cyrilzakka/clinical-trials huggingface dataset:
Improving Psychological Well-being of Trainee Civil Servants in Pakistan

Political and civil instability in Pakistan has placed many segments of society under stress. A 5-session group intervention incorporating principles of stress management, problem solving, behavioural activation, peer-support and adaptive leadership has been developed and successfully piloted for business professionals working under stressful conditions in Pakistan. The aim of this study is to evaluate the effectiveness of an adapted version of the intervention in improving psychological well-being amongst a group of trainee civil servants in the country.

A two-arm single blind, randomised controlled trial of the group intervention will be conducted among trainee civil servants in Pakistan. The participants are newly inducted civil servants (n=240) undergoing a 6 months' induction training. The participants will be randomised on a 1:1 allocation ratio (120 in each arm), with the intervention arm receiving the group intervention integrated into their orientation sessions and the control arm receiving orientation sessions alone. Outcome assessments will be conducted immediately post-intervention and 3 months after the completion of the intervention. The primary outcomes will be change in the prevalence of psychological distress as measured by Patient Health Questionnaire-9 (PHQ-9) and improvement in coping strategies as measured by Brief Cope Questionnaire. Secondary outcomes include symptoms of anxiety (measured by Generalized Anxiety Disorder scale (GAD-7)), well-being (measured by WHO5 well-being index) and psychological capital (measured by Psychological Capital Questionnaire).

The primary analyses will be intent-to-treat consisting of all participants included, according to the groups in which they will be randomized. The primary analysis will involve comparing pre to post changes in prevalence of psychological distress and coping strategies of the participants randomly assigned to the two conditions, using Fisher's exact test. Primary analyses will be non-parametric tests; however sensitivity analyses will use parametric models such as linear and logistic regression to control for baseline values of the participants' characteristics.

Ethical principles of voluntary informed consent, maintaining anonymity and confidentiality, data management and storage will be followed.


Eligibility Criteria:
Inclusion Criteria:

* All newly inducted civil servants attending the CTP at the CSA, Lahore, which is a six months residential training course, and
* who give informed voluntary consent to take part in the study.

Exclusion Criteria:

* Participants having a physical health condition that does not allow them to attend the sessions will be excluded.
Validation of a Lung Inflammation Model in Healthy Volunteers by Radiological Tools and Glucocorticoid Treatment

The purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (LPS) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model.

The investigators will also explore whether glucocorticoid treatment can blunt LPS effects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities. (Trial activities are any procedure that would not have been performed during normal management of the subject).
* Nonsmoker
* Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* If female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method)
* Negative urine pregnancy test

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Pregnancy or Lactation
* Treatment with an investigational drug within three weeks prior to this trial
* Participation in an LPS trial within the last 6 weeks
* Smoking
* History of relevant cardiac arrhythmia
* Preexisting open or closed angle glaucoma
* History of Osteoporosis, Cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery
* Systemic tuberculosis
* Hemorrhagic diathesis
* Relevant liver or kidney dysfunction
* Regular use of medication or abuse of alcohol unless considered clinically relevant
* Use of any medication within one week prior to the first trial day
* Symptoms of a clinically relevant illness in the 3 weeks before the first trial day
* Excessive sporting activities
* Rosacea
* Subjects on Monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate)
* Known acute or active hepatic disease within the past 3 months
* A platelet count \< 100,000 x 106/L, prothrombin time \> 1.5, liver enzymes\> 3 times the upper normal limit
* Having received a vaccination up to 8 weeks before the trial
Rio Trial - ReoPro and Peripheral Arterial Intervention to Improve Clinical Outcome in Patients With Peripheral Arterial Disease

The Rio Study is a randomized, double blinded German- Swiss- Austria multi-centre trial on the efficacy and safety of ReoPro together with interventional recanalization of TASC D lesions in the SFA and popliteal artery.

Purpose: The RIO trial is designed to test the efficacy of GP IIb/IIIa blockade on subacute reocclusions in patients with interventional recanalization of chronic occlusions in the superficial femoral and popliteal artery.

Methods: A total of 420 patients will be randomly assigned to ReoPro or placebo. Patients will be eligible for randomisation with occlusions longer than 5 cm. Doppler ultrasound follow-up will be at 30 days, and after 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of peripheral artery disease with superficial femoral or popliteal artery occlusion, which mandates PTA or stent administration as first treatment modality. The history of peripheral artery occlusion has to be at least 6 weeks, and the target vessel occlusion has to be more than 5 centimeters in length.
* Age between 18 and 90 years

Exclusion Criteria:

* Acute limb ischemia
* Subacute ischemia with requires thrombolysis as first treatment modality
* Active bleeding or known bleeding diathesis
* Known severe hepatic or renal disorder (liver cirrhosis, stage B, C or serum creatinine \> 2.5 mg%)
* Hyperthyreosis
* Diabetes mellitus treated with metformin
* Known heparin induced thrombocytopenia (HIT, type 2)
* Female sex with childbearing potential
* Major surgery or trauma in past 6 weeks
* History of stroke within the previous 2 years, or any stroke with a residual neurological deficit, or other CNS abnormality (e.g., intracranial neoplasm, arteriovenous malformation, or aneurysm)
* Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks
* Administration of oral anticoagulants within the previous 7 days unless prothrombin time is \< 1.2 times control (or international normalized ratio \[INR\] \<1.4), or ongoing treatment with oral anticoagulants
* History of bleeding diathesis of platelet count \< 100,000/mm3
* Arteriovenous malformations or aneurysms
* Severe uncontrolled hypertension (treated sys. BP \> 200 mm Hg, diast. BP \> 100 mm Hg)
* Hypertensive or diabetic retinopathy
* Vasculitis
* Known autoimmune disorders
* Patient with aspirin intolerance
* Contraindication or known allergic reactions to abciximab or murine proteins
* Co-existent condition associated with a limited life expectancy (e.g., advanced cancer, end-stage congestive heart failure)
* Participation in another clinical research study involving the evaluation of another investigational drug or device within 7 days prior to enrollment
* Patient who has previously received a GP IIb/IIIa antagonist
A Quality Ensuring Project With Focus On Patients With Cardiovascular Diseases As Well As Type 2 Diabetes.

The overall objective is to increase the adherence to national guidelines for patients with established CVD and/or Type 2 diabetes by means of repeated post-graduate educational meetings and regular evaluation of the optimisation initiatives, demonstrated by improvement of goal attainment in general practice.


Eligibility Criteria:
Inclusion Criteria:

* Subjects had to meet all of the inclusion criteria to be eligible for enrollment into the study. The following subjects qualify for inclusion in the study:
* Subjects for whom measurement of total cholesterol, low density lipoprotein (LDL) cholesterol, blood pressure (BP) and glycosylated hemoglobin (HbA1c) was planned independently of this observational study and for whom baseline values were or became available.
* Subjects with known CVD diagnosed \> or = 6 months before inclusion
* Previous myocardial infarction
* Ischemic heart disease (stable and unstable angina pectoris)
* Ischemic apoplexy
* Peripheral arterial disease
* And/Or
* Subjects with T2D diagnosed \> or = 6 months before inclusion
* At least 50% of the subjects had to have CVD as the primary diagnosis. It was allowed for a secondary diagnosis to be \<6 months before inclusion.

Exclusion Criteria:

* Subjects presenting with any of the following were not to be included in the study:
* Life expectancy of \< or = 2 years
* Unable/unwilling to understand/follow instructions
* Taking part in a clinical study involving an investigational drug
* Followed by a specialist for their CVD and/or T2D at the time of inclusion in the study
The "Global Paradise System" Registry

The GPS Registry is a multi-centre, single-arm, non-interventional (observational) registry. In addition to collecting data from patients treated as per standard clinical practice, the Registry will also regularly collect telemetric Home Blood Pressure (HBP) measurements and Patient Reported Outcome (PRO) data via a standardized quality of life questionnaire. The objective of the GPS Registry is to document the long-term safety and effectiveness of the commercially available Paradise Ultrasound Renal Denervation System when used per its labelling in patients deemed to be candidates for RDN as per physician's assessment.


Eligibility Criteria:
Inclusion Criteria:

* Appropriately signed and dated informed consent
* Age ≥18 at time of consent
* Patient candidate for renal denervation with the Paradise System based on physician's assessment OR Patient treated with the Paradise Ultrasound Renal Denervation System within the 6 months prior to consent

Exclusion Criteria:

Patients who meet any of the contraindications listed in the Instructions for Use will be excluded.

The contraindications are:

* Stented renal artery
* Less than 18 years of age
* Pregnant
* Known allergy to contrast medium
* Renal arteries diameter \< 3 mm and \> 8 mm
* Renal artery with Fibromuscular (FMD) disease
* Renal artery aneurysm
* Renal artery stenosis of any origin \>30%
* Iliac/femoral artery stenosis precluding insertion of the Paradise catheter
Strategy-confirming Study of BMS-955176 to Treat HIV-1 Infected Treatment-experienced Adults

The purpose of this study is to evaluate whether the combination of BMS-955176 with atazanavir (ATV) \[with or without ritonavir (RTV)\] and dolutegravir (DTG) is efficacious, safe, and well-tolerated in HIV-1 infected treatment experienced adults.


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women, at least 18 years of age
* Antiretroviral treatment-experienced, defined as having documented evidence of having failed 1 or 2 regimens that include 2 or 3 classes of antiretroviral (ARV) (with or without documented resistance)
* CD4+ T-cell count \> 50 cells/mm3
* Screening genotype/phenotype indicating susceptibility to study drugs (unboosted ATV, FC \< 2.2; DTG; TDF)

Exclusion Criteria:

* Antiretroviral treatment-experienced adults who have failed \> 2 ARV regimens
* Resistance or partial resistance to any study drug determined by tests at Screening
* Historical or documented genotypic and/or phenotypic drug resistance testing showing certain resistance mutations to ATV, TDF, RAL, Protease Inhibitors, and certain TAMs
* Chronic hepatitis B virus (HBV)/ hepatitis C virus (HCV)
* Blood tests that indicate normal liver function
* Hemoglobin \< 8.0 g/dL, Platelets \< 50,000 cells/mm3
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Prospective, open label, single-arm, non-randomized, multi-center study designed to evaluate the efficacy, safety and tolerability of the Renew Insert in moderate-to-severe bowel incontinence patients: Minimum Wexner score of 12 AND at least weekly (score 3 or higher) leakage of solid and or liquid type stool.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Minimum Wexner Bowel incontinence score of 12 AND at least weekly (score of 3 or higher) leakage of solid and/or liquid type stool, with no greater than 50% of subjects with daily (score 4) of uncontrolled gas.
* Patients colon surveillance must be in compliance with American Cancer Society colon screening guidelines. If patient is out of compliance, they may be scheduled for Colonoscopy.
* Patient comprehends study meaning \& is capable of carrying out study duties
* Fluent in English

Exclusion Criteria:

* American Society of Anesthesiologist (ASA) score of 4 or higher
* Spinal cord injury or other major neurological diagnosis
* Known immune deficiency state
* Significant cardiac arrhythmia
* Pregnant or Breastfeeding
* Inflammatory bowel disease
* Requirement of medication delivered by suppository
* Active perianal abscess or fistula
* Present rectal prolapse
* Third degree hemorrhoids
* Anal stricture
* History or rectal spasm
* Rectal surgery in past 6 months
* Unresolved Anismus
* Fecal impaction with overflow diarrhea
* Ileo-anal pouch
* Rectocele requiring surgery
* Allergy to silicone or one of its components
* Significant medical condition which interferes with study participation
Ergocalciferol in Chronic Kidney Disease

To examine the effect of ergocalciferol treatment on 25-hydroxyvitamin D and PTH levels in patients with CKD stage 3 and 4


Eligibility Criteria:
Inclusion Criteria:

* Patient with CKD stage 3 or 4 whose 25-hydroxyvitamin D levels are below 30 ng/ml and plasma intact PTH levels \>70 pg/ml.

Exclusion Criteria:

* Patients who are on any form of active vitamin treatment
Ultrasound-guided Femoral Nerve Block Without Electrical Stimulation of Peripheral Nerves

There is little work comparing the effectiveness of a femoral nerve block performed only under US guidance or US plus electrical stimulation of the peripheral nerve (EPN). The authors have shown the same effectiveness of these techniques(1).But the effectiveness of the blockade of the femoral nerve (complete blockade) performed in different ways turned out to be low valve: 71.7% for ultrasound in combination with electrical stimulation versus 69% for only ultrasound guidance.

Research hypothesis: the blockade of the femoral nerve performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.


Eligibility Criteria:
Inclusion Criteria:

* indication requiring anesthesia maintenance;
* patient's written consent about the type of anesthesia and possible complications of regional anesthesia

Exclusion Criteria:

* patient's refusal of application for the proposed form of anesthesia;
* patients younger than 18 years;
* patients weighing less than 50 kg;
* a physical status score of more than 3 determined by the American Society of Anesthesiologists (ASA);
* a history of allergic reactions to the drugs used;
* coagulopathies;
* infections of the skin at the injection site;
* neurological or neuromuscular diseases;
* severe liver diseases or kidney failures;
* an inability to cooperate with the patient.
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fed conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any comparable or similar product.
Evaluation of Melatonin's Effect on Pain and Blood Loss After Cesarean Section

The purpose of this study is to assess the effect of melatonin on pain and amount of blood loss after cesarean delivery one hundred twenty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 40 each to receive sublingual 3 mg melatonin or 6 mg melatonin or placebo before spinal of anesthesia . In all patients 20 IU syntocinon which dissolved in 0.5liter of lactated Ringer's solution) at the rate of 500 ml over a 15 minutes period, immediately after delivery of the neonate was infused . Time to first requirement of analgesic supplement, Hemodynamic variables,will be recorded.Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS \>4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given. For determination of blood loss ,change in hemoglobin levels, need for additional oxytocics and ,the volume of blood in the suction bottle was measured, blood soaked sponges. Hemoglobin values were determined both before surgery and 12 h following surgery


Eligibility Criteria:
Inclusion Criteria:

* pregnant women at term (37-40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

Exclusion Criteria:

* women with any risk factor associated with an increased risk of postpartum hemorrhage were excluded i.e. multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus
* current or previous history of significant disease including heart disease, liver, renal disorders ,anemia (Hb8 g%)or known coagulopathy
Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure

The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for excisional biopsy wounds closure

Excisional biopsy of the skin is a biopsy in which an entire lesion is removed. An excisional biopsy is in contrast to an incisional biopsy in which only a sample of tissue is cut into and removed. It is most frequently done to diagnose a skin growth such as a mole, or cancer of the skin.

The most common method of wound closure of skin excisions is interrupted nonabsorbable sutures. The sutures should be removed as soon as adequate intrinsic bonding strength is sufficient, depending mostly on the specific body region (from 5-7 days for the face and up to 12-14 days for trunk and extremities).

Laser energy, also known as laser welding, has been used on limited basis as an alternative to traditional wound closure method. There have been two fundamental approaches to laser assisted bonding of tissues:

1. Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
2. Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).

Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).

Eligibility Criteria:
Inclusion Criteria:

1. Male/Female age 18-60.
2. Subject is scheduled for excisional biopsy surgery.
3. Subject able to comprehend and give informed consent for participation in this study.
4. Signed informed consent form.

Exclusion Criteria:

1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
2. Acute infection requiring intravenous antibiotics at the time of screening.
3. Bleeding, coagulation and or clotting disorders.
4. Diabetes mellitus: IDDM or NIDDM.
5. HIV positive or any other immunosuppressive disorder.
6. Renal failure (Serum creatinine \>2.0 mg/dl).
7. Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
8. Any concomitant infection - viral or bacterial.
9. Drug abuse.
10. Use of steroids.
11. Infection / abscess / pain in treatment target area.
12. Pregnancy or lactating.
13. History of keloid scarring.
14. Use of aspirin or antioxidants
15. Subject is suffering extreme general weakness.
16. Subject objects to the study protocol.
17. Known cognitive or psychiatric disorder
18. Concurrent participation in any other clinical study.
19. Physician objection.
Comparison of Intrathecal Fentanyl or Sufentanil in 1 mg Bupivacaine Spinal Anesthesia for TURP in Elderly Patients

Adequate sensory block for surgical procedure without side effects and immediate mobilization after surgery are desirable anesthetic technique in various surgeries. Considering the sensory innervations to the prostate, a sensory block up to L1 - T12 is adequate to the TURP. Low-dose intrathecal local anesthetics may meet these criteria, but occasional lack of sufficient sensory block could be troublesome. In this randomized study, the investigators evaluated the spinal anesthetic characteristics following intrathecal administration of bupivacaine 1 mg with fentanyl or sufentanil in elderly patients undergoing TURP.


Eligibility Criteria:
Inclusion Criteria:

* age over 65 \~ under 85yrears old
* male
* elderly patients undergoing TURP
* only spinal anesthesia
* patients consent about this study

Exclusion Criteria:

* spine surgery History
* coagulopathy
* impaired communication
* impaired orientation
* DM complication neuropathy
* BMI \> 30 -\> overweight patients.