cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Electrical Pudendal Nerve Stimulation for Neurogenic Lower Urinary Tract Dysfunction

The main goal to treat early NLUTS is to relieve lower urinary tract syndrome and prevent from late complications. The present study is to evaluate the efficacy of electrical pudendal nerve stimulation (EPNS) and transanal/transvaginal electrical stimulation (TES) in NLUTD.The study design consists of a non-randomized, parallel controlled trial. A total of 60 eligible patients will be involved and divided into EPNS or TES group according to their location of medical treatment. The primary endpoint is lower urinary tract syndromes (ICIQ-FLUTS/MLUTS). The second endpoint is assessment of daily life Qol (ICIQ-LUTSqol), and residual urine volume.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+ years;
* Diagnosed as NLUTD;
* Incomplete spinal cord injury (SCI), including but not limited to conus medullaris syndrome, cauda equina syndrome, etc.;
* Radical pelvic surgery: including but not limited to total hysterectomy etc.;
* Informed consent signed.

Exclusion Criteria:

* Anatomical bladder outlet obstruction (e.g., prostate enlargement, tumors);
* NLUTD induced by stroke, multiple sclerosis, HIV, diabetes mellitus, drug, and inflammation or tumor of central nervous system etc.;
* Lower urinary tract infections;
* Unwillingness to participate.
Study of Endothelial Cell Condition After Cataract Surgery Performed Using Capsulorhexis or ZEPTO

This study will use images of the subjects' corneal endothelium obtained using non-invasive specular microscopy to obtain corneal endothelial cell density, the coefficient of variation in endothelial cell size, and the percentage of hexagonal endothelial cells following routine cataract surgery performed using the standard method of manual capsulorhexis compared to cataract surgery performed using Zepto Precision Capsulotomy System.


Eligibility Criteria:
Inclusion Criteria:

* Subjects consenting to undergoing phacoemulsification and IOL implant surgery for the treatment of symptomatic age-related lens cataract, and then electing to undergo the study,
* Subjects must be willing and able to return for scheduled treatment and follow-up examinations at 1 and 3 months.

Exclusion Criteria:

* Pre-existing corneal endothelium pathology
* Presence of guttae
* Narrow angle glaucoma or advanced glaucoma
* Psuedoexfoliation
* Zonular abnormalities
* Corneal endothelial cell density less than 1800 cells/mm2
* Uveitis
* Anterior chamber depth less than 2.5mm or greater than 3.75mm
* Cataract grade LOCS II \> 3
* Posterior polar cataract
* Planned implantation of IOL \> 25D
* Prior ocular surgery in the study eye
* History of medications with potential corneal endothelial cell toxicity
* Any condition that in the surgeon's judgement should exclude the subject from study enrollment.
* Current participation in another drug or device clinical study, or participation in such a clinical study within the prior six months and during the duration of the current study
Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome

The primary objective of this study is to measure the prevalence of preoperative dehydration in elective major abdominal urologic surgery when we apply our daily standard operation procedures. Secondary objectives are to assess the impact of preoperative dehydration on postoperative outcome. The hypothesis is that preoperative dehydration leads to more postoperative complications.

The information about the impact of preoperative dehydration on postoperative outcome is conflicting. One of the reported difficulties of the studies in this field is to get adequate power for statistical significance. The incidence of preoperative dehydration in different surgical populations has been reported in about one third of patients. The prevalence in the urologic population is not known.

This is a monocentric observational study with no study intervention. The goal is to consecutively include all patients undergoing major urologic surgery during 365 days who meet the inclusion criteria to assess the prevalence of preoperative dehydration in elective major abdominal urologic surgery when the standard operation procedures of the University Hospital Bern are applied.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Major elective urologic surgery i. Prostate surgery ii. Bladder surgery iii. Kidney surgery iv. Various laparotomies / laparoscopies (e.g. retroperitoneal lymphadenectomy)
* Standard procedure planned
* Standard perioperative management planned
* Informed consent

Exclusion Criteria:

* Preoperative iv-fluids
* Pregnancy (which is a contraindication to this type of surgery per se)
* Inability to give informed consent (e.g. severe psychiatric disorder, dementia)
* Inability to complete the Quality of Recovery (QoR) questionnaire
* Enrolment of the investigator, his/her family members, employees and other dependent persons
Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients

The purpose of the study is to determine the safety, acceptability and the efficacy of a 12-week intervention with a diabetes-specific oral nutritional supplement on glycaemic control in type 2 diabetic patients with or at risk of malnutrition


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes according to the WHO diagnostic criteria for more than 6 months: Fasting plasma glucose (FPG) ≥ 126 mg/dl (7.0 mmol/l) or 2-h plasma glucose ≥ 200 mg/dl (11.1 mmol/l) during an OGTT (oral glucose tolerance test);
* HbA1c between 6.5-8.5 % (confirmed in the previous 3 months),
* capable of using oral nutritional supplementation,
* on stable and controlled anti-diabetic regime for at least 1 months,
* use of metformin and/or sulphonylureas as oral anti-diabetic medication,
* in need of nutritional support because of ≥5% involuntary weight loss in the last 3 months, ≥10% involuntary weight loss in the last 6 months, inadequate nutritional intake causing failure to meet nutritional requirements or at risk of developing malnutrition

Exclusion Criteria:

* diabetes type 1,
* participation in a clinical trial with an investigational product or regular use of disease-specific oral nutritional supplements within 4 weeks prior to study start
* patients requiring a fibre free diet,
* enteral tube feed or parenteral nutrition,
* concomitant therapy with systemic glucocorticoids, insulins or anti-diabetic medication other than metformin and sulphonylureas,
* known or suspected intolerance or allergy to any component of the investigational product(s),
* any acute gastrointestinal disease within 2 weeks prior to study entry,
* gastrectomy, gastroparesis or other gastric emptying abnormalities,
* acute sever heart failure (NYHA class 4), liver insufficiency / failure (male: ALAT \> 150 U/l; female: ALAT \> 120 U/l) or renal failure requiring dialysis,
* cancer cachexia,
* galactosaemia, fructosaemia,
* suspicion of drug abuse, abuse of/addiction to alcohol,
* pregnant or breast feeding women, or fertile women refusing to use contraceptives,
* patients with untreated major psychiatric disorder,
* known HIV positive (safety reasons),
* patient unable to co-operate adequately
Allogeneic Stem Cell Transplant With Clofarabine, Busulfan and Antithymocyte Globulin (ATG) for Adult Patients With High-risk Acute Myeloid Leukemia/Myelodysplastic Syndromes (AML/MDS) or Acute Lymphoblastic Leukemia (ALL)

Clofarabine is known to have a stronger anti-tumor effect than Fludarabine and has shown its efficacy in treating aggressive acute leukemias. In addition, evidence is that it is well-tolerated with manageable side effects especially in elderly patients. Thus, replacing Fludarabine with Clofarabine in a reduced intensity transplant regimen may provide a regimen with increased anti-tumor activity without adding significant risks of toxicity.The purpose of this study is to evaluate the efficacy and the safety of clofarabine in combination with IV busulfan and ATG as the backbone of a reduced intensity conditioning regimen for allogeneic stem cell transplantation for the treatment of patients with high-risk MDS/AML or ALL not eligible to conventional or standard myeloablative allo-SCT.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* For patients younger than 50 years, cons-indication for the use of a standard myeloablative conditioning (history of hematopoietic stem cell transplantation autologous or allogeneic, or the presence of co-morbidities or medical history making prohibitive in terms toxicity using chemotherapy and / or high dose radiotherapy as judged by the referring physician) - MDS, ALL or AML at high risk, WHO THE biphenotypic-Score \<2
* Any primary diagnosis of high-risk MDS/AML or ALL eligible for a treatment by reduced intensity conditioning (RIC) allogeneic hematopoietic stem cell transplantation (allo-SCT)
* Suitable donor available (related or matched unrelated)
* Cardiac: LV Ejection Fraction ≥ 50% by MUGA or Echocardiogram.
* Pulmonary: FEV1 and FVC ≥ 50% predicted, and DLCO (corrected for hemoglobin) ≥ 50% of predicted
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%
* Informed consent signed by patient prior to enrolment

Exclusion Criteria:

* Age \<18
* Age \>65
* Known hypersensitivity to clofarabine or excipients- Other hematologic malignancies than ALL, AML and MDS
* Patients with prior standard allogeneic HSCT with grade \> 2 aGvHD
* Prior standard allogeneic transplantation if \< 2 months
* Contra-indication to one of the drug of the RIC regimen .
* Patient with \> 3 treatment lines prior to inclusion
* Pregnant or lactating females
* Patient HIV+, Hep B+, Hep C+- Uncontrolled systemic infection
* Performance Status Score ECOG \> 2- Known central nervous system involvement with AML or ALL- Uncontrolled active infection of any kind or bleeding
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen.
* For patients younger than 50 years, possibly indicating a standard myeloablative conditioning
Allergic Versus Non Allergic Hypersensitivity Drug Reaction (BdDAllergo)

The creation of a database containing the medical data of patients followed in allergology at the University Hospital of Grenoble will permit to study allergic versus non-allergic hypersensitivity drug reaction as well as the risk of cross-reactions between medicinal drugs belonging to the same pharmacological class.

The main objectives of the study are to estimate and to compare the proportion of allergic hypersensitivity drug reaction and the proportion of non allergic hypersensitivity drug reaction, and to characterize these two types of hypersensitivity drug reaction on clinical, biological and chronological aspects.

In a second time, ancillary study will be conducted in order to :

* identify drugs that potentially induced histamine-liberation in patients diagnosed with non allergic hypersensitivity drug reaction
* investigate the risk of cross-reactions between drugs belonging to the same pharmacotherapeutic class in patients diagnosed with allergic hypersensitivity drug reaction.

This study is an observational cohort study conducted at University Hospital of Grenoble. It include retrospectively and prospectively the patients followed in the allergology department for the realization of immunoallergological test after suspicion of hypersensitivity drug reaction. The data are collected in a database from medical consultation reports that are systematically reported to the pharmacovigilance regional center. An anonymization number is assigned for each patient included in the study.The data collected include patient's personal and family medical history, a clinical, biological and chronological description of the hypersensitivity reaction, the results of the immunoallergologic skin tests as well as the final diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Cases where a non-iatrogenic cause was finally identified

Exclusion Criteria:

* For the estimation and comparison of the proportions, the patients who haven't carried out all their immunoallergologic tests investigations at the University Hospital of Grenoble are not included (this concerns patient who have realized only oral rechallenge test at hospital)
* To realize the comparative analysis of allergic versus non-allergic hypersensitivity drug reaction : cases that are insufficiently documented on clinical, biological and / or chronological aspects are excluded. This concerns especially patients who realize immunoallergologic tests investigations after a skin reaction that occurred "in childhood".
Efficacy of Genicular Nerve Alcohol Neurolysis in Knee Osteoarthritis Pain

This study aimed to evaluate the efficacy of genicular nerve alcohol neurolysis in the treatment of pain caused by chronic knee osteoarthritis. The investigators will evaluate the efficacy of genicular nerve alcohol neurolysis using the numeric rating scale (NRS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). NRS and WOMAC scores will be evaluated before, 1, and 3 months after the procedure.

Alcohol neurolysis of the genicular nerve is a procedure that involves injecting alcohol around the nerve branches that supply sensation to the knee joint. The alcohol destroys the nerve fibers and blocks the transmission of pain signals from the knee to the brain. This technique can be used to treat chronic knee pain caused by osteoarthritis (OA).

Several studies have reported that alcohol neurolysis of the genicular nerve can provide significant pain relief and functional improvement in patients with knee OA or postoperative pain. For example, Dass et al. (1) reported two cases of alcohol neurolysis of the genicular nerve using fluoroscopy and ultrasonography in patients with knee OA or persistent postsurgical pain of the knee. Both patients had more than 50% reduction in their numerical rating scale (NRS) scores and improved range of motion and quality of life at 3 months follow-up.

Ultrasonography-guided genicular nerve alcohol neurolysis is prominent with its easy applicability and low cost. There are no studies in the literature evaluating the efficacy of genicular nerve alcohol neurolysis for chronic knee OA. In this prospective study, the investigators will evaluate the NRS and WOMAC scores of patients who underwent genicular nerve alcohol neurolysis for chronic knee OA before, 1, and 3 months after the procedure. In addition, the incidence of procedure-related adverse events (such as paresthesia) recorded in patient records will be analyzed.

1. Dass RM et al. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain 2019; 32 (3): 223-227. https://www.epain.org/journal/view.html?doi=10.3344/kjp.2019.32.3.223

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale)
* Permanent pain for more than 6 months
* Grade 3 or 4 in the radiological Kellgren-Lawrence classification having osteoarthritis
* Pain with conservative methods such as analgesics and physiotherapy treatment failure

Exclusion Criteria:

* History of intra-articular knee intervention in the last 6 months
* Cognitive impairment
* Hepatic or renal insufficiency
* Severe psychiatric illness
* Local or systemic infection
* Coagulopathy
Molecular Epidemiology of Rotavirus Diarrhea Among Infants and Young Children Attending Maua Methodist Hospital, Kenya

Rotavirus is the most common cause of severe infantile diarrhoea disease in infants and young children below five years worldwide. It is associated with high cases of morbidity and mortality and it is estimated that up to 600,000 deaths in young children occur annually in the less developed countries and approximately 150,000-200,000 deaths occur in Africa alone. In Kenya, most rotavirus surveillance work has been done in Nairobi (an urban setting). Other parts e.g eastern Kenya, limited data is available and hence the prevalence and burden of rotavirus disease is under-estimated. We therefore hypothesize that rotavirus prevalence is high in Meru,Maua (a rural setting)and hence we designed a study to evaluate this.

This is a prospective study to determine, the rotavirus disease burden and epidemiology in infants and children with severe diarrhoea hospitalized in three sentinel hospital in the eastern part of Kenya (Maua Methodist hospital) will be carried out during the period January 2009 to December 2010.

Faecal samples will be collected from infants and children admitted with acute diarrhoea and screened first for the presence of human serotype A rotavirus antigen using commercially available enzyme linked immunosorbent assay kit (ELISA).

The positive samples will be evaluated by sodium dodecyl polyacrylamide gel electrophoresis (SDS-PAGE) to determine the electropherotypes and genotyped using reverse transcriptase polymerase chain reaction (RT-PCR) on VP7 and VP4 gene.

These data/ results generated from this project will add crucial information on the rotavirus strains circulating in the eastern part of Kenya.


Eligibility Criteria:
Inclusion Criteria:

* Only children under 5 years of age who present with acute diarrhea having experienced an episode of 3 looser than normal or watery stools in a 24-hour period with or without episodes of vomiting will be enrolled in this study.
* And the diarrhea should last for ≤ 7 days.
* Clinical studies have indicated that the incubation period for rotavirus illness is less than 48hrs and usually will last for 5-7days (Steele, 1998) Based on this fact, and as per the WHO's Generic Protocol for Hospital based Surveillance of Rotavirus Gastroenteritis in children under 5 years of age (WHO Generic protocol, 2002)

Exclusion Criteria:

* Children more than 5 years of age and with diarrhea lasting \> 7 seven days and having bloody diarrhea will be excluded in the study.
* This is as per the who's generic protocol for hospital based surveillance of rotavirus gastroenteritis in children under 5 years of age (WHO Generic Protocol, 2002)
Topical Agent for Treatment of Red Skin

SR-01 may reduce facial redness. it is a topically applied product. The agent will be applied to local skin areas of subjects with red facial skin to assess affect, and then applied to the whole face to assess efficacy and safety


Eligibility Criteria:
Bilaterally symmetric red skin on cheeks Caucasian Age 18-60 years
Palliative Care in Spinal Muscular Atrophy (SMA) 1

The purpose of this study is to evaluate the quality of supportive and palliative care for SMA type 1 patients.

Spinal Muscular Atrophy Type I (SMA I) is the most severe form of SMA. It presents in infancy and death occurs by 2 years. There is actually no curative treatment for this pathology. Support and help must be provided from the time of presentation till death and usually this period is quite short, about a couple of months. Variations in medical practice have be seen, depending on the medical experience and sometimes coupled with differences in family resources and values. The aim of the study is to evaluate the needs of the patients and their families, the medical practices, and to describe a cohort of SMA type 1 patients with the natural history of this disease. For this, a follow-up diary will be done, and this diary will be completed by the families and the different practitioners working with the patient. Will be noted in it : physical signs, all therapeutic choices and actions, evaluation of the pain and treatments. A special part of this follow-up diary will be completed by the medical doctors, after the death of the patient, with all the medication used at time of death and the conditions of the death. One year after the death of the patient, a questionnaire will be proposed to the parents of the child by a psychologist. This questionnaire will estimate the benefice of the follow-up diary, and the improvements to give in the diagnostic strategies, recommendations for assessment and monitoring, and therapeutic interventions in SMA type 1.

Eligibility Criteria:
Inclusion Criteria:

* SMA type 1 under 1 an
* Genetic confirmation

Exclusion Criteria:

* No genetic confirmation
* SMA type 1 over 1 year
Cognitive Behavioral Therapy and the Nicotine Transdermal Patch for Cannabis Dependence and Nicotine Dependence

The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.

The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. Twelve subjects (50% female, ages 18-65) who meet Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for both marijuana and nicotine dependence and seek treatment to stop using both marijuana and tobacco will receive individual CBT aimed at treating both disorders, as well as Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch. Subjects will start with a 21-mg nicotine patch for 6 weeks, followed by a taper to a 14-mg nicotine patch for 2 weeks and, finally, a 7-mg nicotine patch for 2 weeks. Others will start with a 14-mg patch for 8 weeks followed by a 7-mg patch for 2 weeks. All participants will receive 10 weeks of 1-hour weekly CBT with an experienced clinician. Follow-up visits, scheduled at 4, 6, 8, and 10 weeks, will evaluate of the durability of treatment effects on drug use and psychosocial outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-65 years
* current DSM-IV cannabis dependence
* current DSM-IV nicotine dependence
* express a desire to quit cannabis and nicotine use within the next 30 days
* daily use of ≥ 10 tobacco cigarettes
* for women of childbearing age, a negative pregnancy test at screening with agreement to use adequate contraception to prevent pregnancy and additional pregnancy tests at weeks 4 and 8
* Expired breath carbon monoxide (CO) determination is greater than or equal to 7 ppm over ambient values

Exclusion Criteria:

* Current diagnosis of other drug or alcohol dependence (other than cannabis or nicotine)
* recent (within 3 months) significant cardiac disease
* current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder or significant current suicidal or homicidal thoughts
* current use of bupropion
* current NRT or other smoking cessation treatment
* current CBT or other behavioral treatments for cessation of marijuana or tobacco smoking
* current smokeless tobacco use
* inability to read or write in English