cyrilzakka/clinical-trials huggingface dataset:
Investigation of the Effect of N Acetylcysteine Against Anti-Tuberculosis Drugs Induced Liver Toxicity

Tuberculosis is one of the major health problems in developing countries. Isoniazid, rifampin and pyrazinamide, the first line drugs used for tuberculosis chemotherapy, are associated with hepatotoxicity. The rate of hepatotoxicity has been reported to be much higher in developing countries compared to that in advanced countries with a similar dose schedule. Oxidative stress has proposed as one of the mechanisms responsible for anti-tuberculosis drugs induced hepatic injury. The oxidative stress is closely associated with decrease of glutathione levels. In the present study N acetylcysteine, a precursor of glutathione, was investigated for hepatoprotective effect against anti-tuberculosis drugs induced liver injury.


Eligibility Criteria:
Inclusion Criteria:

* Two sputum specimens positives for tubercle bacilli on direct smear microscopy
* No previous anti-TB chemotherapy higher than two weeks
* Aged 60 years and over
* Agreement to participate in the study

Exclusion Criteria:

* Alcohol consumption
* Viral disease (Hepatitis,...)
* Abnormal pretreatment LFT level
* Chronic disease (liver and kidney disease, asthma,...)
* Additional hepatotoxic drug use
* HIV positive
* Liver TB
* Patient in a moribund state
* Hemoptysis
RCT Comparing KS Versus TS for Ovedenture

To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants


Eligibility Criteria:
Inclusion Criteria:

* Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
* 18 years or older, and able to sign an informed consent.
* Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day).
* In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.

Exclusion Criteria:

Exclusion criteria

* General contraindications to implant surgery.
* Patients irradiated in the head and neck area.
* Immunosuppressed or immunocompromised patients.
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients with untreated periodontitis.
* Patients with poor oral hygiene and motivation.
* Previous guided bone reconstruction at the intended implant sites.
* Uncontrolled diabetes.
* Pregnancy or nursing.
* Substance abuser.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for implant placement.
* Patients with infection and or inflammation in the area intended for implant placement.
* Patients participating in other studies, if the present protocol cannot be properly adhered to.
* Patients referred only for implant placement and cannot be followed ant the treating centre.
* Patients unable to be followed for 5 years.
The Role of Prophylactic Central Compartment Neck Dissection in the Management of 2 to 4 Cm Papillary Thyroid Carcinoma

This randomized prospective study aims to evaluate the advantages and disadvantages (both oncologic and surgical) of prophylactic central compartment neck dissection for clinically node-negative 2-4 cm papillary thyroid carcinoma patients who have been treated either with total thyroidectomy alone or with total thyroidectomy + prophylactic central compartment neck dissection .


Eligibility Criteria:
Inclusion Criteria:

1. PTC documented by fine needle aspiration cytology (FNAC) (TIR 4 or TIR 5 according to the Italian consensus for the classification and reporting of thyroid cytology \[15\]);
2. no pre-operative evidence of lymph node metastases (cN0) at palpation and neck ultrasound (US);
3. no clinical evidence of distant metastasis at diagnosis;
4. age ≥ 18 years.

Exclusion Criteria:

1. histotypes other than PTC;
2. evidence of lymph node metastases during surgery even if not previously diagnosed;
3. presence of distant metastasis.
A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)

This study examined the safety of the drug MK-6552 and if people tolerated it. It also studied whether MK-6552 works better than placebo for staying awake in sleep deprived healthy participants.


Eligibility Criteria:
Inclusion Criteria:

Criteria include but are not limited to the following:

* Is in good health
* Body Mass Index (BMI) between 18 and 32 kg/m\^2, inclusive.

Exclusion Criteria:

Criteria include but are not limited to the following:

* History of or current hypertension,
* Has a history of sleep disorders:
Human Umbilical Cord Blood Infusion in Patients with Cerebral Palsy

A phase I, randomized, double-blind, placebo-controlled clinical study to assess the safety and efficacy of allogeneic human umbilical cord blood infusion in children with cerebral palsy

This is a phase I study to evaluate the safety and efficacy in hUCB treatment on the patients with cerebral palsy (CP).

Eligibility Criteria:
Inclusion Criteria:

* Male or female underage at the time of screening.
* With a confirmed diagnosis of CP
* non-progressive motor disability
* brain dysfunction

Exclusion Criteria:

* Judged by the Investigator to be not suitable/eligible for study participation.
POC Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Active Intermediate, Posterior, or Pan NIU

This is a multi-center, randomized, double-masked, proof-of-concept study in patients with Active Noninfectious Intermediate, Posterior, or Panuveitis.

This study will consist of a 2-week screening period (+7 days), 24-week treatment period, followed by a 24-week extension period, and a 4-week follow up period for a total of up to 55 weeks. Each participant will be randomized to receive one of two doses of ESK-001 daily for 24 weeks. Participants that do not meet the treatment failure criteria at Week 24 will continue into the extension period.

Eligibility Criteria:
Key Inclusion Criteria:

* Able and willing to provide consent
* Male and females, age 18 to 70 years
* Diagnosis of active noninfectious intermediate, posterior or panuveitis
* Must have active uveitis at Screening in at least one eye as defined by:

  1. Active inflammatory chorioretinal and/or inflammatory retinal vascular lesion or lesions, or
  2. ≥ 2+ VH in accordance with the NEI/SUN criteria
* Males and females must use highly effective methods of contraception for the entirety of the study

Key Exclusion Criteria:

* Diagnosis of infectious uveitis
* Has elevated intraocular pressures or severe glaucoma
* Positive for HIV, Hepatitis B or C or active or inadequately latent tuberculosis at screening
* Positive for syphilis at screening
* Patients with QTcF \>450 msec (both males and females) at screening
* Known active malignancy or history of malignancy within the past 5 years
* History of chronic drug or alcohol abuse
* Live vaccines
* No planned ocular or any other surgery during the course of the study

Other protocol-defined inclusion/exclusion criteria apply.
Hepatic Xenetix-CT Perfusion

The purpose of this study is to prospectively determine the diagnostic value of Xenetix-CT perfusion for the discrimination between well-differentiated hepatocellular carcinomas (HCC) and poorly/moderately differentiated HCC, in histo-pathologically proven HCC, and with the aim to cover the entire liver.


Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed for HCC and planned for surgery (lobectomy or transplantation) within a timeframe of 30 days between first imaging procedure used for the study and surgery.

Exclusion Criteria:

* Subjects who have undergone prior TACE (TransArterial Chemo Embolization), prior RFA (Radio Frequency Ablation) or prior SIRT (Selected Internal Radio Therapy) within one year before inclusion.
The Effect of Cognitive Behavioral Therapy on Post-Traumatic Stress Symptoms in Nursing Students

Objectives: This research was planned to examine the effect of cognitive behavioral therapy on the post-traumatic stress symptoms of nursing students during the COVID-19 pandemic.

Design: Single-blinded study with parallel groups. Setting: Faculty of Nursing. Participants: 60 first-year students studying at the Faculty of Nursing were randomly assigned to the intervention (n=30) and control (n=30) groups.

Method: Data were collected using the Information Form prepared by the researcher and the Post Traumatic Stress Disorder Checklist for DSM-5. The intervention group was collected online three times, before the cognitive behavioral group therapy, at the end of the therapy and three months later. Group intervention program based on cognitive behavioral approach of ten sessions; face-to-face, the intervention group was divided into two separate groups and each group was completed in approximately one and a half months (May-June 2022), two days a week. Follow-up measurement was completed in September 2022. While group therapy was applied to the intervention group, no intervention was made to the control group.


Eligibility Criteria:
Inclusion Criteria:

* Being a first year nursing student

Exclusion Criteria:

* Being a foreign student
* Having a psychiatric diagnosis
Monthly And Twice Monthly Subcutaneous Dosing Of PF-04950615 (RN316) In Hypercholesterolemic Subjects On A Statin

To evaluate the Low Density Lipoprotein-Cholesterol (LDL-C) lowering effect of PF-04950615 administered subcutaneously at monthly intervals, or twice monthly intervals in subjects with high cholesterol whose LDL-cholesterol is \>/=80 mg/dL on background treatment with a statin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be receiving a stable dose (at least 6 weeks) of any statin and continue on same dose of statin for the duration of this trial.
* Lipids should meet the following criteria on a background treatment with a statin at 2 screening visits that occur at screening and at least 7 days prior to randomization on Day 1:
* Fasting LDL-C greater than or equal to 80 mg/dL (2.31 mmol/L);
* Fasting TG less than or equal to 400 mg/dL (4.52 mmol/L).
* Subject's fasting LDL-cholesterol must greater than or equal to 80 mg/dL (2.31 mmol/L at the initial screening visit, and the value at the second visit within 7 days of randomization must be not lower than 20% of this initial value to meet eligibility criterion for this trial.

Exclusion Criteria:

* Participation in other studies within 3 months before the current study begins and/or during study participation.
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
* Pregnant females; breastfeeding females; males and females of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 63 days after last dose of investigational product.
* History of a cardiovascular or cerebrovascular event or procedure (eg, MI, stroke, TIA, angioplasty) during the past 6 months. Congestive heart failure (CHF), NYHA functional classes III or IV.
* Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%).
* Poorly controlled hypertension.
Multicentre Clinical Trial. Project EXIMe

Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid.

Genitourinary Syndrome of Menopause is a common condition that increases by four the risk of having a sexual dysfunction, and that affects the quality of life of women who suffer it. Those women with an active sexual life have fewer symptoms associated with this syndrome. Objective: to evaluate the effectiveness of an individualized intervention in sexual health conducted in the midwife consultation to improve the quality of life in women with Genitourinary Syndrome of Menopause. Design: Multicentre randomized clinical trial with groups in parallel, controlled single-blind, with blind evaluation of the response variable, held in the Community of Madrid. Population: women aged between 45-65 years with Genitourinary Syndrome of Menopause attending to the midwife consultation. N= 250 (125 women in each group) will be included by midwifes in the Primary Health Care consultations in the Community of Madrid. Control group: women will receive the usual assistance.

Experimental group: in addition to the usual assistance, women will receive a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used. Variables: Main-Quality of life in menopause (measured with the Cervantes Short-Form Scale). Secondary- sociodemographic variables, sexual history and variables related to the Genitourinary Syndrome of Menopause. Analysis: by intention-to-treat, comparing the quality of life in menopause scores before/after the intervention in both groups after 0, 1 and 6 months. To explain the factors associated with a higher quality of life, a linear regression model would be fitted.

Eligibility Criteria:
Inclusion Criteria:

* women aged between 45-65 years with Genitourinary Syndrome of Menopause

Exclusion Criteria:

* women who present pathologies that lead to an alteration of sexual desire
* women who receive or have received in the last six months treatment that increase the incidence of vaginal atrophy
* women who receive or have received local hormonal therapy during the last month, systemic hormonal therapy in the last six months, or other systemic treatment for the Genitourinary Syndrome of Menopause
* women who could not read or write, and not understand the spanish language.
Study Evaluating the Effect of Isonatremic Dialysis Treatment in Chronic Kidney Disease Patients on Dialysis

Aim of this study is to evaluate, in a population of chronic kidney disease patients on dialysis (Stage 5D), the effect of treatment with isonatremic dialysis (vs conventional dialysis), during an observational period of 2 months each, on:

* control of interdialytic weight gain
* perdialytic tolerance in terms of adverse events occurring during all of the sessions of the study
* body composition and thirst measured monthly during the 4 months of follow-up.
* tolerance to treatment.


Eligibility Criteria:
Inclusion criteria:

* Chronic Kidney Disease patient on dialysis (stage 5D)
* With plasma sodium concentration between 130 and 140 mmol/L
* Anuric
* Patient dialysed with dialysis machine allowing isonatremic dialysis treatment

Exclusion criteria:

* Patient with plasma sodium concentration below 130 or above 140 mmol/
* Pacemaker
To Evaluate Eye Installation-Tear Free

The primary objective of this study was to compare the human eye stinging potential of experimental formulas of sun care products \[Sun Protection Factor (SPF) 50 Y49 091, SPF 50 X15 158, SPF 50 X15 160 and SPF 50 X57 162 compared to an industry standard shampoo mixture.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, 18 to 60 years with no medical conditions of the eyes as determined by the subject's medical history and confirmed by an ophthalmologist
* Subjects not under any doctor's care for ocular or peri orbital diseases
* The subject will refrain from using contact lenses, any topical facial products, any eye drops, false eyelashes, make up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.
Extended Release Nifedipine Treatment as Maintenance Tocolysis to Prevent Preterm Delivery

To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group.

The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.


Eligibility Criteria:
Inclusion Criteria:

* pregnancy week 24-33
* Singleton pregnancy
* After successful treatment to stop PTL

Exclusion Criteria:

* Contraindications for Nifedipine extended release treatment.
Autologous CARTmeso/19 Against Pancreatic Cancer

Pancreatic cancer patients receive chimeric antigen receptor (CAR) T cells against mesothelin (CARTmeso) or CD19 (CART19) cells administered at 3 days via pancreatic artery infusion or i.v. after preconditioning of cyclophosphamide. Both CART cells are autologous. CARTmeso cells target pancreatic cells which highly express mesothelin, while CART19 cells target tumor-associated B cells expressing cluster of differentiation antigen 19 (CD19) which are mostly immunosuppressive. The investigators hypothesize that this combination therapy may enhance the efficacy of CARTmeso cells in the body. Additionally, a medium dose of cyclophosphamide is used to enhance the engraftment of CART cells.

This is a single arm, open-label, pilot study to determine the safety and feasibility of combination CARTmeso cells and CART19 cells in patients with pancreatic cancer following lymphodepletion with cyclophosphamide. Both cells contain CAR proteins consisting of a murine-derived single chain antibody fragment (scFv), cluster of differentiation antigen 137 (41BB) co-stimulatory domain and cluster of differentiation antigen 3 zeta chain (CD3ζ) signaling domain transduced by lentivirus

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* serum soluble mesothelin-related protein (SMRP) \> 0.4 nanomolar/L
* Persistent cancer after at least one prior standard of care chemotherapy for advanced stage disease

  * 18 years of age and ≤65
* Life expectancy greater than 3 months
* Satisfactory organ and bone marrow function

Exclusion Criteria:

* Participation in a therapeutic investigational study within 4 weeks prior to the screening visit
* Active invasive cancer other than pancreatic cancer
* HIV, hepatitis B/C virus, or infections
* Active autoimmune disease requiring immunosuppressive therapy within 4 weeks
* Planned concurrent treatment with systemic high dose corticosteroids
* Patients requiring supplemental oxygen therapy
* Pregnant or breastfeeding women
Liberal Versus Goal-directed Intraoperative Fluid Therapy in Pediatric Patients

The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.

Liberal regimen = maintenance fluid(4/2/1) + deficit fluid + replacement of third space loss (\>,=10ml/kg/h) Goal directed therapy regimen = maintenance fluid + deficit fluid + fluid replaced by hemodynamic monitoring guided.

Eligibility Criteria:
Inclusion Criteria:

* Body weight \< 15 kg
* Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified
* ASA \< or = 3
* Duration of surgery \> or = 2 hours

Exclusion Criteria:

* Cardiopulmonary disease
* Renal insufficiency
* Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
* reoperation
Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Total knee arthroplasty (TKA) is increasingly common in the treatment of knee osteoarthritis. TKA is associated with moderate to severe postoperative pain, causing patient discomfort, mobilisation and hospital discharge.

Continuous epidural analgesia is often used for controlling pain after TKA. Recent studies describe a new method for pain control after total knee arthroplasty which consists of local infiltration with local anesthetics and adrenaline. This infiltrations can be combined with ketorolac and/or morphine. The aim of this study is to:

1. Compare analgetic efficacy of to types of local infiltration analgesia in total knee arthroplasty.
2. Compare analgetic efficacy of local infiltration analgesia with continuous epidural analgesia.

Eligibility Criteria:
Inclusion Criteria:

* patients at least 18 years of age
* scheduled for elective total knee arthroplasty
* ASA I-III
* signed written informed consent

Exclusion Criteria:

* age \< 18
* ASA \> III
* moderate or severe cardiac disease, bronchial asthma
* allergy against ropivacaine, ketorolac or morphine
* analgetic abuse
* pregnancy or nursing women
* severe psychiatric disease
* moderate to severe dementia
The Effect of Tranexamic Acid on Postoperative Blood Loss and Coagulation in Patients With Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; Double Blind Randomized Control Study

The Effect of Tranexamic Acid on Postoperative Blood loss and Coagulation in Patients with Preoperative Anemia Undergoing Off-Pump Coronary Artery Bypass Graft; double blind randomized control study.


Eligibility Criteria:
Inclusion Criteria:

* Fifty patients undergoing OPCAB with preoperative hematocrit levels lower than 35%

Exclusion Criteria:

Patient who has

* Open heart surgery history before
* Thrombosis history
* Myocardial infarction (MI) within 7days recently
* Liver or Kidney disease
* been scheduled emergency surgery
Lay Health Coaches for Weight Loss: Peers Versus Mentors

The primary aim of this study is to determine whether reduced intensity behavioral weight loss treatment (rBWL) + Peer Health Coaches yields significantly greater weight loss than rBWL + Mentor Health Coaches and rBWL alone.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 30 and 40
* Age between 40 and 60 years
* English speaking

Exclusion Criteria:

* Are unwilling to communicate regularly with a weight loss coach
* Report not being able to walk 2 blocks (1/4 mile) without stopping
* Are currently participating in a weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 5% of body weight during the past 6-months
* Are pregnant, lactating, less than 6-months post-partum, or plan to become pregnant during the intervention timeframe
* Report a heart condition, chest pain during periods of rest or activity, or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that would jeopardize their safety if involved in a weight management program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render the participant unlikely to follow the study protocol (e.g., relocation, dementia, terminal illness, substance abuse).