cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant females at least 18 years of age with HSV-2 seropositive serology with or without history of clinically diagnosed recurrent genital herpes

Exclusion Criteria:

* Pregnancy
* History of renal dysfunction
* Use of immunosuppressive therapy, including steroids (other than topical or inhaled), or use of probenecid
* Hypersensitivity to famciclovir, valacyclovir or drugs with similar chemical structure
Mechanical Versus Manual Chest Compression

In this study, the investigators compared mechanical and manual chest compressions in out-of-hospital cardiac arrest cases.

In this study, the investigators retrospectively analyzed resuscitations performed over a 2-year period and compared manual and mechanical chest compressions in terms of return of spontaneous circulation, 30-day survival, and hospital discharge parameters.

Eligibility Criteria:
Inclusion Criteria:

Over 18 age Cardiac arrest cases Out-of-hospital arrest

Exclusion Criteria:

\<18 age
Comparison of Myoinositol and Metformin in PCO

Aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.

The secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study.

It will be a Three-arm prospective double-blind study. this clinical trial will be registered in Public registry. this RCT will be based on CONSORT statement. The patient coming to Gynecology OPD will be randomized into 3 groups GROUP A ( metformin 500 mg TDS), GROUP B( myoinositol 2mg x BD ), GROUP C.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.

PCOS is a common endocrine disorder in women of reproductive age associated with insulin resistance. Metformin and Myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with PCOS or having oligo/amenorrhea, reduction in weight and BMI, Improvement in the biochemical and clinical profile of patients with the polycystic syndrome.

Inclusion criteria: will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.

Patients with history of Hyperprolactinemia, Cushing's disease, Hypothyroidism/ Hyperthyroidism, Pregnancy and nursing, Established type 1 or type 2 diabetes mellitus, Any history of drug intake e.g. anti-diabetic or estrogen and progesterone, History of treatment for the same complaint taken in the last 3 months, Unable to come for regular follow-ups, Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology and known allergic to these drugs would be excluded.

Eligibility Criteria:
Inclusion Criteria:

It will be based on the Rotterdam criteria of diagnosing PCO. Patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of PCO will be included in this group.

Exclusion Criteria:

* Hyperprolactinemia
* Cushing's disease
* Hypothyroidism/ Hyperthyroidism
* Pregnancy and nursing
* Established type 1 or type 2 diabetes mellitus
* Any history of drug intake e.g. anti-diabetic or estrogen and progesterone
* History of treatment for the same complaint taken in the last 3 months
* Unable to come for regular follow-ups
* Any pathological cause of bleeding e.g. Fibroid, Polyp, Cervical pathology
* Known allergic to these drugs
Efficacy of Cefepime Continuous Infusion Versus an Intermittent Dosing Regimen

To determine the efficacy of the administration of 7 to 14 days of cefepime in a continuous infusion vs an intermittent (every 8 hours) administration, in adult patients hospitalized in Bogotá with sepsis and bacteremia caused by gram negative bacilli. The outcome was the rate of clinical cure and microbiological cure after 7 and 14 days of initiation of therapy and rates of relapse after 28 days.

Hypothesis: The administration of beta lactams in continuous infusion allows a clinical or microbiological cure greater than the intermittent administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sepsis, severe sepsis o septic shock diagnosis hospitalized in Intensive care Unit.
* Presence or suspect of Gram negative bacilli bacteremia
* To be possible the follow up according to planned visits
* Patients should be venous access to administrate the antibiotic
* Patients, whom the physicians consider cefepime like election treatment

Exclusion Criteria:

* Patients with a high degree of immunosuppression defined by:

  * The presence of neutropenia (Neutrophils count less than 500 cells/mL, or Infection with HIV-AIDS with count of less than 50 CD4 cells/mL, or chronic Administration of immunosuppressive drugs (prednisone more than 5 mg/per day, azathioprine, cyclophosphamide, mycophenolate mofetil, etc.)
* Patients with chronic renal failure.
* Pregnant female patients
* Patients in whom to approach the doctor is considered with a high probability of dying in the next 48 hours (e.g. multiorgan system failure with more than 5 organs engaged according to the criteria of MarshalL et al. or shock irreversible.
* Patients with chronic infections as osteomyelitis or have prosthesis that would perpetuate the infection and requiring the administration of antibiotics for an extended time (including Endocarditis). -Patients with mixed infections that include Gram positive microorganisms or fungal infections.
* -Patients who have received in the past 30 days cefepime.
* Patients with presence of a gram negative bacillus resistant to cefepime. -Patients who are not able to identify them a bacillus gram negative.
* Patients who they are not able to confirm the antibiotic susceptibility of gram negative bacillus. -Patients with concomitant with antimicrobial activity for Gram negative bacilli (e.g. fluoroquinolones, aminoglycosides, etc.)
* Patients who have known hypersensitivity to B lactams or cefepime
Supplement Combination on Stress and Sleep

The purpose of this clinical trial is to assess the effects of a supplement combination on measures of sleep quality and stress in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants aged 18 to 50 years (inclusive) at the time of screening with a body mass index of 18.5 to 29.9 kg/m2.
* Willing to give voluntary consent, be able to understand and read the questionnaires, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow any study-related evaluations.
* Participant is physically active: participating in resistance and/or endurance exercise ≥150 min/wk for ≥6 mo.
* Participant will be asked about dietary supplementation use within the past 6 months.

If participant began taking a supplement within the past month, participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.In all other cases, supplement use will be asked to be maintained throughout the study.

• The participant has an apple device with iOS 16 or greater software.

Exclusion Criteria:

* Have a known sensitivity of allergy to any of the investigational products.
* Participants currently taking any of the investigational products will be excluded.
* Female participants who are lactating, pregnant, or planning to become pregnant during the study.
* Diagnosed with any sleep-related or stress-related disorders.
* Currently taking medication to manage sleep or cortisol levels.
* Participants with controlled or uncontrolled hypertension including stage 1 hypertension (systolic blood pressure ≥129 mmHg and diastolic blood pressure ≥89 mmHg).
* Any other condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.
Multi-Centre, Observational Study on Safety of Bevacizumab Biosimilars in Clinical Practice Among Chinese Patients

Monoclonal antibody drugs are expensive, and the listing of biosimilar drugs can help increase the availability and lower prices of biologic drugs, and can better meet the public's demand for biotherapeutic products. The first bevacizumab biosimilar in China was launched in December 2019. Although monoclonal antibody biosimilar drugs are similar to the original drug in terms of quality, safety and effectiveness, their production process may be different from the original drug, and their clinical application cannot be completely equivalent to the original drug. Especially after the market is applied to a wider patient population, the safety and effectiveness are more worthy of attention. This study started from the perspective of pharmacy. Three hospitals in China participated in the real-world safety assessment of bevacizumab biosimilars. An observational cohort study design was adopted to include all cases of lung cancer and colorectal cancer using bevacizumab biosimilars and original drugs during the study period, and the propensity score matching was used to reduce the influence of confounding factors and conduct safety assessment.


Eligibility Criteria:
Inclusion Criteria:

* ①Inpatients diagnosed with non-small cell lung cancer or colorectal cancer; ②Bevacizumab biosimilars or original drugs were used for treatment during the study period.

Exclusion Criteria:

* ①Age\<18 years old; ②Person who has used bevacizumab within six months.
Effects of Travoprost on Neovascular Glaucoma

Prostaglandin analogues have not been used in the treatment of neovascular glaucoma because of suspicious lack of efficacy. This study aims at assessing the effect of travoprost on neovascular glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* Neovascular glaucoma of known cause
* Older than 18 years
* Previously submitted to retinal photocoagulation
* Under medical treatment to glaucoma

Exclusion Criteria:

* Need of antiglaucomatous surgery
* Previous ocular surgery in the last 6 months
* Pregnancy
L-arginine and Vitamin D Adjunctive Therapy in Pulmonary Tuberculosis (TB)

The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can improve response to standard short course TB therapy in people with newly diagnosed pulmonary TB.

The two major pathways proposed to mediate macrophage mycobacterial killing in humans are the arginine-nitric oxide and Vitamin D-1,25 dihydroxyvitamin D pathways. Our aim is to determine if the key immunomodulatory agents L-arginine and vitamin D can improve the rapidity and magnitude of the microbiological and clinical response in pulmonary TB. We will test the following hypotheses in newly-diagnosed TB patients in Timika, Papua, Indonesia:

Our specific aims are to:

1. Determine whether supplementation with L-arginine and/or vitamin D is safe, and results in more rapid improvement in clinical, mycobacterial, immunological, radiological, physiological and functional measures of treatment outcome. We will randomise patients with pulmonary TB to receive, in addition to standard TB therapy, adjunctive arginine, vitamin D and / or placebo in a randomised, double-blind factorial 2x2 design. We will relate serial measurements of plasma concentrations of L-arginine and vitamin D, and immunological responses (pulmonary NO production, T cell function and phenotype) to measures of treatment outcome \[mycobacterial (sputum smear clearance and culture conversion), physiological (spirometry), clinical (symptoms and weight), radiological (chest Xray) and functional (six-minute walk test, modified St George Respiratory Questionnaire)\].
2. Determine whether pulmonary production of NO is inversely related to disease severity at presentation. Baseline and serial measures of NO production will be related to disease severity and the magnitude and rapidity of clinical response

Eligibility Criteria:
Inclusion Criteria:

* Adults \>15 years with sputum smear positive pulmonary TB
* New cases only
* Agree to continue treatment in Timika for the full six month course of treatment -Not pregnant
* Consent to enroll in the study.

Exclusion Criteria:

* hypercalcaemia (ionized calcium \>1.32 mmol/L) identified at baseline
* taking arginine or vitamin D
Respiratory Training Intervention

This study aims to examine the effect of abdominal diaphragmatic breathing combined with incentive spirometer breathing training on the lung capacity of elderly community residents.

The research will be conducted in a community in central Taiwan. Inclusion criteria are people over the age of 65 in the community. All participants will be randomly assigned to either the experimental group or the control group. The experimental group will receive the breathing training of abdominal diaphragmatic breathing method combined with incentive spiromete. The control group is only taught the breathing training of abdominal diaphragmatic breathing. Four assessment tools will be used, including the demographic questionnaire, respiratory capacity indicators, Modified Medical Research Council (mMRC) Dyspnea Scale, and the World Health Organization Quality of Life-BREF Taiwan Version (WHOQOL-BREF; WHOQOL-BREF). Data analysis will be performed by independent sample t test, paired t test, and repeated measures analysis. All data analysis will be performed by SPSS version 22.0.

Eligibility Criteria:
Inclusion Criteria:

1. Over 65 years old
2. A person who is conscious and can communicate in Mandarin or Hokkien, and can cooperate with breathing exercises.
3. Agree to interview or fill out the questionnaire, and complete the consent form.

Exclusion Criteria:

1. Hemoptysis, pneumothorax, unstable cardiovascular status, chronic respiratory diseases (asthma, chronic obstructive pulmonary disease).
2. Recent myocardial infarction or pulmonary embolism, thoracic aortic aneurysm, abdominal aortic aneurysm or cerebral aneurysm, recent eye surgery, nausea or vomiting, recent chest or abdominal surgery.
3. Suffering from infectious diseases: airborne such as: chickenpox, measles, tuberculosis, severe special infectious pneumonia influenza. Droplet transmission such as: pneumonia, influenza.
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning in Patients With Type 1 Diabetes

Remote ischemic conditioning (RIC) is a therapeutic strategy for protecting organs or tissue against the detrimental effects of acute ischemia-reperfusion injury. It remains unknown whether this can be used in retinal ischemic diseases. The purpose of the present study is to examine if the autoregulation of retinal vessel diameters in diabetic patients change after remote ischemic conditioning and if the observations are different from what have been observed in normal persons.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1
* Diabetic retinopathy

Exclusion Criteria:

* Previous treatment for diabetic retinopathy
* Other ocular and systemic diseases requiring treatment
* Pregnancy or lactation
The Prognostic Value of Interim PET/CT After 2 Cycles of Chemotherapy in Predicting Progression of Non Hodgkins Lymphoma

A retrospective analysis will be performed regarding the usefulness of PET/CT performed following 2 cycle of chemotherapy in evaluation of progression, free survival and overall survival of patients with aggressive non Hodgkin Lymphoma.

Patients who were treated for aggressive non-Hodgkin lymphoma with adriamycin containing regimen, CHOP and High dose CHOP with or without rituximab were evaluated post 2 cycles of chemotherapy to rule out disease progression . Currently a retrospective evaluation of PET/CT as a predictive value for progression free survival and overall survival is evaluated

Eligibility Criteria:
Inclusion Criteria:

* aggressive non-Hodgkin lymphoma b cells
* age 18-70
* bilirubin less then 2
* creatinine less then 2
* Pet/CT performed post 2 cycles

Exclusion Criteria:

* no PET/CT post 2 cycles performed
* bilirubin \>2
* creatinine more then 2
* HIV positivity
Optimal Analgesia for Forefoot Surgery

A randomised trial comparing three analgesic strategies for patients undergoing forefoot surgery in a day-surgery setting.

Forefoot surgery, including Scarf-Akin osteotomy surgery for bunion correction, is moderately painful orthopaedic surgery, commonly performed as a day-case procedure. Admission for opiate analgesia constitutes a failure of management and financial disadvantage to the healthcare organisation. The investigators seek to establish which technique will result in the best analgesia out of ankle block, metatarsal block, or a combination of the two. As analgesia constitutes part of a return to function, an additional aim is to determine whether either of these approaches will result in an objective functional benefit to the participants.

The trial seeks to recruit 23 patients into either of 3 groups: Ankle + sham metatarsal; sham Ankle + metatarsal; Ankle + Metatarsal.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or female, aged 18 years or above.
* Diagnosed with 1st metatarsal pathology requiring surgical correction
* Participant meets the criteria for operative management in our day-surgery unit

Exclusion Criteria:

* Contraindication to general anaesthesia
* Diabetic neuropathy affecting lower limbs
* Peripheral neuropathy affecting lower limbs of any aetiology
* Revision surgery
* Lack of capacity to consent
Dexamethasone for Cardiac Surgery Trial

This is a multicenter, randomized, double-blind trial, comparing clinical outcomes after the administration of high-dose dexamethasone versus placebo in patients undergoing heart surgery with the use of cardiopulmonary bypass. The primary endpoint is the occurrence of major complications (including all-cause mortality, myocardial infarction, stroke, renal failure, and prolonged mechanical ventilation) in the first 30 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* All types of cardiac surgery in which cardiopulmonary bypass is used

Exclusion Criteria:

* Age under 18 years
* Life-expectancy \< 6 months
* Emergency operations
* Re-operations within the same admission
INVESTIGATION OF PERIPHERAL OXYGEN SATURATION VALUES MEASURED IN DIFFERENT BODY POSITIONS AND FINGERS IN HEALTHY YOUNG ADULT INDIVIDUALS

This study aims to examine peripheral oxygen saturation values measured in different body positions and fingers in healthy young adult individuals.

The research was planned in a quasi-experimental design. The research population consisted of students/healthy young adults studying at Bursa Uludağ University Faculty of Health Sciences between January 2024 and May 2024. The research sample consisted of a total of 200 volunteer individuals who met the research limitations.

The research data were collected using the Individual Introduction Form and Peripheral Oxygen Saturation Monitoring Form. A pulse oximeter was placed simultaneously on the index and middle fingers of each participant\&#39;s active hand while they were in an upright sitting position. After the pulse oximeter was placed on both fingers for one minute, stable values seen on its screen for at least three seconds were recorded. Then, the participants were placed in a supine position, and after a 10-minute rest, similar measurements were repeated with a pulse oximeter placed on the index and middle fingers of the active hand.


Eligibility Criteria:
Inclusion Criteria:

* participating voluntarily in the study
* being aged over 18 years
* not having any acute or chronic disease

Exclusion Criteria:

* being less than 18 years of age,
* having anemia,
* not wanting to participate in the study, or during the course of the research, wishing to withdraw from the study,
* having an oxygen saturation value of less than 90%,
* being unable to tolerate a 0° prone position (bradycardic).
Early Mobilisation After Surgery in Patients With Elbow Fracture-dislocation

The purpose with the study is to evalute if early mobilsation after surgery in patients vid elbow frakture-dislocation may lead to better armfunction and reduce common complications as stiffnes in the elbow. After surgery patients will be randomised to either early mobilisation (exercise treatment 3 Days after surgery) or ordinary treatment (plaster and exercise treatment 3 weeks after surgery).

In patients with elbow fracture in combinations with dislocation, surgery is often indicated. After surgery the ordinary standard praxis treatment is immobilisation in a plaster for 3 weeks. One common complication is "stiff elbow". Stiffness in the elbow may be due to "heterotopic ossification" which is the abnormal growth of bone in the non-skeletal tissues including muscles or tendons. There is a prospective study that have reported positive results with early mobilisation starting two days after surgery in these patients. However, randomised clinical trials are missing. Therefore our aim was to investigate if early mobilisation may increase elbow function (increased range of motion and decreased pain) and also reduce comlications as stiff elbow compared to ordinary treatment in these patients.

All patients operated with elbow fracture-dislocation at the University hospital in Linköping were asked if the wanted to participate in the study. They had thourough written and oral information about the study. If they agree to participate written informed consent was collected. After surgery patients were randomised to either early mobilisation or to ordinary treatment (standard praxis).

At baseline before surgery or directly after patients filled in some background vatiables such as gender, age social status medical treatment etc They also filled in some self-adminstrated outcome measure in purpuse to evalute upper extremity function and activity and health related quality of Life.

Follow ups with X ray and upper extremity function and activity were at 3 weeks 3 and 12 months with an independent observer.

In beteween these follow ups patient followed the treatment regime (ordinary or early exrecise treatment) and had support from a physiotherapist.

Eligibility Criteria:
Inclusion Criteria: Patients over 18 years with elbow fracture-dislocation being operated on.

-

Exclusion Criteria:

* ongoing cancer and earlier radiation therapy in the study arm
* neurological disease
* cervcialgia or disc herniation in the neck
* associated nerv or blodvessel injury
* dementia