cyrilzakka/clinical-trials huggingface dataset:
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis

Ursodeoxycholic acid (UDCA) has been the only treatment for primary biliary cirrhosis (PBC) approved by US and European drug administrations. Long-term use of UDCA(13-15 mg/kg/day) in patients with PBC improves serum liver biochemistries and survival free of liver transplantation However, about 40% of patients do not respond to UDCA optimally as assessed by known criteria for biochemical response. Those patients represent the group in need for additional therapies, having increased risk of disease progression and decreased survival free of liver transplantation. Both lab research and some clinical studies suggest that fenofibrate could improve cholestasis in multiple ways including reduce of bile acid synthesis, increase of biliary secretion and anti-inflammation effect. Here we start a random, open and parallel clinical research to explore the effect of fenofibrate in the PBC treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Patient with PBC defined by 2 in 3 of the following criteria: a.Positive antimitochondrial antibody type M2; b.Abnormal serum alkaline phosphatases (ALP \> 1,5N) and aminotransferase (AST/ALT \> 1N) activities; c.Histological hepatic injuries consistent with PBC.

Exclusion Criteria:

1. Pregnancy or desire of pregnancy.
2. Breast-feeding.
3. Co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, Wilson's disease and hemochromatosis
4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).
5. History of urolithiasis, nephritis or renal failure (clearance of creatinine \< 60 ml/mn).
6. Hepatotoxic drugs use before recruiting.
7. Fenofibrate anaphylaxis.
Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria

Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. Infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa . The optimal treatment of such infections is not known. Antibiotics like polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics. The outcome of using these new and old drugs is not well studied. This observational study aims to study the clinical and microbiological outcomes of these infections and treatment at our institution.

Objectives

1. To define the demographic and risk factor profile of patients acquiring CRGNB infection.
2. To define the characteristics of CRGNB infection.
3. To report the different treatments employed for CRGNB infection.
4. To report the microbiological and clinical outcomes of different treatment options

   * a. Microbiological outcomes: frequency of microbiological success. Microbiological success will be defined as two successive negative cultures from the same site as from where the CRGNB was originally isolated.
   * b. Clinical outcomes: clinical success (clinical cure), adverse effects of treatment especially the nephrotoxicity in relation to the use of polymyxin, ICU length of stay (if applicable), hospital length of stay, ICU mortality (if applicable), hospital mortality and in-hospital recurrence of infection. Clinical success will be defined as resolution or improvement of clinical symptoms and signs of infection and discontinuation of the antibiotics.

Study duration:

We plan to collect the data for a one year period. Based on the current prevalence rate at our institution, we anticipate having data for 300 patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult in-patients (age≥18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa only). CRGNB Infection will be defined as isolation of CRGNB from any source requiring treatment with anti-infective agents with or without manifestations of systemic inflammatory response syndrome.

Exclusion Criteria:

* Patients colonized with CRGNB and not having an active infection.
* Recurrent infection in a previously included patient.
Pilot Randomized-controlled Trial of Integrated Palliative and Nephrology Care Versus Usual Nephrology Care.

The objective of this application is to conduct a pilot study testing the impact of integrated nephrology and palliative care versus standard nephrology care on patient-reported outcomes. This study is a preliminary study designed to determine feasibility of a palliative care study inclusive of kidney disease patients and to look for trends in impact over a 12-week follow-up period. Measurements will be taken at time one (time of enrollment) and time two (12 weeks). Our central hypothesis is that integration of palliative care with standard nephrology care in the ambulatory care of patients with a glomerular filtration rate (eGFR) ≤15ml/min/1.73m2 will trend towards improved symptom control, quality of life, and increased documentation of advance care planning when compared to usual nephrology care. We expect 10-15 patients per arm.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Age ≥18
2. Fluent English speaker
3. eGFR≤15 mL/min/1.73m2 (diagnosis of CKD stage V)
4. Able to give consent
5. Must be followed by a faculty group practice nephrologist

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Diagnosis of dementia
2. Non-English speaker
3. Have been seen by a palliative care provider prior to study entry
4. Pregnant women
5. On dialysis or have received a kidney transplant
Asymmetry of the Center of Pressure During Gait After Amputation of Lower Limbs

Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies.

Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes.

The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.


Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral lower limb amputees, walking with or without technical aids, hospitalized in the Locomotor Rehabilitation Department
* Adult patient (≥18 years) and less than 90 years of age.

Exclusion Criteria:

* Patients not autonomous for walking requiring a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population.
* Patients who objected to the use of their data.
Social Cognition Training in Individuals With Huntington's Disease

Individuals with Huntington's Disease have impaired social cognition, which is the domain of cognition that allows individuals to understand others' perspectives so that they can navigate interpersonal actions successfully (e.g., understanding someone may be sad based of their facial emotion or tone of voice and then responding in a sympathetic manner). Impaired social cognition is associated with impaired social functioning, poor psychological wellbeing and increased caregiver burden, which is known to be significant among those who care for individuals with Huntington's Disease. Computerized social cognition training has been shown to improve social cognition in individuals with schizophrenia, who, like individuals with Huntington's disease, have cognitive impairments. The investigators propose a pilot study of computerized social cognition training in individuals with Huntington's disease. This will be a feasibility study that aims to show that social cognition training in HD can be studied in preparation for a larger randomized controlled trial. The investigators hypothesize that social cognition training can improve social cognition, social functioning, and quality of life in individuals with Huntington's Disease and decrease caregiver burden among those who care for individuals with Huntington's Disease.


Eligibility Criteria:
Inclusion Criteria for Individual with Huntington's Disease

* Diagnosed with Huntington's Disease based on genetic testing
* Must be between 18 and 65 years of age
* Native English speaker who is literate in English
* Stable psychotropic medication regimen for 4 weeks
* Must have a score of "somewhat easily" on all items in the CPQ-12
* MOCA \>18
* Completed 12 years of schooling
* Access to laptop or mobile device
* Willingness to come in person 6-12 weeks after first visit

Inclusion Criteria for Caregiver of Individual with Huntington's Disease

* Lives with patient
* Must be between 18 and 65 years of age
* Native English speaker who is literate in English
* MOCA \>26
* Willingness to come in person within 6-12 weeks after first visit

Exclusion Criteria for Individual with Huntington's Disease

* Any known neurological condition (other than Huntington's Disease).
* History of learning and/or intellectual disabilities
* Currently actively involved in any other interventional trial (i.e. have begun the intervention) or within 4 weeks of completing the final assessments of an interventional trial.
* Currently regularly completing a computerized cognitive training intervention.
* Active suicidal ideation with some intent

Exclusion Criteria for Caregiver of Individual with Huntington's Disease

* Inability to provide informed consent
* Active suicidal ideation with some intent
A Retrospective Study of Toxicity and Outcome of High Dose Chemotherapy With Autologous Stem Cell Transplant in Patients With Hodgkin Lymphoma (HL).

The majority of patients with Hodgkin Lymphoma (HL)are cured with radiation therapy and/or combination chemotherapy. However, patients who relapse after attaining a complete remission with chemotherapy and those with primary refractory disease have a poor outcome with conventional chemotherapy regimens. Treatment results with standard-dose second-line regimens produce low complete remission rates and minimal survival benefit. Single institution studies have shown better outcome after autologous stem cell transplant in this group of patients when compared to historical controls receiving conventional treatment. In this retrospective review, we aim to analyze outcome and determine independent prognostic factors which would correlate with the long-term outcome of patients with HL who received an autologous stem cell transplant in the past at the Royal Marsden Hospital Eligible patients (those on current-follow-up) identified from the transplant database will be eligible for the study.

Accrual of eligible patients currently under follow-up will be performed in clinic at the time of next appointment. All patients accrued will give informed consent to participate in the study for retrospective case note review, after discussion with a study investigator and after receiving a study information sheet. The results of the analysis will be published in a peer-reviewed medical journal.


Eligibility Criteria:
Inclusion Criteria:

* a) Age over 18 b) Patients with Hodgkin Lymphoma who have received an autologous stem cell transplant c) Informed written consent

Exclusion Criteria:

* a) Medical or psychiatric conditions that compromise the patient's ability to give informed consent b) HIV positive or AIDS related lymphoma
Adjuvant Chemotherapy Plus Codonopsis Pilosula Nnannf /Placebo

Pancreatic carcinoma patients got benefit from adjuvant therapy after radical surgery. Gemcitabine combined with albumin-paclitaxel was recommended as the first-line regimen for adjuvant chemotherapy by NCCN guidelines. The most common non-hematological adverse events associated with gemcitabine combined with albumin-paclitaxel treatment were fatigue (54%), followed by alopecia (50%), and grade 3 or higher adverse events were mainly granulocytopenia, leukopenia, fatigue, and peripheral nerve damage. Cancer-related fatigue (CRF) is the most common concomitant symptom in cancer patients, especially during chemotherapy, which has a negative impact on patients' work, social relationships, emotions and daily activities. Therefore, it is of great clinical significance to improve CRF in cancer patients. From the perspective of traditional Chinese medicine, CRF patients will have a series of syndromes such as low function of viscera, general weakness, and emaciation, which last for more than 2 weeks and affect patients' physiology and psychology at the same time. Codonopsis pilosula Nnannf can restore the postoperative immune ability of patients as soon as possible after chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic adenocarcinoma was confirmed by pathology after radical resection.
* Patients received adjuvant chemotherapy after surgery, and the chemotherapy regimen was gemcitabine combined with albumin paclitaxel.
* ECOG score was less than 2.
* The expected survival time was more than 3 months.

Exclusion Criteria:

* Patients were received radiotherapy, chemotherapy within 4 weeks.
* Pregnant and lactating women.
* Patients were known to be allergic to the regimen.
A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver

This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
* Patient must have measurable disease
* Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
* Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
* Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.

Exclusion Criteria:

* Patients who have had prior therapy with Pemetrexed.
* Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
* Patients who have received radiation to more than 25% of marrow
Prevalence of Creatinine Phosphokinase Increase in Patients With Solid Tumors Treated by Inhibitors of Tyrosine Kinases

This study describes the elevation of CPK in patient treated for solid tumors by TKI


Eligibility Criteria:
Inclusion Criteria:

* Patients with solid tumor treated by inhibitor of tyrosin kinase for at least 1 week
* Patient examined AND with a routine blood test planned
* Patient informed of procedure for the study who was not opposed to it

Exclusion Criteria:

* Patient treated for malignant hemopathy
* Patient no treated by inhibitor of thyrosine kinase or for less than 1 week
* Patients with no routine blood laboratory tests planned
Abdominal Transcutaneous Electrical Acupoint Stimulation on Children With Autism Spectrum Disorder

The goal of this clinical trial is to learn if abdominal transcutaneous electrical acupoint stimulation (abdominal TEAS) works to treat autism spectrum disorder (ASD) in children. It will also learn about the safety of abdominal TEAS. The main questions it aims to answer are:

Does abdominal TEAS a safe and effective treatment for children with autism spectrum disorder and gastrointestinal symptoms? Researchers will compare abdominal TEAS to a placebo (a sham abdominal TEAS without stimulation) to see if abdominal TEAS works to treat ASD.

Participants will:

Take abdominal TEAS or sham abdominal TEAS 5 days a week for 8 weeks. Visit the clinic once every 4 weeks for checkups and tests Keep a diary of their symptoms.

Following randomization, participants had an appointment with the TEAS operator. The TEAS operators had a minimum of 2 years of experience in acupuncture treatment and held a membership with a national professional association in China. The Zhongwan (RN 12), bilateral Tianshu (ST 25), Qihai (RN 6) and Guanyuan (RN 4) acupuncture points were selected according to the concept of traditional Chinese medicine that specialized in treating gastrointestinal diseases, improving intestinal function, and eliminating various symptoms caused by intestinal dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed as autism based on the DSM-V and Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
* Aged 3 to 6 years

Exclusion Criteria:

* Diagnosed with other organic diseases (such as severe hearing and visual impairment, brain trauma) and neurological disease (e.g., epilepsy, Rett syndrome), or psychiatric disorder (schizophrenia, bipolar affective disorder, etc)
* Oral or injected antibiotics within 30 days before screening
* History of acupuncture, electroacupuncture, TEAS treatment before screening
* Taking antipsychotic drugs and psychobiotic supplements within 30 days before screening
The Role of Massage in Increasing Total Motile Sperm Count of IUI

The purpose of this prospective, randomized study, was to determine if neck and shoulder massage performed within 15 minutes of semen sample collection will increase the semen volume, and therefore increase the total motile sperm available for insemination as a result of decreased stress.


Eligibility Criteria:
Inclusion Criteria:

* Infertility,
* initiating clomiphene + IUI therapy
* signed study consent

Exclusion Criteria:

* Severe male infertility (baseline semen concentration \< 10 million total motile sperm)
* female bilateral tubal occlusion
* failure to ovulate with clomiphene
* failed clomiphene + IUI therapy (three prior cycles with no conception)
* unable to tolerate clomiphene
* unable or unwilling to follow study protocol
Silodosin vs Placebo in the Treatment of Female LUTS

This trial will be conducted to study the efficacy and safety of Silodosin in the treatment of female lower urinary tract symptoms.

The double blinded randomized controlled trial will evaluate efficacy and safety of silodosin in treatment of female lower urinary tract symptoms by comparing with placebo.

Eligibility Criteria:
Inclusion Criteria:

* Females complaining of lower urinary tract symptoms
* IPSS ≥ 8 or OAB - V8 score ≥ 8

Exclusion Criteria:

1. Patients with documented hypersensitivity to Silodosin.
2. Patients receiving alpha blockers or anticholinergic medications for any other reason.
3. Patients with history of orthostatic hypotension.
4. Pregnant or breastfeeding females.
5. Patients with stress urinary incontinence.
6. Patients with active urinary tract infection.
7. History of previous pelvic surgery or radiation.
8. Patient with diabetes mellitus.
9. Patients diagnosed with bladder cancer.
10. Patients with hepatic impairment (Child-Pugh score \>9).
11. Patients with severe renal impairment with creatinine clearance of less than 10 mL/min.
12. Patients planned to undergo any ophthalmic procedure.
13. Patients with history of urinary retention or gastric retention.
Pristinamycin in the Treatment of MSSA Bone and Joint Infection

Staphylococcus aureus represents the leading pathogen implicated in bone and joint infection (BJI), usually requiring prolonged combination antimicrobial therapy, which may be particularly challenging in the case of MDR bacteria and/or for patients with multiple drug intolerance. In the absence of new well-tolerated oral antistaphylococcal drugs, older antibiotics must be considered, such as the pristinamycin.

However, pristinamycin is not currently licensed for treatment of staphylococcal BJI and lack of clinical data prevents it from being considered as a reliable alternative therapeutic option in current guidelines.

The aim of this study is to evaluate pristinamycin (efficacy and tolerance) in the treatment of MSSA bone and joint infection (BJI).


Eligibility Criteria:
* Inclusion Criteria:
* All patients receiving pristinamycin as a part of treatment for an MSSA BJI and followed up between 2001 and 2011 in the infectious diseases department of Hospices Civils de Lyon (HCL)
* Exclusion Criteria:
* Patients with BJI related to diabetic foot or decubitus ulcer
Randomized Study of Human Parathyroid Hormone in Middle-Aged Men With Idiopathic Osteoporosis

OBJECTIVES:

I. Determine the effect of human parathyroid hormone (1-34) on bone mass in middle-aged men with idiopathic osteoporosis.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients self-administer daily subcutaneous injections of human parathyroid hormone (1-34) or placebo for a period of 2.5 years.

Patients are followed regularly for unacceptable toxicities.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Osteoporosis as defined by: Bone mineral density at the lumbar spine or femoral neck that is 2.5 standard deviations below peak bone mass reference value (T score less than -2.5)

No family history of male osteoporosis

No other metabolic bone disease

--Prior/Concurrent Therapy--

Endocrine therapy:

* No concurrent glucocorticoid therapy
* No prior steroid use

Surgery: No prior gastrointestinal tract surgery

Other: No prior or concurrent anticonvulsant therapy

--Patient Characteristics--

Hematopoietic: Normal CBC

Hepatic: Normal liver function

Renal: Normal renal function

Other:

* Normal thyroid function
* Normal adrenal function
* Normal gonadal status
* No myeloma or other malignancy
* No alcoholism, hypercortisolism or diabetes mellitus
* No gastrointestinal tract disease or disorder associated with malabsorption