cyrilzakka/clinical-trials huggingface dataset:
The Use of ACE Inhibitors in the Early Renal Post-transplant Period

Chronic allograft nephropathy (CAN) is the leading cause of longterm renal transplant loss. Angiotensin-II may play a role in the development and progression of CAN. Angiotensin converting enzyme inhibitors (ACEI) comprise a drug class that inhibit the effects of angiotensin-II. However these drugs have been reported to cause elevated potassium and creatinine levels in some renal transplant patients. Yet, there are now several retrospective reports of long term benefits of improved renal function and graft survival in renal transplant recipients. There have been no reports of prospective randomized controlled trials of ACEI in renal transplant patients in the early post transplant period.

The purpose of the present study is to assess the safety of enalapril, a drug in the ACEI class, when started 1-3 month post transplant. This is a double-blinded, randomized control trial of enalapril vs. placebo in new renal transplant patients with serum creatinine values no higher than 2.5mg/dl and normal serum potassium levels. The study drug will be administered for 6 months. Patients will be monitored in the renal transplant clinic every 1-4 weeks according to routine protocol. Clinical end-points will be occurence of potassium \>5.9mEQ/L or sustained increase in serum creatinine \>30% from baseline.

All new renal transplant recipients with functioning allografts and serum creatinine less than 2.6 mg/dl within the first 3 month post transplant would be eligible for this study of the safety of enalapril 5 mg vs placebo. Patients with serum potassium persistently over 5.5 mEQ/L would be excluded. This is a double-blinded randomized control study. End-points of the study are a persistent rise in serum creatinine of \>30% from baseline not otherwise explained by clinical evaluation, and persistent serum potassium \>5.9mEQ/L. Study duration is 6 month. At the end of the study patients will be continued on ACEI if clinically stable

Eligibility Criteria:
Inclusion Criteria:

* New adult renal transplant recipients with good renal function defined as serum creatinine less than 2.6 mg/dl,
* Normal serum potassium levels,
* No contraindication to ACE inhibitor use

Exclusion Criteria:

* Renal transplant patients with persistent serum creatinine levels over 2.5 mg/dl
* Hyperkalemia with serum potassium levels over 5.5 mEQ/dl
* History of allergic reaction to ACE inhibitors or angiotensin receptor blockers
* Pregnancy
Long Term Prevention of Nausea and Vomiting in Gynecologic Laparoscopy

To compare postoperative nausea and vomiting (PONV) and perioperative outcomes of gynecologic patients undergoing laparoscopic surgery after scheduled administration of intravenous Ramosetron during hospital stays.

* Randomized controlled arm : Placebo versus Ramosetron injection
* Administration schedule : immediate postoperative status, 12 hrs after surgery, 36hrs after surgery

Surgical outcomes including operative time, blood loss, Hb change, postoperative pain, nausea/vomiting scale, times of rescue therapy, and complications

Eligibility Criteria:
Inclusion Criteria:

* Age: 18\< or =, = or \<70 with benign gynecologic disease
* ASA-Class I-II
* No-definite malignancy by US, CT/MRI, CA 125 \< 500IU/ml
* Non-smoker

Exclusion Criteria:

* Conversion to laparotomy
* Hx of malignancy
* Smoker
* Suspicious malignancy
To Compare Safety and Pharmacokinetic Properties of CJ-30039 and Lipidil Supra

To investigate the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra

Study objectives

* To compare the safety and pharmacokinetic properties of CJ-30039 and Lipidil Supra after a single oral administration in healthy male volunteers.
* To evaluate the food-effect on pharmacokinetics of CJ-30039 after a single oral administration in healthy male volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Male volunteers in the age between 20 and 55 years old
* BMI(Body Mass Index) in the range of 18.5 to 25kg/m2
* Subject with no history of any significant chronic disease

Exclusion Criteria:

* History of clinically significant allergies, including fenofibric acid or Fenofibrate
* History of clinically significant hepatic, renal, neurology, psychiatric, pulmonary, endocrine, hematologic, cardiovascular disease
* History of surgery except or gastrointestinal disease which might significantly change absorption of medicines
* Clinical laboratory test values are outside the accepted normal range

  * AST(ASpartate Transaminase), ALT(ALanine Transaminase)( \> 1.25 times to normal range
  * Total bilirubin \> 1.5 times to normal range
  * BUN(Blood Urea Nitrogen) \> 25 mg/dL or Creatinine \> 1.4 mg/dL
  * CK(Creatine Kinase) \> 1.25 times to normal range
* Estimated GFR(Glomerular Filtration Rate) \< 80 mL/min/1.73m2
* Clinically significant vital sign

  * SBP(Systolic Blood Pressure) ≤ 90 mmHg or SBP ≥ 150 mmHg
  * DBP(Diastolic Blood Pressure) ≤ 50 mmHg or DBP ≥ 100 mmHg
* History of drug abuse or positive urine screen for drugs
* History of caffeine, alcohol, smoking abuse

  * caffeine \> 5 cups/day
  * alcohol \> 201g/week
  * smoking \> 10 cigarettes/day
* Use of prescription only medicine and oriental medicine within the 14 days before dosing or use of non-prescription medicine within the 7 days before dosing
* Participated in a previous clinical trial within 60 days prior to dosing
* Donated blood within 60 days prior to dosing
An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension

This study evaluates the impact of a fully digital, autonomous, and artificial intelligence (AI)-driven lifestyle coaching program on managing blood pressure (BP) among adults diagnosed with hypertension. Participants received a BP monitor and a wearable activity tracker to facilitate data collection. This data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. The program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective BP management.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Stage 2 hypertension based on their most recent clinical measurement (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg per the 2017 American College of Cardiology/American Heart Association guidelines)
* Speaking and reading English
* Having an Apple iPhone 6s or later, or an Android phone running Android 8.0 or later

Exclusion Criteria:

* Self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
* Current participation in a lifestyle modification program or research study
* Self-report of being currently pregnant
Reliability and Validity of the Spinal Cord Injury Secondary Conditions Scale

People living with spinal cord injury (SCI) experience a range of secondary health conditions that impact their quality of lives. The Spinal Cord Injury Secondary Conditions Scale (SCI-SCS) is a 16-item questionnaire that assess secondary health conditions in persons with SCI. The total score of SCI-SCS range from 0 to 48 and is derived by adding the scores for each item. Higher scores indicate greater problems with secondary conditions. The investigators aimed to determine the reliability and cross-cultural validation of the Turkish translation of the SCI-SCS.

After translation and back translation of the SCI-SCS, 93 patients between the ages of 18 and 78 years with SCI, American Spinal Injury Association impairment scale grades from A to D and at least 6 months after injury were assessed. Participants rated the SCI-SCS 2-3 day apart, and test-retest agreement was investigated. Factor analysis was done and convergent validity was investigated by correlating the SCI-SCS with the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET), Functional Ambulation Categories (FAC), 36-Item Short Form Health Survey (SF-36), and Spinal Cord Independence Measure III (SCIM-III).

Eligibility Criteria:
Inclusion Criteria:

Patients between the ages of 18 and 80 years with SCI, American Spinal Injury Association impairment scale grades from A to D and at least 6 months after injury. Those who volunteered to participate in the study.

Exclusion Criteria:

* Patients with SCI for less than 6 months
* Patients with impaired cognitive functions,
* Patients with other neurological diseases,
* Patients with malignancy
Prevalence of Abnormal Postures in Parkinson's Disease

Postural abnormalities represent disabling and painful complications in patients with Parkinson's disease (PD). The stooped posture is a typical feature of PD but with advancing of disease more severe body abnormalities can affect people with PD. These deformities include Pisa syndrome, camptocormia, antecollis, scoliosis and striatal deformities related to hand (striatal hand) and/or toes (striatal toes).

Postural abnormalities represent disabling and painful complications in patients with Parkinson's disease (PD). The first postural trunk deviation in PD was first described by James Parkinson himself and recognized as stooped simian appearance, with flexion of the hips and knees, and rounding of the shoulders. Although the stooped posture is a typical feature, more severe spinal misalignment (and deformities) can affect people with PD. These postural deformities include Pisa syndrome (PS), camptocormia (CP), antecollis (AC), scoliosis (S) and striatal deformities related to hand (striatal hand) and/or toes (striatal toes). The prevalence of these postural deformities is variable because several diagnostic criteria have been used to characterize each deformity. Recently, a consensus of diagnostic criteria has been reached in literature permitting us to better mapping the presence of these deformities in people with PD.

Eligibility Criteria:
Inclusion Criteria:

1. Participants will be considered enrolled after signing the consent form;
2. Diagnosis of Parkinson's disease;

Exclusion Criteria:

1. Concomitant neurologic diseases known to negatively affect posture;
2. A history of major spinal surgery or muscle and/or skeletal diseases;
3. Treatment with drugs potentially able to induce abnormal postures;
4. Clinical features consistent with a diagnosis of atypical parkinsonism;
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma

Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with advanced epithelial cancer, malignant lymphoma, or sarcoma

PRIMARY OBJECTIVES:

I. Determine the dose-limiting toxicity and maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with advanced epithelial cancer, malignant lymphoma, or sarcoma.

II. Determine the significant toxic effects associated with this drug in these patients.

III. Determine the response in patients treated with this drug. IV. Determine the pharmacokinetics of 17-AAG and 17AG in these patients.

OUTLINE: This is a dose-escalation study. Patients receive treatment according to 1 of 2 schedules.

Schedule B: Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1-2 hours twice weekly for 3 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Schedule C: Patients receive 17-AAG IV over 1-2 hours twice weekly for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

In both schedules, cohorts of 3-6 patients receive escalating doses of 17-AAG until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. At least 6 patients receive treatment at the MTD.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced epithelial cancer, malignant lymphoma, or sarcoma for which no standard curative therapy exists
* Brain metastases allowed after definitive radiotherapy
* Performance status - ECOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 2 times normal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 60 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for at least 1 week before, during, and for at least 2 weeks after study completion
* No active infection
* No other serious concurrent condition
* No prior allergic reaction to egg products
* At least 4 weeks since prior biologic therapy (regional or systemic)
* At least 4 weeks since prior chemotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy
A Retrospective Case Series Study for Acute Abdomen in General Surgery Ward

The acute abdomen is a clinical situation in which an acute an change in the condition of intra-abdominal organ, commonly attached to inflammation or infection need urgent and correct diagnosis .

A special data collection sheet designed to collect data regarding the diagnosis, age and sex from the profile of patients retrospectively. Data entry was performed by using Microsoft Excel and all the data were analysed by SPSS.

Eligibility Criteria:
Inclusion Criteria:

* All of patients with acute abdomen that is admitted in general surgery ward of Aliabad teaching hospital.

Exclusion Criteria:

* traumatic abdominal injury, abdominal pain due to urological and gynaecological origin.
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.

Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment of breast cancer and will be randomized to a treatment group to receive either upfront zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4 mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Stage I-IIIa breast cancer
* Postmenopausal or recently postmenopausal
* Recent surgery for breast cancer
* Estrogen Receptor positive and/or progesterone receptor positive hormone receptor status
* No prior treatment with letrozole

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Metastatic disease
* Invasive bilateral disease
* Clinical or radiological evidence of existing fracture in spine or hip
* Prior treatment with IV bisphosphonates in the past 12 months
* Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of baseline evaluation)
* Use of Tibolone within 6 months
* Prior use of parathyroid hormone for more than 1 week
* Previous or concomitant malignancy
* Abnormal renal function
* History of disease effecting bone metabolism

Other protocol-defined exclusion criteria may apply.
Accute Effect of B-Turmactive Both on Mild and Moderate Knee Pain on Healthy Volunteers

The goal of this study is to assess the short (acutte) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain

Join pain is a common cause of consultation in primary health care in the adult population. Indeed, people who suffer knee pain, mostly due to osteoarthritis, require analgesic treatment, often with some secondary effects. Therefore, the research to find a natural and efficient product to reduce knee pain in a short period of time, facilitating recovery after exercise and without side effects have an interest both for industry and for the general population.

B-turmactive is an extract of Curcuma longa mixing two fractions in a single product: a) soluble fraction free-curcuminoids but rich in polysaccharides and b) curcuminoids fraction with cyclodextrin. Both fractions plus vitamin C are B-turmactive.

Previous preclinical studies suggest that B-turmactive could exert an acute effect in healthy people that suffer mild or moderate knee pain and, furthermore could reduce inflammation process.

Therefore, the goal of this study is to assess the short (acute) effect of B-Turmactive (one week treatment) both on mild/moderate knee pain

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 30 and 65 years old.
* Score between 15-25 out of 50 within WOMAC pain subscale
* Signed informed consent.

Exclusion Criteria:

* people who take concomitant drug or supplements (multivitamins) that could interfere with the product under study.
* people who suffer froma arthritis of the knee.
* people who take more than two analgesic drugs and/or anti-inflammatory for more than three months.
* people who have a history of surgery or trauma affecting the knee.
* people with gluten sensitivity and/or allergy to gluten and sulphites (the placebo containing yeast).
* people with anemia (haemoglobin ≤ 13g/dL in men and ≤ 12g/dL in women).
* people with BMI ≥ 30 kg / m
* women pregnant or breastfeeding.
* women with menopausal suffering from osteoporosis.
* people with liver abnormalities (ALT, AST), kidney (creatinine) or other muscular issues (creatine kinase).
* people with neurological disorders.
* people who have participated in a clinical trial or intervention study the last 30 days prior to inclusion in the study.
* people unable to follow the guidelines of the study.
* people who not signed the informed consent.
Evaluation of PCR Using DNA Extract From Slides and Filter Paper for the Detection of Tuberculosis and MDR-tuberculosis

Specimen transport from peripheral health structures to the National TB reference laboratory for MDR-TB identification presents a big challenge in term of sample management, safety, contamination and delays. Thus a system that allows specimen to be collected and shipped in a safely manner while reducing the possibilities of contamination, the cost of shipment and especially the time for detection of MDR-TB by using molecular methods would be very useful. Whereas the some studies show promising results for the development and standardization of simple specimen collection and transportation methods for molecular DST, more data is needed before these can be used in routine.

The study described here aims at identifying a suitable method, in terms of adapted sample support (s) (slide, filter paper (FTA, Genocard ...)) and DNA extraction method. If one or several methods are found to give satisfying results, then a larger patient based evaluation of this (these) method(s) for molecular DST will be performed in a second phase. The protocol for the second phase will be prepared separately.

The main objective of this study is to evaluate the performance of PCR in identification and detection of tuberculosis using DNA extracts from stained slides (Ziehl Neelsen and Fluorescence) and Filter paper (FTA card and Genocard).

The secondary objectives of this study are to assess the MTB extraction yield from smear-negative, low and high bacilli load specimens on slides, filter paper ( Genocardand FTA), to determine the amount of sample required to make a detectable PCR reaction and to assess the feasibility of storage and extraction methods.

Eligibility Criteria:
Inclusion Criteria:

* TB suspect with cough more than 2 weeks

Exclusion Criteria:

* None
Goal Directed Therapy for Acute Kidney Injury in Critical Ill Patients

Acute kidney injury (AKI) is a frequent complication in critically ill patients admitted to intensive care unit (ICU) and it is associated with increased morbimortality.

There is evidence that perioperative hemodynamic optimization decreases the incidence of AKI in the post operative phase in high-risk patients. We aimed to evaluate if the use of a goal-directed therapy to increase oxygen delivery in the early phase of acute kidney injury can decrease the prevalence of patients with acute renal failure.

Randomized, controlled, multicenter study.The intervention group was monitored with Flo Trac/Vigileo and optimized with fluid challenges, dobutamine and blood transfusion, if necessary, to maintain a IDO² ≥600ml/min/m² during 8h. The control group was treated according to the discretion of the attending physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the Intensive Care Unit with Acute Kidney Injury (AKI) classified as AKIN 1 (increase in serum creatinine ≥0.3 mg/dL and/or urine output less than 0.5 ml/kg/h over 6 hours) for less than 12 hours.

Exclusion Criteria:

* ICU length of stay \>10 days, nefrectomy, chronic kidney disease undergoing hemodialysis, baseline creatinine ≥4 mg/dL, life expectance ≤ than 1 month, pregnancy, severe arrhythmia, severe heart failure (≤ III, NYHA), acute myocardial infarction (AMI)
To Evaluate the Effect of Reveratrol,Folic Acid, Vitamin D, Vitamin B12 and B6 in Male Infertility

The objective of this study is to evaluate the impact of the Genante(TM) on the spermiogram parameters in infertile male patients

This is a single-centre prospective observational study. Twenty infertile male patients.

Inclusion criteria are:

Age:18-50 years oligozoospermia: \< 5 million spermatozoa/mL; asthenozoospermia: \< 32% progressive motile spermatozoa; teratozoospermia: \< 4% normal forms.

Esclusion criteria:

Patients with azoospermia, who smoke, use drugs, drugs with proven fertility toxicity, exposed to any environmental or occupational toxic substances, radiation or heat; with orchitis secondary to mumps, sexually transmitted diseases, history of cryptorchidism, previous testicular torsion, genitourinary anomalies, alterations of the epididymis or deferens; and inguinal surgery

Pretreatment evaluation included:

Semen analysis Hormonal determinations:follicle-stimulating hormone (FSH) and luteinising hormone (LH) total Testosterone Total,estradiol, prolactina, 25-OH-Vitamin D3); scrotal ultrasound prostatic transrectal ultrasound

Outocmes measures (baseline, at 1 and 6 months):

* Semen volume (mL)
* Total sperm number (106/ejaculate)
* Sperm concentration (106/mL)
* Total motility (PR + NP)
* Progressive motility (PR, %)
* Vitality (live spermatozoa, %)
* Sperm morphology (normal forms, %)
* Ph
* FSH
* LH
* Testosterone totale
* Estradiol
* Prolactiona
* 25-OH-Vitamin D3
* scrotal ultrasound
* prostatic transrectal ultrasound

Eligibility Criteria:
Inclusion Criteria:

* male 18-50 years
* oligozoospermia: \< 5 million spermatozoa/mL;
* asthenozoospermia: \< 32% progressive motile spermatozoa;
* teratozoospermia: \< 4% normal forms.

Exclusion Criteria:

* azoospermia
* smoke
* use drugs
* use drugs with proven fertility toxicity
* exposition to any environmental or occupational toxic substances
* exposition to radiation or heat
* orchitis secondary to mumps
* sexually transmitted diseases
* history of cryptorchidism
* previous testicular torsion
* genitourinary anomalies
* alterations of the epididymis or deferens
* inguinal surgery