cyrilzakka/clinical-trials huggingface dataset:
A Pilot Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

The 2 × 2 crossover designed study is to evaluate the bioequivalence of two different amphotericin B liposome for injection after single IV infusion at the same dose in normal healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects fully understand and voluntarily participate in this study and sign informed consent.
2. Healthy female and male volunteers aged 18-55 years.
3. Body weight ≥ 50 kg for male and ≥ 45 kg for female with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m2 (inclusive).
4. Subjects must be in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion Criteria:

1. History of allergic reactions to amphotericin B or its analogs. History of allergy to two or more kinds of drugs or food.
2. Subjects have any history of surgery, trauma that may affect the safety of the study or the intracorporal process of the drug, or have a surgical schedule during the study period.
3. Use of any prescription or over the counter medication within 14 days prior to screening.
4. History of drug abuse within 6 months prior to screening.
5. Smoking more than 5 cigarettes per day within 3 months prior to screening, or unable to stop using any tobacco products during the trial period.
6. Consumption of alcohol in excess of 14 units/week within 3 months prior to screening.
7. Consumption excessive amounts of tea, coffee and/or caffeine-rich beverages daily within 3 months prior to screening.
8. Participation in other trial within 3 months prior to screening.
9. Donation or loss of more than 400 mL blood within 3 months prior to screening.
10. Subject (female) is lactating or pregnant.
11. Subject who cannot tolerate venipuncture or have a history of needle and blood sickness.
12. Subject who has special requirements on diet and cannot accept the uniform diet.
13. Subject who has childbearing plan, unwillingness or inability to use effective contraceptives from 2 weeks before the screening to 6 months after the last dosing of the study drug.
14. Any positive test result for Hepatitis B surface antigen, hepatitis C virus antibody, anti-human immunodeficiency virus antibody or anti-syphilis spirochete.
15. Female subjects with positive pregnancy test results during the screening period or during the study.
16. Positive test result for alcohol screening or drug abuse.
17. AST or ALT, total or direct bilirubin, alkaline phosphatase and creatinine are above the upper limit of normal and potassium is below the lower limit of normal; any other abnormalities in laboratory tests and ancillary tests that are judged by the investigator to be clinically significant.
18. Not suitable for this study as determined by the investigator due to other reasons.
Air Quality Monitoring and Health Surveillance of Workers in the Photocopier Units

To monitor air quality in selected photocopier units and to assess the health status of workers who are exposed to emissions from photocopiers.


Eligibility Criteria:
Inclusion Criteria:

* at least 2 years of exposure to photocopiers

Exclusion Criteria:

* any clinical abnormality
Intestinal Tuberculosis Diagnostics and the Differentiation From Crohn's Disease

One aims to devise a method for the screening and differentiation of intestinal tuberculosis and Crohn's Disease. Additionally, one aims to detect and survey multidrug resistant TB.

Intestinal tuberculosis (ITB) and Crohn's disease (CD) may present identically; the consequence of misdiagnosing and mistreating one disease for the other may be grave. CD is on the increase worldwide while TB re-emerges in areas of low TB endemicity. Current diagnostic guidelines evolve from research in areas with low TB prevalence, thereby being inappropriate in TB endemic regions. To date, no simple or non-invasive methods exist to diagnose ITB and to differentiate it from CD.

One aims to devise a method for screening and differentiation of the two diseases. By using non-invasive rapid tests one wishes to make diagnostics available to resource poor settings. Ideally, referrals to invasive diagnostic procedures would decrease, thus liberating economic and staff resources. Furthermore, patients may avoid unnecessary, expensive and often inconclusive advanced procedures. Additionally, one aims to detect and survey multidrug resistance caused by empiric TB treatment, which in itself obscures ITB diagnosis.

This case control study matches 50 ITB patients and 50 CD patients with 100 healthy controls in India, and 50 CD patients with 100 healthy controls in Norway. Comparative statistical analysis will be carried out. Challenges include patient adherence and sample handling. Non-TB gastrointestinal infections may confound the results and will be adjusted for.

Recently published data suggests that the serum/faecal calprotectin ratio may be used to discriminate ITB from healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age.
* ITB as per standard criteria a), and one or more of b) to e) must be fulfilled (Gold standard):

  1. Endoscopic apparent intestinal tuberculosis: transverse ulcers, pseudopolyps, involvement of fewer than four intestinal segments, patulous ileo-coecal valve
  2. Histological evidence of tubercles/granulomas with caseation necrosis in intestinal biopsies
  3. DNA of M.tb detected by PCR of intestinal biopsies
  4. Positive immunohistochemistry in intestinal biopsies.
  5. Histological demonstration of acid fast bacilli in a lesion.
* Active Crohn's disease as per standard criteria (Gold standard), at least two of the following:

  1. Clinical: inflammatory, perforating (fistulising) disease, obstructive symptoms secondary to small bowel stenosis or stricture.
  2. Endoscopic: deep linear or serpingenous ulcerations, discrete ulcers in normal appearing mucosa, cobble-stoning or discontinuous or asymmetrical inflammation.
  3. Radiographic: segmental disease (skip lesions), small bowel or colonic strictures, stenosis or fistula.
  4. Histological: sub-mucosal or transmural inflammation, granulomas, focal cryptitis and chronic inflammatory infiltration, skip lesions including rectal sparing (no topical rectal therapy).

Exclusion Criteria:

a) Age below 18 years b) HIV positive c) Malignancy
Urinary Prostaglandin E Metabolite (PGE-M), A Metabolite of Prostaglandin E2 (PGE2): A Novel Biomarker of Crohn's Disease Activity

The purpose of this study is to determine whether urinary PGE-M levels correlate with Crohn's disease activity and to compare how well urinary PGE-M correlates with other non-invasive biomarkers of disease activity such as C-reactive protein (CRP) and fecal calprotectin.

The available clinical measures of Crohn's disease activity can be overly influenced by functional symptoms. Placebo response rates in clinical trials are high. Several non-invasive biomarkers are currently available for assessing inflammatory bowel disease (IBD) disease activity including erythrocyte sedimentation rate, C-reactive protein and fecal calprotectin. Although these markers hold some promise, their performance is less than ideal. What is needed is a simple, non-invasive, biologic measure of Crohn's disease.

Cyclooxygenase-2 (COX-2) is involved in prostaglandin E2 (PGE2) synthesis and is expressed in epithelial inflammatory conditions and some cancers. We have developed an assay to quantify the major urinary metabolite of PGE2, PGE-M. PGE-M has been previously shown to be elevated in the urine of patients with advanced colorectal neoplasia relative to controls.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient male or female 18 years or older
* Confirmed diagnosis of Crohn's disease
* Informed consent obtained
* Able to give blood, urine and stool samples
* Willing to undergo a diagnostic colonoscopy as part of routine Crohn's disease care

Exclusion Criteria:

* Unable to give consent
* Ulcerative colitis
* Does not meet inclusion criteria
* Pregnant
Comparison of Regional Manual Therapy and Standard Physical Therapy Intervention in Females With Sacroiliac Joint Pain

The SIJ has long been considered an important source of low back pain because of the empirical ﬁnding that treatment targeting the SIJ can relieve pain.This study was be a Randomized Clinical Trail conducted at Riphah Rehabilitation Centre Lahore. The study was be completed within the time duration of Six months. Purposive sampling technique was be used. Sample size is calculated by using the G power 3.1. The sample size of 64 patients was be taken in this study to find the comparison of regional manual therapy and standard physiotherapy intervention in females with sacroiliac joint pain. Patients was be divided into two groups.. Patients was be divided into two groups. Group A was be treated with regional manual therapy. In regional manual therapy patients was be given mobilization to lumber region and SIJ, pelvic floor exercises and core strengthening exercises and Group B was be treated with standard physiotherapy in which patients was be given SIJ mobilization and Straight leg raise. Both groups was receive transcutaneous electrical nerve stimulator and heating pad as a common treatment protocol. Numeric pain rating scale (NPRS) and oswestry low back disability questionnaire was be used as Data collecting tools. Two session of treatment per week for eight weeks was be given. Data was be analyzed on SPSS 21.


Eligibility Criteria:
Inclusion Criteria:

* Females with sacroiliac joint pain
* Age: 20 to 50 years

Exclusion Criteria:

* Patients withany red flag signs i.etumor, fracture, metabolic diseases, rheumatoid arthritis, prolonged history of steroids use, etc.
* Females with sciatica
* Females with radiating pain
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) in Epithelial Ovarian Cancer

Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.


Eligibility Criteria:
Inclusion Criteria:

Female patients diagnosed with epithelial ovarian cancer (By histopathology)

Age ≥ 18 years old

Advanced defined as (stage 2D or more ) by surgical staging.

Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2

Chemotherapy naïve

Informed consent

Exclusion Criteria:

Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.

Patients with uncontrolled infection.

Patients with active bleeding or conditions associated with high risk of bleeding.

contraindications for surgery

contraindications To chemotherapy - bevacizumab
Pancreatic Stone Protein (PSP) in Pregnant Women

This prospective, single centred cohort study evaluates the physiological course of the potentially novel biomarker PSP in pregnant women as well as its predictive role in the development of inflammatory complications during pregnancy.

Pregnant women feature a complex immunological condition caused by pregnancy itself and hence women present with an increased susceptibility to some infectious and non-infectious inflammatory diseases. Specifically regulated mechanisms have been described occurring in normal whereas lacking in pathological pregnancies in both the native and adaptive immune system in animal models and humans. However, clinically relevant biomarker associated with preterm premature rupture of membranes (PPROM), amniotic infection syndrome (AIS) as well as pregnancy associated complications such as preeclampsia and hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome have their limitations.

Pancreatic stone protein (PSP), originally obtained from human pancreatic stones from patients operated for chronic calcifying pancreatitis, has been studied in several gastrointestinal pathologies.

The aim of this study is to evaluate the physiological course of the potentially novel biomarker PSP in pregnant women as well as to assess its predictive role in the development of inflammatory complications during pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Healthy women with single pregnancy
* Women with PPROM, AIS, preeclampsia, or HELLP syndrome
* Patients able to provide informed consent

Exclusion Criteria:

* Viral (hepatitis B virus, hepatitis C virus, human immunodeficiency virus) or confirmed bacterial infections
The Effect of Laughter Yoga on Vasomotor Symptoms and Sleep Quality

The research was planned as a prospective, randomized controlled experimental study to determine the effect of online laughter yoga applied to menopausal women on vasomotor symptoms (VMS) and sleep quality. Research Hypotheses ar below; H0: Online laughter yoga has no effect on VMS. H1: Online laughter yoga has an effect on VMS. H0: Online laughter yoga has no effect on sleep quality. H1: Online laughter yoga has an effect on sleep quality.

The sample will consist of 82 menopausal women aged 40-60 years and experiencing at least one of the VMS. Intervention group: Online laughter yoga will be applied to women by a researcher who has an internationally approved certificate. The intervention group will receive eight online laughter yoga sessions, two sessions per week for four weeks. In this study, the number of laughter yoga sessions was determined in line with the studies in the literature. Each laughter yoga session is planned to last approximately 40-45 minutes. Each session of laughter yoga consists of clapping and warm-up exercises, deep breathing exercises, childlike play and laughter.

No intervention will be applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* - enrolled in the Menopause School,
* Signing the Informed Consent Form,
* Willing to participate in the research,
* Able to read and write Turkish,
* Open to communication,
* Those who are between the ages of 40-60 and have not experienced menstruation for at least one year,
* Experiencing at least one of the vasomotor symptoms
* A VMS severity of at least 4 according to the Visual Analog Scale,
* Not using drugs for the treatment of vasomotor symptoms,
* No chronic disease
* Regular laughter yoga is not practiced,
* Those who have not entered the menopause surgically,
* Women without psychiatric problems

Exclusion Criteria:

* - Not enrolled in Menopause School,
* Not signing the Informed Consent Form,
* Not willing to participate in the research,
* Cannot read and write Turkish,
* Unable to communicate
* Less than 40 years old, over 60 years old, experienced menstruation for at least one year,
* Not experiencing vasomotor symptoms,
* VMS severity is less than 4 according to the Visual Analog Scale,
* Using drugs for the treatment of vasomotor symptoms,
* Having a chronic disease,
* Regular laughter yoga practice
* Those who have surgically entered the menopause,
* Women with psychiatric problems
Efficacy and Safety of Lambdalina (Lidocaine Cream) Versus Placebo as an Anesthetic for Laser Hair Removal

Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.


Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 and ≤ 65 years old.
2. Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
3. Able of accomplishing the study's requirements.
4. Negative result in the pregnancy test.
5. Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
6. Written informed consent prior to inclusion in the trial.

Exclusion Criteria:

- General exclusion criteria:

1. Pregnant or breastfeeding.

   - Current or previous medical conditions:
2. Skin type 5 or 6 or a history of photosensitivity.
3. Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
4. Neuropathy or paresthesia.
5. History of hepatic failure.
6. Autoimmune diseases.
7. Allergies to peanuts and/or soy and/or any components of the formulation.
8. Use or dependence on prohibited substances.
9. Other contraindications specified in the summary of product characteristics.

   - Current or previous concomitant medications:
10. Any anesthetic or analgesic treatment during 2 hours prior of study entry.
11. Concomitant treatment with antiarrhythmic drugs of class I (eg. tocainide, mexiletine) or class III (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers.
12. Active wounds or irritations in the area to be treated.
13. Topical treatment with corticosteroids or other topical agent in the area to be studied.
Effect of Blueberries on Bone Turnover

This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a 42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce calcium loss from bones.

Participants will be dosed with Ca-41, a rare long-lived radioisotope of calcium. After the equilibration of tracer in the body and its deposition in bones (150 days), subjects will be randomized to one of 6 dose sequences, all of which will begin with a 42-day baseline period. During baseline, 24-hour urine will be collected every 14 days. Following baseline, subjects will enter a 42-day intervention period with one of three doses of blueberries equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of blueberries per day. Each dose will be provided in the form of freeze-dried blueberry powder incorporated in 2-4 foods or beverages per day. During the intervention, 24-hour urine will be collected weekly for 6 weeks except week 1. After intervention, subjects will enter a 42-day washout period, during which 24-hour urine will be collected every 3 weeks. The entire study duration will be 444 days for subjects who have not been dosed with Ca-41 previously. In a crossover design, all subjects will complete three 42-day intervention periods corresponding to the three doses of blueberries (low, medium, and high), each followed by a 42-day washout period. The dose-response effect of continuous blueberry consumption over a 42-day period on bone resorption in healthy post-menopausal women will be studied by measuring the loss of Ca-41 in urine by Accelerator Mass Spectrometry.

Eligibility Criteria:
Inclusion Criteria:

* Female subject is healthy
* Subject is \> 4 years past the onset of natural menopause or total hysterectomy

Exclusion Criteria:

* History of metabolic bone disease or low trauma fractures;
* Subject taking osteoporosis treatment drugs or glucocorticoids within 6 months of the beginning of the study;
* Subjects taking bisphosphonates within 2 years of the beginning of the study;
* History of cancer, thromboembolisms, clotting disorders, uncontrolled hypertension, abnormal thyroid function, malabsorption syndrome, seizure disorders, or heart attack;
* BMI \> 35 kg/m2;
* Subjects who will not comply with study interventions ;
* Subjects who will not stop taking natural product supplements of their own selection.
Pretreatment to Reduce Pain and Discomfort During Fiberoptic Nasal Pharyngoscopy and Laryngoscopy

Fiberoptic laryngoscopy (FOL) is one of the most common procedure done in an Ear Nose Throat (ENT) clinic. Topical anesthesia or decongestant or both have been used to improve patient comfort level during the procedure. Recently, role of these agents has been questioned. The investigators would like to study whether topical anesthesia or decongestant or their combination provide any benefit to the patients undergoing FOL.

Patient undergoing Fiberoptic laryngoscopy (FOL) will be randomized into four groups by block randomization. Group one will receive atomized spray of normal saline as placebo before the procedure. Group two will receive two sprays of atomized oxymetazoline (approx 0.18 ml of 0.05% oxymetazoline) with a gap of 10 seconds in between the sprays. Group three will receive two sprays of 15% lidocaine with a gap of 10 seconds in between the sprays. Group four will receive two sprays of oxymetazoline and then two sprays of lidocaine at an interval of two minutes.

Sample size calculation: With alpha error of 0.05, power of .8, mean discomfort scale for placebo of 2.8 (literature review) and SD of 1.1, presuming that the treatment would be able to reduce discomfort by at least 25%, with two tailed test and same SD, minimum sample size would be 40 in each group.

To reduce bias, all the procedure will be performed by senior consultants. Patients and the person performing the procedure will be blinded.

Discomfort of pre-medication, discomfort of scope insertion, pain due to scope insertion, and ease of procedure will be scored as VAS score (1 to 10, 1 is least and 10 is most). Also, patient will be asked how likely s/he is to recommend the similar procedure to his/her friends and family members in case they need to undergo the same. Side effects of pre-medication and procedure will also be noted.

Outcome variables among the groups will be compared using ANOVA test if they are normally distributed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing fiberoptic naso pharyngo laryngoscopy in OPD setting
* Consent to study
* above 18 years

Exclusion Criteria:

* gross nasal mass
* pregnants
* known hypersensitivity to the drugs used for premedication
* who cannot respond to questionnaire during data collection