing the quality of life questionnaire QLQ-C30 and QLQ-CR29. To study prognostic survival factors.

Method: multicenter randomized clinical trail (22 hospitals). Two parallel group in which to evaluate two therapeutic strategies for colorectal cancer metastasis unresectable stage IV: chemotherapy alone versus primary tumor resection plus chemotherapy.

Subjects: patients with unresectable nonmetastatic colorectal cancer. Hypothesis:Surgical resection of the primary tumor in stage IV colorectal patients with unresectable synchronous metastases increases by 14% overall survival compared to patients receiving systemic treatment with chemotherapy without resection of the primary tumor (survival of 34% vs 20%).

Intervention: Arm B (control): chemotherapy alone, regimen according to each center. Arm A (experimental): surgery (complete tumoral resection; R0) followed by chemotherapy, regimen according to each center. Statistical Analysis: A power analysis showed that to assure a significance level of 0,05 and a beta error 0.20. 168 patients are necessary in each arm. It has been estimated a loss rate of up to 10%.

Differences between groups will be analyzed by t, U, X2, exact test and survival will be assessed according to Kaplan and Meier method. Evaluation of safety of the trial will be made in the middle of the study statistically

Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer above to 12 cm from the anal verge
* unresectable synchronous metastases
* no contraindications for chemotherapy
* absence of peritoneal carcinomatosis, central nervous system o bone metastasis.
* performance status ECOG ≤ 2 (Eastern Cooperative Oncology Group)
* uncontrolled concomitant medical conditions that may compromise to chemotherapy
* significant symptomatic cardiac disease
* not pregnancy or breastfeeding

Exclusion Criteria:

* Cases of rectal tumours below 12cm from anal verge, or locally advanced tumours invading blood vessels, nerves or bone.
* Multiple bone metastasis or central nervous system metastasis
* Other neoplastic disease in the 5 previous years, except squamous or basal cell skin carcinoma or cervical "in situ" carcinoma
* Significant heart disease (chronic congestive heart failure, symptomatic coronary disease) or myocardial infarction in the previous 6 months
* Peripheral neuropathy
* Patients who do not give informed consent
Is Size of Cisterna Magna Related to the Fetal Gender and Gestational Age

The cisterna magna (CM) is a large subarachnoid cerebrospinal space that lies between the caudal aspect ofthe cerebellum and the medulla oblongata, drainingthe fourth ventricle . The evaluation of the fetal cisterna magna is animportant part of obstetric ultrasound which targetsdetection of prenatal malformation of the fetal centralnervous system (CNS).Therefore, measuring the size ofthe cisterna magna has important clinical significancefor diagnosing fetal nervous system abnormalities.

Studies about the relationship between the anteroposterior diameter of the CM and the gestational age (GA) are still controversial. Some articles havepointed out that there was a good correlationbetween the diameter of the CM and GA

Prospective study that will include pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation. As in cross sectional study each fetus is considered only once. with use of magnetic resonance ultrasonography.( ultrasonography is a noninvasive imaging test uses high-frequency sound waves to create real-time pictures or video of internal organs or other soft tissues)

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are between 20 weeks 0 days and 39 weeks 6 days of gestation.
* Singleton pregnancy.

Exclusion Criteria:

.gestational age can not be confirmed.

* Fetal malformations or intrauterine growthretardation
* Women with chronic diseases.
* bodymass index \>30
Pediatric Ilioinguinal / Iliohyogogastric Nerve Block

Ilioinguinal / iliohyogogastric nerve blocks; It is frequently used for analgesia and anesthesia in inguinal region surgeons. However, 95% of these surgeons are under general anesthesia. aim of this study; Intra-operative anesthesia and analgesia effects of ilioinguinal / iliohyogogastric nerve block supported by ketamine sedation only.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* To undergo elective lower abdominal surgery
* between 2-6 years old

Exclusion Criteria:

* Patients with psychiatric disease
* Patients whose weight is more than 40 kg
* Patients with cardiac-pulmonary-neurological disease
* Patients with bleeding disorder
* Patients with infection or scar on the injection area
* Patients with known allergies to local anesthetics
Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis

This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

This study will compare the use of inhaled concentrated sodium chloride solution to an inhaled solution of sodium bicarbonate in an attempt to decrease the thickness and stickiness of the mucus in the lungs of a person with cystic fibrosis. Also, this study is also looking at whether or not it is possible to decrease the acidity of the airways by inhaling sodium bicarbonate through nebulizer treatments.

Eligibility Criteria:
Inclusion Criteria:

1. FEV1 greater than 50% predicted.
2. Ability to spontaneously expectorate sputum (with or without chest physiotherapy).
3. Stable disease as defined by absence of exclusion criteria numbers 3-5 and clinician assessment.

Exclusion Criteria:

1. Reactive airway disease
2. Use of inhaled hypertonic saline in the past 28 days
3. Use of IV antibiotics in the past 4 weeks
4. Changes in CF-related medications in the four weeks prior to study screening
5. SpO2 \< 94% on room air or use of supplemental oxygen.
6. Presence of untreated gastroesophageal reflux disease (GERD) or residual acid reflux symptoms in cases of treated GERD more than three times per week.
7. Pregnant or nursing females.
Automated Diabetes Prevention Program

The objective for this pilot project is to determine the feasibility and effectiveness of the Interactive Voice Response protocol (IVR) on physical activity and eating behaviors in a group men and women who have been identified by their physician as being pre-diabetic. We hypothesize that participants receiving the IVR follow-up will have greater positive changes in their physical activity and eating behaviors when compared to those who receive only the standard-care pre-diabetes class.

Patients diagnosed with pre-diabetes present a unique opportunity for health care providers to implement preventive practices. Behavioral intervention strategies that target weight reduction or maintenance and increased fitness not only provide exceptional cardiovascular benefits, but also play an important role in delayed development or prevention of type 2 diabetes mellitus (DM). This study was designed to determine the feasibility and effectiveness of automated telephone support calls targeting physical activity and healthful eating as strategies for weight loss for patients with pre-diabetes.

Participants with pre-diabetes who participated in a 90-minute diabetes prevention class were consented to participate in this behavioral study and were then randomly assigned to receive automated telephone support targeting physical activity and nutrition weight loss strategies or to a no-contact control group. Objective physical activity (accelerometer), self-reported dietary intake, and body weight were assessed at baseline and at 3-months follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male and female Kaiser-Permanente of Colorado members age 18 and above who have been diagnosed with pre-diabetes and who have enrolled in a clinically indicated pre-diabetes class.
* Subjects must be English speaking and have a telephone

Exclusion Criteria:

Pregnant females

* Enrollment in another research study involving diabetes or weight management during the time of the study.