cyrilzakka/clinical-trials huggingface dataset:
Risk Factors Analysis for Clinical Important Postoperative Nausea and Vomiting

Postoperative nausea and vomiting (PONV) is a distressing and common complication after surgery. The concept of clinical important PONV (CI-PONV) assesses the impact of PONV on patient-reported outcomes. This research aims to conduct an analysis of the risk factors contributing to CI-PONV utilizing the least absolute shrinkage and selection operator (LASSO) and stepwise regression techniques. All 1154 patients participating in the FDP-PONV trial are included in this study and categorized into two groups: the CI-PONV group and the non-CI-PONV group. CI-PONV is defined as the occurrence of PONV with a simplified PONV impact scale score of 5 or higher within 24 hours after surgery. The LASSO method is employed to identify the most relevant variables from an initial set of 56 related variables and stepwise regression is used to further refine the selection of the ultimate predictors.A logistic regression model was developed based on the selected factors influencing CIPONV. A nomogram was developed as a tool for clinical application.

Drawing from prior studies, we conducted a sample size calculation for a predictive model using the website https://mvansmeden.shinyapps.io/BeyondEPV/. By setting the number of candidate predictors to 9, the events fraction to 0.14, and the criterion value for rMPSE to 0.04, we determined that a minimum total sample size of 900 is required, with a minimally expected event per variable of 13.9. All patients were classified into either the CI-PONV group or the non-CI-PONV group. All 56 perioperative clinical features, encompassing baseline characteristics, preoperative conditions, and intraoperative information, were considered as potential predictive factors. In the quest to uncover potential predictive factors associated with CI-PONV, we employed the least absolute shrinkage and selection operator (LASSO) to sift through clinically significant variables. Subsequently, we utilized stepwise regression based on the Akaike Information Criterion (AIC) to further refine the selection of the ultimate predictors. Finally, a logistic regression model was developed based on the selected factors influencing CIPONV. The discrimination of the model was assessed by the ROCAUC and the goodness of fit of the model was evaluated using the Hosmer-Lemeshow test and calibration plots. A nomogram based on the logistic regression model output was developed as a tool for clinical application.

Eligibility Criteria:
Inclusion Criteria:

a) age between 18 and 75 years, b) having 3 or 4 Apfel risk factors, and c) scheduled to undergo laparoscopic gastrointestinal surgical procedures under general anesthesia.

Exclusion Criteria:

a) American Society of Anesthesiologists (ASA) physical status greater than 3, b) severe hepatic dysfunction, c) contraindications to fosaprepitant, 5-HT3 receptor antagonist, or dexamethasone, d) preoperative use of medications known to have antiemetic properties, e) presence of mental disorders or inability to communicate, and f) pregnant or nursing women.
Fitness Trackers During and After Oncological Treatments

The overall goal of the present trial is to evaluate the patients' compliance for wearing a commercially available fitness tracker during and after oncological treatments.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed malignant disease
* Upcoming chemotherapy of radiochemotherapy
* Eastern Co-operative Oncology Group (ECOG) performance score 0-2

Exclusion Criteria:

* Pre-existing comorbidities that impair patient mobility.
* Eastern Co-operative Oncology Group (ECOG) performance score 3-4
Pregabalin for Opiate Withdrawal Syndrome

It is a single blind randomized symptom triggered study to assess efficacy and safety of pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs. clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.

Study design: Single-blind randomized symptom-regulated protocol with an active control. Eighty patients admitted to an inpatient addiction treatment program will be randomly assigned to two groups. The first group (N=40) receives up to 600 mg a day of Pregabalin for six days along with symptomatic therapy that is divided into basic treatment that is given to all patients (Doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the Opioid Withdrawal Scale and included Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine). The second group (N= 40) receives up to 600 micrograms of Clonidine a day as the main treatment along with the same basic and symptomatic regimen. Opiate withdrawal severity, craving, sleep disturbance, anxiety and depression, as well as general clinical impressions and side effects are assessed daily by psychiatrists who are blind to patients' group assignment using internationally validated quantitative psychometric instruments.

Eligibility Criteria:
Inclusion Criteria:

* Opioid Use Disorders; Opioid Withdrawal Syndrome

Exclusion Criteria:

* Severe psychiatric and somatic disorders, other Substance Use Disorders (except tobacco)
Intralesional Versus Intramuscular Hepatitis B Vaccine Immunotherapy for Warts

Assessment of the effectiveness of intralesional and intramuscular hepatitis B vaccine in treatment of multiple common warts.

Recently, intralesional immunotherapy by different antigens, including Candida antigen and purified protein derivative PPD has been proved effective in the treatment of different types of warts. Hepatitis B vaccine is one of the DNA vaccines that are regarded as being potentially safer, relatively cheap and easy to produce with no special storage requirements because they are extremely stable and allow for potential simultaneous immunization against multiple antigens or pathogens via co-expression of multiple epitopes on single plasmid. Hepatitis B vaccine could be a promising immunotherapeutic vaccine in the field of intralesional immunotherapy of warts. Moreover, the efficacy of intramuscular injection of hepatitis B vaccine would be assessed and compared to its intralesional injection.

Eligibility Criteria:
Inclusion Criteria:

• Adult patients of both sexes with multiple (\> 3 warts) common warts of various sites, sizes and duration, with or without distant warts after taking informed consent from all patients

Exclusion Criteria:

* Pregnancy or lactation.
* Serious systemic or anaphylactic reaction to a prior dose of the vaccine or to any of its components.
* Allergic skin disorders such as generalized eczema and urticaria.
* Moderate or severe acute illness with or without fever.
* Previous wart therapy within 1 month prior to the study.
Immunological Indices and Infections Among Pesticide Applicators in Sohag Governorate

The human body gets exposure to pesticides either directly or indirectly. By using pesticides on crops, humans come in direct contact with them and they affect the heaith

Immune system is the first defense line against pathogenic organisms; however, it is altered by the vulnerable environmental factors such as pesticides, which can cause structural or functional alterations in humoral or cell mechanisms (nonspecific or adaptive) of the immune response which lead to an increase in the susceptibility to infections


Eligibility Criteria:
Inclusion Criteria:

1. pesticide applicators
2. Age ;20-60 years
3. Exposure to pesticides for more than 3 months

Exclusion Criteria:

* Subjects have recent severe trauma or surgery or recent infections
A Study Investigating Formulations of Vortioxetine Applied Under the Tongue in Healthy Subjects

This study investigates formulations of vortioxetine applied under the tongue

Apart from the first two doses, the study design is flexible in terms of doses and pharmaceutical formulations and will be decided upon based on an evaluation of the safety and tolerability as well as plasma exposure obtained during the study.

* The study consists of 5 periods. Single-doses of vortioxetine will be administered in all periods.
* All subjects will receive the same pharmaceutical formulations of the same dose strength in the same period and sequence.
* In Period 1, each subject will receive an intravenous (IV) 10 mg dose of vortioxetine infused over 2 hours. The exposure obtained after IV administration will serve as the reference for the sublingually administered dosage forms.
* In Period 2, each subject will receive 5 mg of formulation A (SLA) of vortioxetine in a sublingual (SL) formulation with a holding time of 90 seconds. The holding time is the time where swallowing of saliva should be avoided.
* For the 3 remaining dosing periods, one or more of the following options in pharmaceutical formulation, dose, and dosing condition apply to this study:

  * Increases or decreases in dose (≤25mg) using same formulation
  * Change from formulation SLA to formulation SLB
  * Change in the holding time
  * Change to formulation SLC
  * Change in swallowing technique of the sublingual dosage forms

Eligibility Criteria:
Inclusion Criteria:

-The subject has a BMI ≥18.5 and ≤30.0 kg/m2 at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

-The subject is identified or confirmed to be a CYP2D6 poor metabolizer (PM)
Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

The purpose of this study is to determine if study drug (Pioglitazone) treatment will improve pre-diabetes (insulin resistance) or ealy diabetes and improve clinical symptoms (pain) or laboratory evidence of chronic pancreatitis.

The goal of the investigators is to gather information from this study to help gain understanding of a potential therapy for chronic pancreatitis.

The pancreas is a digestive organ that secretes insulin (and other hormones) into the blood for regulating blood sugar (glucose) and digestive enzymes into the intestine for digesting and absorbing nutrients consumed in meals. Chronic pancreatitis is a progressive clinical disease of the pancreas, associated with swelling (inflammation), scarring (fibrosis) and loss of normal functioning tissue. Patients develop diabetes mellitus (elevated blood sugar), malabsorption of nutrients, weight loss and pain. Presently chronic pancreatitis is considered an irreversible condition because the mechanisms responsible for chronic pancreatitis are poorly understood and no therapy is proven. However, recent studies provide important clues that oral medications (Thiazolidinediones) used to treat diabetes mellitus might improve or reverse features of chronic pancreatitis, including elevated sugar or diabetes, reduced secretion of digestive enzymes, and pancreatic swelling and scarring.

Note: Takeda Pharmaceuticals North America (TPNA) provided pioglitazone and placebo pills with identically appearance until June 28, 2010, approximately the middle of the study.

Eligibility Criteria:
Inclusion Criteria:

* Insulin resistance or mild diabetes mellitus
* Symptoms of abdominal pain
* Xray test showing damage to the pancreas
* Normal or mildly abnormal stool fat levels

Exclusion Criteria:

* Mentally disabled patients
* Women who are planning pregnancy, pregnant or lactating/nursing
* Chronic pancreatitis is due to other specific conditions

  * Autosomal dominant pancreatitis
  * Classic cystic fibrosis with lung involvement
  * Autoimmune pancreatitis
  * Pancreatic cancer
  * Biliary obstruction (non-pancreatic cause)
  * Abdominal trauma
  * Hypercalcemia
  * Hypertriglyceridemia
* Surgical resection of the head of the pancreas
* Alcohol consumption within prior 2 months
* Specific medical conditions

  * Gastric surgery
  * Celiac sprue
  * Crohns disease
  * Heart failure
  * Kidney failure
  * Cirrhosis or liver disease
  * Osteoporosis
  * Blood clotting disorder
  * Visual problems
  * Low albumin
  * Low BMI
* Specific medications \*Diabetes drug treatment is allowed except for short-acting insulin, long-acting insule more than 15 units daily, pioglitazone, rosiglitazone, orlistat, acarbose, miglitol or voglibose.
Antihypertensive Treatment in Masked Hypertension

The primary purpose of the study is to estimate the target organ protection after 12 months of antihypertensive treatment in masked hypertension patients with at least one kind of target organ damage (left ventricular hypertrophy, large arterial stiffness and microalbuminuria). Improvement was defined as the relevant parameter back to normal or declined at least 20%.

The secondary objectives include: blood pressure lowering effect, target organ damage parameters improvement, and the incidence rate of all cause death and cardiovascular events (stroke and myocardia infraction).


Eligibility Criteria:
Inclusion Criteria:

1. Age 30-70 years old
2. Masked hypertension patients, defined as clinic BP\<140/90 mmHg, while 24h ambulatory BP ≥130/80 mmHg and (or) daytime BP ≥135/85 mmHg and (or) nighttime BP ≥120/70 mmHg
3. Combined with at least one kind of target organ damage: left ventricular hypertrophy (Cornell voltage combination ≥2440mm·ms or Sokolow-Lyon index ≥4.0mv for male and 3.5mv for female), large arterial stiffness (brachial-ankle pulse wave velocity ≥1400cm/s) and microalbuminuria (twice random urine microalbuminuria/creatinine ratio ≥2.5mg/mmol for male and 3.5mg/mmol for female).
4. Didn't use any anti-hypertension drugs within 2 weeks
5. Be willing to participate in the trials and able to finish clinic visits

Exclusion Criteria:

1. Under antihypertensive treatment
2. Secondary hypertension
3. Taking other medications that may influence BP
4. Sleep apnea syndrome
5. Diabetes combined with microalbuminuria
6. Renal parenchymal disease, such as chronic nephritis, polycystic kidney
7. Occurrence of coronary heart disease, myocardial infraction or stroke within 6 months
8. Structural heart disease, such as hypertrophic cardiomyopathy, dilated cardiomyopathy
9. Alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBL) upper the twice of normal range, serum creatinine (Scr)≥2.0mg/dl, plasma hypokalemia≥5.5mmol/L,
10. Patients have contraindications to angiotensin receptor blockers (ARBs)
Study of the Effect of Transcranial Stimulations in Aphasic Subject Within a Year of Their Stroke

The aim of this work is to study the effect of transcranial direct current stimulation combined with naming therapy in acute and post-acute stroke comparing four bihemispheric positioning electrodes to a sham condition.

TDCS have shown a positive effect on clinical outcome in naming treatment in aphasic subjects however some aspects as the positioning of the electrodes on the head are still unclear. That is why we compare the effects of four different positionings of the electrodes (two anterior over Broca's area and its homologue and two posterior over Wernicke's area and its homologue) to a sham stimulation in order to observe if a more important effect of one or another positioning could be found.

Eligibility Criteria:
Inclusion Criteria:

* man or woman of 18 years and older
* aphasic patient following a first left hemispheric stroke
* BDAE 3.0 aphasia score \> or = to 1
* stroke within 3 to 12 months before inclusion in the study
* mother tongue = French
* right handedness
* signed informed consent

Exclusion Criteria:

* history of other neurologic pathologies
* epileptic seizure within 2 months before inclusion
* dementia
* bilingual patient (2 mother tongues)
* history of cranial surgery
* presence of intracerebral metallic material
* unauthorized molecules at inclusion : sulpiride, rivastigmine, dextromethorphan, carbamazepine, flunarizine, levodopa
* pregnant, parturient or lactating woman
Ridge Augmentation With Simultaneous Implant Placement Using Bone Blocks With Autogenous Tooth Graft

Autogenous bone, with its osteogenic, osteoinductive, and osteo-conductive characteristics has been used for bone grafts with optimal integration into host tissues. For this reason, autogenous bone has been often considered the gold standard of bone regeneration material. However, the amount of autogenous bone that may be harvested is limited, and the harvesting procedure is traumatic.

Bone substitutes, including allografts, xenografts, and alloplasts have been used successfully as alternatives to autogenous bone grafts in ridge augmentation procedures.

In 2008, autogenous tooth bone graft (ATG) was introduced and used for the first time as a bone grafting material for GBR. The tooth contents are extremely similar to that of the alveolar bone. The enamel inorganic, organic, and water contents are 95 percent, 0.6 percent, and 4 percent, respectively. However, in the dentin, the percentages are 70 to 75 percent, 20 percent, and 10 percent, respectively. They are 65 percent, 25 percent, and 10 percent, respectively, when compared to the alveolar bone content.

The aim of this study is to compare ridge augmentation using autogenous bone block (ABB) with immediate implant placement and filling the generated gap with autogenous bone graft (ABG) or ATG, or ridge augmentation using xenograft bone block (XBB) with immediate implant placement and filling the generated gap with ATG.


Eligibility Criteria:
Inclusion Criteria:

* Teeth with buccal bone destruction by periodontal disease and need extraction (horizontal or vertical bone defect);
* Absence of acute inflammation;
* Absence of uncontrolled systemic illness that would preclude implantation;
* Good dental and systemic healthy conditions;
* Patients were willing and able to return for multiple follow-up visits.

Exclusion Criteria:

* Patients with systemic illnesses,
* psychological abnormalities,
* para-functional habit,
* smokers or alcoholics,
* pregnant and lactating patients,
* patients undergoing or recently completed radiotherapy or chemotherapy,
* patients on drugs affecting the healing process,
* patients with endodontically treated teeth
L-Carnitine to Treat Fatigue in AIDS Patients

Patients with AIDS may develop a deficiency of the micronutrient carnitine and such a deficiency may contribute to fatigue in these patients. This study will determine whether carnitine supplementation will improve fatigue and related symptoms in carnitine-deficient patients with AIDS.

Fatigue is a commonly reported symptom in patients with end stage AIDS. Appropriate treatment can relieve suffering and improve quality of life. The role of progression of the disease, depression, anemia, and poor nutritional status in the development of fatigue is well recognized. However, the impact of micronutrient deficiencies has been minimally explored. AIDS patients are at risk for micronutrient deficiencies because of decreased caloric intake, increased metabolic requirements, and treatment with medications that can interfere with absorption, synthesis, and excretion. Patients with AIDS are particularly likely to be carnitine deficient.

Levocarnitine (L-carnitine) is a micronutrient found in meat and dairy products that plays a major role in energy metabolism. Preliminary research has shown that patients with end stage AIDS experienced decreased levels of fatigue after L-carnitine supplementation. This study will evaluate the effectiveness of L-carnitine to treat patients with carnitine deficiency, fatigue, and AIDS.

Participants in this study will be randomly assigned to receive either L-carnitine or placebo for 2 weeks. To reduce the possibility of side effects, the doses of L-carnitine and placebo will be titrated over 6 days to the desired study dose. After 2 weeks, participants receiving placebo will be switched over to receive L-carnitine. All participants will continue on L-carnitine for an additional 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* AIDS at Stage IV-C and estimated life expectancy \< 6 months
* Karnofsky Performance Score \> 50
* Clinically significant, persistent fatigue
* If undergoing pre-existing treatment for fatigue, must have been on a stable regimen for at least 4 weeks prior to study entry
* Concurrent use of epoetin alfa (PROCRIT®) will be allowed if the patient has been on a stable dose of epoetin alfa for at least 60 days prior to study entry

Exclusion Criteria:

* Severe cardiovascular, pulmonary, or renal function
* Hemodialysis
* Treatment or replacement therapy with any form of carnitine within 12 months prior to study entry
* Known sensitivity to carnitine
* Acute illness within 30 days of study entry that in the opinion of the study investigator would interfere with participation
* Active drug or alcohol use or dependence
* History of any central nervous system disease involving the brain that may put the patient at risk for seizure (e.g., primary or metastatic brain tumor, stroke) or history of seizure
* History of dementia, aphasia, or other deficits of cognition or speech/language function
Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease

The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own.

Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the diagnosis of Parkinson's disease, aged between 40 and 70, who provide verbal and written informed consent will be included. Patients should have access to a computer system for video calls and completing the questionnaires, and they must be able to use it.

Exclusion Criteria:

* Psychiatric symptoms such as moderate or severe depression
* Cranial metal implants
* Cardiac pacemaker
* Epilepsy, stroke
* Substance abuse
* Inability to adjust the neoprene cap with the electrodes independently due to movement disturbances