cyrilzakka/clinical-trials huggingface dataset:
RCT Mesenchymal Stem Cells Versus Hyaluronic Acid in OA Knee):

The purpose of this study is to evaluate the therapeutic effect of adult autologous mesenchymal stem cells (abbreviated as MSCs) in patients with osteoarthritic knee and compare to intra articular injection of Synvisc-One.

Study Participants:

This study will involve patients affected by osteoarthritis who comply with the inclusion and exclusion criteria. 30 patients, between the age of 18 and \<65, will be enrolled in the study and randomized into three groups to receive either an injection of MSCs, hyaluronic acid (HA) or no injection.

Type of Study: This is a randomized control study.

Treatment method: Each patient will randomly be assigned to one of the following treatment groups:

Group A) Mesenchymal stem cells (MSCs) Group B) Hyaluronic acid (HA) Group C) No injection

Treatment:

Group A) Autologous Mesenchymal Stem Cells Treatment (MSCs) The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.

The treatment will be carried out after the patient has received a blood test and clinically evaluated at T0.

T0: Beginning of the study, blood test and bone marrow aspiration. T30: Intra-articular injection of MSCs T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)

Group B) Hyaluronic acid (HA) The patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.) The hyaluronic acid will be purchased for the patient from the manufacturer or from the pharmacy of the hospital.

The intra-articular injection will be carried out after the patient has received a clinical evaluation at T0.

T0: Beginning of the study T30: Intra-articular injection of Synvisc-One (HA) T44: Adverse events follow up 2 weeks after intra-articular injection (by phone)

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged between 18 and \< 65
* Radiological evidence of osteoarthritis with Kellgren and Lawrence grade 2 and 3
* Patients on a pain level equal to or higher than 5 on a VAS scale of 10

Exclusion Criteria:

* Previous cases of alcoholism or drug abuse
* Pregnancy and breast-feeding
* Serious pathologies such as carcinoma or autoimmune disease
* Hypersensitivity toward Hyaluorinc Acid
* Undergoing steroid-based systemic therapy or interrupted since less than 1 month
* Significant hematologic diseases
* Mechanical instability, ligamentous laxity/deficiency or gross deformity
The Effect of Ketamine on Production of Inflammatory Markers in Post Operative Patients in Mulago Hospital

. Null Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will not have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.

. Alternate Hypothesis: Giving low doze ketamine (0.5mg/kg) given preoperatively to adult patients undergoing elective surgery, in Mulago hospital, will have a reduction effect on the levels of IL-6 \& IL-1β pro inflammatory markers by 48 hours.

RESEARCH QUESTION Can 0.5mg/kg of Ketamine given preoperatively have an effect on the levels of pro-inflammatory markers?

Primary specific Outcome: changes/deviations from baseline levels of IL- 6 pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.

Secondary specific Outcome: changes/deviations from baseline levels of IL-1β pro-inflammatory markers of after surgery at PACU, 24 and 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* Consented patients due for elective surgery
* Adult patients 18- 70 year old
* ASA I- ASA II scoring patients, who are normal patients or those with mild systemic illness

Exclusion Criteria:

* Emergency cases that will already have high levels of inflammatory markers secreted in their system by incision time e.g. road traffic accidents
* Patients with chronic / severe hypertension
* Febrile Patients (T \>38°C)
* Persistently raised blood pressures above 140/90 for 2 consistent readings 15 minutes apart
* Patients with pheochromocytoma
* Spinal and local infiltration anaesthesia cases
* Neuro surgery patients whom Ketamine is contra indicated
* Epilepsy patients
* ASA IIIE and above
* Patients receiving Aspirin prophylaxis
* Chronic inflammatory disease states such as hyperparathyroidism
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.

randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index range 19-30kg/m2
* Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
* STB from 2 to 10X ULN;
* ALP\>1.5X ULN or GGT\>3X ULN

Exclusion Criteria: any one of below,

* active virus hepatitis, or anti-HIV(+)
* exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA\>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
* other non-hepatic diseases caused jaundice
* primary hepatic carcinoma
Predictive Factors of Mortality in Invasive Fungal Disease in Post-surgical Critical Care Unit

Invasive fungal disease in the critically ill patient is a serious complication that increases hospitalization times, morbidity and mortality, and healthcare costs.

Our team proposes a retrospective observational study of patients from the resuscitation unit of the Hospital la Fe who during the years 2016-2019 presented invasive candidiasis. The investigators intend to detect if there are possible specific risk factors that favor the development of invasive candidiasis in colonized patients and if these associated risk factors could be considered as 'triggers' or alerts for the implementation of specific care in these patients.

To do this, the investigators intend to study the blood samples taken from patients, taking into account different types of perioperative variables from them, which will be statistically analyzed, so that evidence-based inferences can be drawn to demonstrate our hypothesis.

The hypothesis is that there are factors predisposing to the development of invasive fungal disease, invasive candidiasis, and that the detection of these factors may allow detecting the population at risk and implementing both pharmacological measures and general strategies to reduce the mortality of fungal infection.

Primary objective: To determine if candida auris is associated with increased risk of mortality in invasive fungal disease and the risk factors for mortality in the invasive fungal disease, including the species of candida that causes this disease.

Secondary objectives:

Determination of predictors of mortality in invasive fungal disease. Prepare and validate a score in our environment that allows discriminating those patients with a high risk of mortality.

To analyze the pharmacological management that has been carried out in patients who develop candidemia due to auris.

Detect hospital stays of both population groups, in terms of health management.

Type of study: observational, longitudinal, and retrospective study of cases and controls of a selected exposed population that developed the disease over time or not.

Eligibility Criteria:
Inclusion Criteria:

* More than 18 years
* Admitted to the ICU that present fungal invasive disease
Modulation of Adjuvant 5-FU by Folinic Acid and Interferon-alpha in Colon Cancer

The primary objective was to improve adjuvant 5-FU chemoradiotherapy in resectable rectal cancer. The investigators hypothesis was that modulation of 5-FU by addition of either FA or INF-alpha may increase overall survival.

Primary endpoint was overall survival (OS). For sample size estimation the following assumptions were made: The 5-year OS rate of 5-FU was estimated to be 58%. Our intention was to detect an increase in the 5-year OS rate by one of the additives of at least 10% with a power of 80% and a level of significance of 5% in comparison to 5-FU (one-sided). Hypotheses were analyzed as pair wise comparisons between the treatment options. This resulted in a target sample size of 280 patients per group and a total of 840 patients.

Eligibility Criteria:
Inclusion Criteria:

* Eligibility was defined as potentially curative en-bloc resection (R0) of an adenocarcinoma of the rectum with a lower tumor edge within 12 cm from the anal verge determined by rectoscopy, a pathologic UICC stage II (pT3/4pN0M0) or III (pT1-4pNposM0) with examination of at least 12 lymph nodes, a white blood count ≥ 3,500/µl, a platelet count ≥ 100,000/µl, a ECOG performance status of 0 or 1, and written informed consent.

Exclusion Criteria:

* Ineligible were patients not fulfilling these criteria or having a history of cancer except for adequately treated superficial basal or squamous cell skin cancer or in situ carcinoma of the cervix, getting previous radio- or chemotherapy, pregnant or nursing women, other having severe concomitant diseases limiting life expectancy or not allowing chemotherapy, and with social conditions not allowing a 5-year follow-up.
Cefepime-taniborbactam Vs Meropenem in Adults with VABP or Ventilated HABP

This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥18 years of age.
* The patient or patient's legally authorized/acceptable representative (LAR) has voluntarily signed and dated the IRB/IEC approved ICF
* Meets the clinical diagnosis of ventilated HABP or VABP
* Have at least one of the following clinical criteria:

  1. New onset or worsening of pulmonary symptoms and signs
  2. New onset or worsening of purulent respiratory secretions
  3. Hypoxemia
  4. Need for acute changes in ventilator support
* Have at least one of the following clinical criteria:

  1. Documented fever (defined as body temperature ≥ 38°C \[100.4°F\]
  2. Hypothermia (defined as body temperature ≤ 35°C \[95°F\])
  3. White blood cell (WBC) ≥10,000 cells/mm3 or ≤4,500 cells/mm3
  4. \>15% immature neutrophils (bands).
* Have new or worsening infiltrate on a pulmonary imaging study that is consistent with bacterial pneumonia within 48 hours prior to randomization.
* Have a lower respiratory tract specimen sent for Gram stain and quantitative culture within 36 hours prior to the first dose of study drug.

Exclusion Criteria:

* Receipt of effective antibacterial treatment for pneumonia for a continuous duration of \>24 hours during the previous 72 hours prior to randomization.
* Pneumonia known or suspected to be caused by:

  1. A bacterial pathogen resistant to meropenem, as assessed by susceptibility testing or against which either one or both study drugs lack activity
  2. Viruses, atypical bacteria, or fungi
* Use of non-study systemic gram-negative therapy.
* Confounding respiratory conditions.
* Receiving extracorporeal membrane oxygenation (ECMO).
* Patients with refractory septic shock.
* Active immunosuppression.
* Has a history of serious hypersensitivity (e.g., anaphylaxis), serious allergy, or any serious reaction to cephalosporin, penicillin, carbapenem, or other β-lactam antibiotics.
* Female patients who are pregnant.
* Patients with eGFR \<10 mL/min/1.73 m2 or are receiving or starting renal replacement therapy or expected to require renal replacement therapy during the treatment phase of the study.
Evaluation of Dorsal Visual Stream in Patients With Schizophrenia

Schizophrenia patients in comparing to normal controls show decreased ability to identify objects with decreased level of fragmentation, a task that is associated with magnocellular pathway function.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia

Exclusion Criteria:

* Ophthalomological or Neurological problems
* Left handed
Screening For First Trimester's Hyperglycemia in High and Low Risk Pregnancy

Glucose intolerance is the commonest medical disorder complicating pregnancy. Hyperglycemia increases the risk of delivering a large for gestational age newborn (LGA) and related complications such as operative delivery, birth trauma and the poor adaptation of the newborn . Maternal risks of GDM include also polyhydramnios, preeclampsia, premature delivery, prolonged labor, uterine atony, postpartum hemorrhage, infection and progression of retinopathy which are the leading global causes of maternal morbidity and mortality .Detection of women at higher risk for GDM early in pregnancy is a desirable goal because interventions such as diet, medication, and exercise may be applied earlier in pregnancy and potentially can reduce later development of GDM or its associated morbidities. Most GDM cases are diagnosed after mid-gestation following an abnormal glucose challenge test (GCT). However, about 10% of patients with GDM can be diagnosed in the first trimester.


Eligibility Criteria:
Inclusion Criteria:

* • History of gestational diabetes in previous pregnancies

  * Polycystic ovaries syndrome
  * History of Macrosomic baby in previous pregnancies
  * Past history of late third trimester fetal demise
  * Past history of polyhydramnios
  * Overweight /Obese women Women diagnosed to have other endocrinopathies like suprarenal, thyroid or pituitary disorders Multi fetal pregnancies Past history of shoulder dystocia Past history of preeclampsia Family history of diabetes

In addition, a comparable group of low-risk women will be included like primigravida healthy women or those with normal obstetric history.

Exclusion Criteria:

* all patient not have thev inclusion criteria
Cochlear Implant PDA Based Research Platform

The primary purpose of the research is to study how individuals who wear cochlear implants process sounds in noisy environments and also whether newly designed programs can help improve the communicative ability of cochlear implant patients in noisy situations.

Cochlear implants have been successful in restoring partial hearing to profoundly deaf people. Despite their success, most implant patients are not able to communicate in noisy environments (e.g., in a restaurant). Communicating in noise still remains one of the biggest challenges in cochlear implants. Little is known about the factors that contribute to the poor performance of CI users in noise. In this project, we propose a series of experiments aimed at isolating these factors. We propose new programs that can be tailored for noisy situations.

Eligibility Criteria:
Inclusion Criteria:

1. Post-lingually deafened adults:

   * 18 years of age or older
   * Unilateral or bilateral Nucleus implant users (this includes all three generations of the Nucleus system, i.e., CI22, CI24 and CI24R).
   * With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
   * A minimum test score of 30% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
   * Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
   * Minimum number of active electrodes: 10
   * Minimum number of subjects for each test site: 5
2. Prelingually and perilingually deafened adults:

   * 18 years of age or older
   * Unilateral or bilateral Nucleus implant users.
   * With or without residual hearing in the contralateral ear. Subjects may use amplification (hearing aid) in the opposite or same ear as the implant.
   * A minimum test score of 10% in tape-recorded open-set sentence recognition scores (e.g., spondee identification).
   * Minimum of 6 months experience with their implant device. This is done to ensure that all patients are familiar with the hearing sensations perceived by a cochlear implant.
   * Minimum number of active electrodes: 10
   * Minimum number of subjects for each test site: 5

Exclusion Criteria:

* Non-English speaking
* Hearing loss of neural or central origin
* Absence of cochlear or VIII nerve development
* The presence of systemic condition which would preclude use of a cochlear implant
* Active middle ear infection/tympanic membrane perforation
* Significantly abnormal cognitive function, as determined by case history information and/or clinical observations
* Significant psychiatric disorder, as determined by case history information and/or clinical observations
Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section

Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding efficacy in CS

The transversus abdominis plane block (TAPB) is administered between the internal oblique muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported that TAPB is an efficient analgesic approach following cesarean section .

The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is categorized into four types according to drug administration location, I (lateral), II (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can effectively decrease both visceral and somatic pain by LA distribution to the thoracic paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1 dermatomes. QLB is one of the regional techniques that provides the greatest benefit in post-CS pain control, as it is progressively applied in obstetric anesthetic precise to improve analgesic results.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status II
* aged 18 to 40 years old
* presenting for elective Cesarean section

Exclusion Criteria:

* body mass index (BMI) ≥40 kg/m2
* weight \< 50kg
* height \< 150 cm
* contraindications for the use of active labor, spinal anesthesia
* recent opiate intake
* hypersensitivity to any used medication
* substantial cardiovascular diseases
* renal diseases
* hepatic, diseases.
Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction

Malignant duodenal obstruction in patients not fit for surgery is treated by placing enteral stents during endoscopy. These patients may also have poor gastric motility. Hence bridging the pyloric opening with the stent along with the duodenal obstruction may deliver better symptomatic improvement. Both approaches are commonly clinically practiced but no formal comparative studies have been done to compare which one is better.

Enteral self-expanding metal stents are routinely used to palliate malignant gastric outlet obstruction (pancreas cancer, duodenal cancer, gastric cancer and metastasis) in patients not fit for surgical bypass. The technical success in placing these stents approaches \~100% and many of these procedures can be performed in an outpatient setting. However the functional success (patient's ability to eat) is much lower than the technical success. One of the major reasons for this discrepancy is these patients are on narcotics, which are known to be associated with poor gastric motility. At the discretion of the gastroenterologist, FDA approved enteral stents are placed either completely within the duodenum bridging the obstruction or placed across the pyloric opening besides bridging the duodenal obstruction. The significance of this study is to determine if trans-pyloric extension of an intra-duodenal stent facilitates better gastric emptying compared to an intra-duodenal stent without trans-pyloric extension.

Eligibility Criteria:
Inclusion Criteria:

1 - Confirmed diagnosis of cancer

2. Evidence of a single small bowel obstruction

3. Considered palliative (can be on narcotics, chemotherapy, and/or radiation therapy)

4. Not a surgical candidate

5. \>18 years of age

6. Able to give consent

7. Eligible for endoscopy (medically fit)

8. Able to traverse past obstruction with a guidewire

Exclusion Criteria:

1 - \<18 years of age

2. Unable to give consent

3. Pregnant

4. Have evidence of multiple sites of obstruction in the small bowel

5. Have evidence of duodenal obstruction secondary to gastric cancer

6. Ineligible for endoscopy (due to comorbidities or acuity of illness)

7. Unable to traverse past obstruction with a guidewire
Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis

The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( WON).


Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 yo) patients
* With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
* Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection

Exclusion Criteria:

* Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
* Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
* Uncorrectable coagulopathy.
Autosomal Dominant Polycystic Kidney Disease Somatic Mutation Biorepository

This study will analyze the germline and somatic mutations underlying the development of ADPKD in order to better understand the genetic mechanism responsible for the cystic transformation. Once identified, these mutations could help us understand better the mechanism leading to the development of this disease and may explain at least in part the phenotypic variability.

The presentation of ADPKD renal and extrarenal manifestations varies widely, even within families, and has been attributed to numerous genetic factors. One principal explanation came with the discovery that renal cyst lining cells from ADPKD patients undergo secondary somatic mutations, selective loss of the second copy of a respective normal polycystic kidney disease (PKD) gene. These somatic mutations can occur in either polycystic kidney disease 1 (PKD1) or polycystic kidney disease 2 (PKD2). Furthermore, various cysts in the same patient have been reported to harbor different somatic mutations. These findings implicated a cellular recessive mechanism for cyst formation in ADPKD, suggesting the possibility that the observed intra-familial variation in disease phenotype may, at least in part, be explained by variation in mutation type, the timing and number of somatic "second-hit" mutations in individual family members affected with the disease. However, there is currently very little known about the cellular genetic mechanism leading to cysts development and very few studies, addressing this issue.

Eligibility Criteria:
Inclusion Criteria:

* Males or females
* 18 years of age or older
* Confirmed diagnosis of ADPKD
* Undergoing a native nephrectomy
* Willing and able to provide informed consent

Exclusion Criteria:

* Unable or unwilling to provide informed consent