cyrilzakka/clinical-trials huggingface dataset:
Effects of IMT ON Dyspnea, PF and Quality of Life in Patients With CABG

Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs).

Patients in the intervention group will receive treatment until discharge from hospital.

A randomized control trial in which two groups one is intervention and the other is controlled group .Patient in the Intervention group will be treated with routine pysical therapy, Inspiratory muscle training and early ambulation after surgery, whereas patients in the control group will be not be treated with these interventions and will rather undergo routine physical therapy (ankle pumps, hand pumps isometrics of upper and lower limbs).

Patients in the intervention group will receive treatment until discharge from hospital. On the day of discharge they will be assessed using 6 minute walk test, Borg rate of perceive exertion and health related quality of life scale. Data will be analyzed using SPSS 25.

Eligibility Criteria:
Inclusion Criteria:

* Both Gender patients
* Patients who agreed to participate
* Age: 35 to 55

Exclusion Criteria:

* Patients with history of Angioplasty or CABG
* Chronic Renal failure
* Cardiac arrhythmias
* History of stroke
* Unstable angina
Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor

During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities.

The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention .

Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.


Eligibility Criteria:
Inclusion Criteria:

* gestational age between 37 and 42 weeks
* singleton pregnancy
* live fetus
* cephalic presentation
* neonatal birth weight of 2500-4500 g
* parity between one and five
* maternal age \< 35 years
* vaginal birth

Exclusion Criteria:

* blood pressure ≥ 140/90mmHg
* placenta previa
* placental abruption
* a history of any bleeding during pregnancy
* a history of curettage
* cesarean section or any uterine scar
* a history of postpartum hemorrhage
* polyhydramnios
* signs or symptoms of maternal infection
* known uterine anomalies
* history of any drug use during labor
* abnormal placentation)
* coagulation defects
* instrumental deliveries
* hemoglobin concentration \< 8 g/dL
* history of anticoagulant drugs
* beta-mimetic medications during pregnancy
* prolongation of the first stage of labor \> 15 hours.
Study of the Absolute Oral Bioavailability of Dapagliflozin in Healthy Subjects

The purpose of this study is to estimate the absolute oral bioavailability of dapagliflozin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects (ages 18 to 45) as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
* Participation in a radiolabeled investigational study drug trial within 12 months prior to admission to the clinical facility
* Exposure to significant radiation within 12 months prior to admission to the clinical facility
Tolerance and Acceptability Evaluation AYMES ActaGain

To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To evaluate tolerance and acceptability of 'AYMES ActaGain' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'AYMES ActaGain' (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients.
* ≥ 18 years of age.
* Patients of the intended target group (e.g. MUST score ≥ 1, with or at risk of disease related malnutrition) with an anticipated period of nutritional support ≥ 4 weeks.
* Patient is able and willing to provide written informed consent.

Exclusion Criteria:

* Patients with medical or dietary contraindication to any feed ingredients.
* Patients requiring sole enteral tube feeding or parenteral nutrition.
* Patients with chronic renal disease requiring dialysis.
* Patients with liver failure.
* Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Patients assessed by a Speech and Language Therapist who require thickened fluids.
* Participation in any other studies that may interfere with this study.
Effects of Virtual Reality and Nature Sounds on Pain and Anxiety in Women Having Cesarean Section

This study will be conducted to determine the effects of virtual reality application on pain and anxiety in postpartum women after cesarean section. It will be applied to women who have had a cesarean section and who volunteered to participate in the study and were randomly assigned to intervention (n=40) and control (n=40) groups in a faculty hospital and a state hospital in Turkey. The use of virtual reality glasses will be taught to the postpartum women in the intervention group. After the initial mobilization, the postpartum women will be shown a nature view video with virtual reality glasses (VRG) accompanied by nature sounds for 20 minutes. The aim of this application is to enable women to watch nature images more effectively accompanied by nature sounds, thus allowing them to focus on the images and sounds, distract them, relax and remove them from the tension of the current environment. The application will be performed with the women in a semi-recumbent position and without sleeping. The same application will be applied to each woman and the glasses will be disinfected with Dermosept surface disinfectant, which provides cold sterilization, before the application. No application will be applied to the control group; only the general routine maintenance of the hospital will be performed. Data will be collected by the researcher through face-to-face interviews based on the statements of the women after cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* Being over 18 years of ageBeing able to read and write in Turkish
* Giving birth at term, having a single, live and healthy baby
* The baby being with the mother
* Having a healthy/risk-free pregnancy
* Having had spinal anesthesia.

Exclusion Criteria:

* Having a diagnosed psychiatric disease,
* Having a mental disability and communication problem,
* Having a vision or hearing problem,
* Developing complications during or after a cesarean section,
* Having any obstacles to postpartum mobilization.
Investigation of Anxiety, Depression and Physical Activity Level in Whirling Dervishes

Sema, which means "to listen/hear" in lexical meaning, is a special physical activity performed in the form of rotating in different positions rhythmically with music.During the sema activity, although it is similar to dance therapy due to the cyclical movements it contains, it can also be evaluated as a physical activity. With Sema music therapy accompanied by musical melodies, it is similar to meditation, as the ties with the world are cut off and the attempt is made to reach divine love. Various studies have shown that physical activity, music therapy, dance therapy, and meditation have positive effects on depression and anxiety in the literature. However, there is no scientific study in the literature investigating the effects of Sema activity, which includes all these approaches, on depression, anxiety and physical activity. In order to support the literature in this sense, this study was planned to examine the effects of Sema activity on physical activity level, depression and anxiety. Individuals between the ages of 18-60 who are registered in Konya Mevlana Cultural Center who have been doing Sema for at least 1 year will be included in the study. Participants who agree to participate in the study will be asked to fill in the online Informed Volunteer Form, Demographic Information Form, Beck Anxiete Scale, Beck Depression Scale and International Physical Activity Scale - Short Form. The data will be analyzed statistically with SPSS version 23.0.


Eligibility Criteria:
Inclusion Criteria:

* Being literate
* Between the ages of 18-60
* Performing Sema for at least 1 year
* Doing sema regularly (at least 3 times a week)

Exclusion Criteria:

* Being diagnosed with depression
* Having any psychiatric illness
* Presence of chronic disease (hypertension, diabetes, neurological diseases, cancer etc.)
A Bioavailability and Safety Study of Probuphine Versus Sublingual Buprenorphine in Patients With Opioid Dependence

This study will measure the amount of buprenorphine found in the blood after taking sublingual buprenorphine tablets versus after implantation with 4 Probuphine (buprenorphine implants).

This is an open-label study intended to evaluate the relative bioavailability of 4 Probuphine implants versus 16mg QD sublingual buprenorphine, as determined by plasma BPN AUC(0-24), during 24 hours at steady state. This study will also provide open-label safety and tolerability data in patients treated with Probuphine.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent prior to the conduct of any study related procedures
* Male or female, 18-75 years of age
* Meet the DSM-IV criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception

Exclusion Criteria:

* Current diagnosis of Acquired Immune Deficiency Syndrome (AIDS)
* Received treatment for opioid dependence (e.g., methadone, BPN) within the previous 90 days
* Current diagnosis of chronic pain requiring opioids for treatment
* Candidates for only short term opioid treatment or opioid detoxification therapy
* Pregnant or lactating females
* Previous hypersensitivity or allergy to BPN or EVA-containing substances or naloxone
* Current use of agents metabolized through Cytochrome P450 3A4 (CYP 3A4) such as azole antifungals (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir, indinavir, and saquinavir)
* Current history of coagulopathy, and/or anti-coagulant therapy (such as warfarin)
* Meet the DSM-IV criteria for current dependence on any other psychoactive substances other than opioids or nicotine (e.g., alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed use
* Significant medical or psychiatric symptoms, cognitive impairment, or other factors which in the opinion of the Investigators would preclude compliance with the protocol, patient safety, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in study; and/or any pending legal action that could prohibit participation and/or compliance in study
* Participated in a clinical study within the previous 8 weeks
* Previous participation in a Probuphine clinical trial
* Presence of aspartate aminotransferase (AST) levels greater than or equal to 3 X upper limit of normal and/or alanine aminotransferase (ALT) levels greater than or equal to 3 X upper limit of normal and/or total bilirubin greater than or equal to 1.5 X upper limit of normal and/or creatinine greater than or equal to 1.5 X upper limit of normal
* Clinically significant low platelet count with current history of coagulopathy
Neural Mechanisms of Change During the Treatment of Alcohol Use Disorders With Prazosin

The study uses neurobiological measures through brain imaging, neuropsychological measures, and selfreport measures to try to understand how an effective treatment for alcoholism works. On the whole, less than 50% of people with alcoholism get better with treatment. This study will help researchers develop better treatments for alcoholism because if the investigators know why the treatments the investigators use are working, and in whom the treatments work best, then the investigators may be able to make treatment more effective by targeting treatments to individuals who would be most likely to benefit and by guiding development of more effective treatments in the future.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;
2. seeking but not currently receiving treatment;
3. able to provide voluntary informed consent;
4. have at least 4 drinking days in the past 30 days
5. english-speaking
6. have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.

Exclusion Criteria:

1. severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP\<110, SBP\>160, DBP\>110, HR\<55, HR\>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention;
2. schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;
3. current dependence on another drug of abuse (except nicotine);
4. contraindications to MRI (e.g., pacemaker);
5. active legal problems with the potential to result in incarceration;
6. pregnancy or lactation, or child bearing age and not on birth control;
7. currently receiving treatment for alcohol dependence;
8. current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;
9. history of seizures or DT's during alcohol withdrawal.
Crystalline Glucosamine Sulfate Therapy in Hand Osteoarthritis

The objective of this study is to retrospectively evaluate the symptomatic effects of crystalline glucosamine sulfate (GS), prescribed for the actually approved indication of knee OA, in addition to conventional therapy, in comparison to the conventional therapy alone in patients with primary hand osteoarthritis (HOA).This is a 6-months retrospective comparative study including patients with concomitant knee and primary HOA, according to the ACR criteria. To be eligible the patients had to present clinical symptoms of hand OA for at least 3 months, defined as global hand pain score superior to 40 mm on a 0-100 Visual Analogue Scale (VAS) and a Functional Index for Hand Osteoarthritis (FIHOA) score of at least 6. Furthermore, the patients have had a radiographic evidence of HOA within the previous 6 months with a Kellgren-Lawrence score of II-III. The participants are stratified into two groups based on whether or not crystalline GS at the daily dose of 1500 mg was added to the conventional therapy for HOA, including exercise, acetaminophen and non steroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase (COX)-2 inhibitors. Primary outcome measures are the difference between the two groups in the change of VAS pain and in the FIHOA, from baseline after 6 months. Secondary outcomes were health assessment questionnaire (HAQ), medical outcomes study 36-item short form (SF-36) and symptomatic drugs consumption.


Eligibility Criteria:
Inclusion Criteria:

* Mono or bilateral primary HOA and concomitant knee OA, according to the American College of Rheumatology (ACR) criteria
* Treatment for at least 6 consecutive months with crystalline GS at the daily dose of 1500 mg in addition to the conventional therapy or with usual care alone.
* HOA symptoms duration for at least 3 months defined as global hand pain score superior to 40 mm on a 0-100 VAS and a FIHOA score of at least 6.
* Radiographic evidence of HOA within the previous 6 months with a radiological score of II-III (using the Kellgren method).

Exclusion Criteria:

* Erosive Osteoarthritis of the hand
* Medical history of any inflammatory joint disease, septic arthritis, previous articular fracture of the concerned joints, monarticular post-traumatic OA of the finger, a history or the presence of any other rheumatic diseases that could cause secondary OA, such as hemochromatosis.
* Ongoing therapy with opioid analgesics and any kind of topical treatment
* Therapy with SYSADOAs other than GS, steroids by any route of administration and intra-articular injection of any joint with hyaluronic acid during the previous 6 months.
* Contraindications or special warnings for GS presented in the data sheet.
Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia

Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders, with a high impact on disability and participation. Poor adherence to pharmacotherapy negatively impacts on the course and outcome of PSS.

Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of relapse and readmission up to 5-time higher than in adherent patients. Falloon et al. developed a Psychoeducation Program (FPP) aimed at improving communication and problem-solving abilities in patients and their families. Past studies reported a statistically significant reduction of the risk of relapse in patients receiving the FPP, but did not take into account effects on adherence.

Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another group exposed to a treatment with generic informative prospects on the disorders provided with same attendance frequency as the FPP (Generic Treatment - GT).

Methods: 340 patients with PSS, from 10 participating units distributed in the territory of the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and concurrently with the administration of a 4-item interview, based on a modified version of the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method, followed by Log-rank test, defining as terminal events both the start of non-adherence and/or the first relapse or readmission episode. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate missing data.

Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already in contact with a psychiatric service is 47%; effect size of psychosocial treatment on various outcomes, including relapse, readmission and adherence to drug is 0.48 of the standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce a change in the prevalence of non-adherence to drug in the exposed group with an effect size of 0.45 SD.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;
* being in care for 2 years or more.

Exclusion Criteria:

* mental retardation, or any severe cognitive impairment;
* psychosis due to substance abuse or to a medical condition;
* affective psychosis;
* comorbid substance dependence;
* patient does not understand Italian language;
* pharmacotherapy with depot.
Dexmedetomidine to Prevent Agitation After Free Flap Surgery

Reconstruction using microvascular free tissue flap has been an important management in patients with maxillofacial tumor. It is often characterised as long operation time, more traumatic and require restriction of patient's head movement postoperatively in order to prevent disruption of microvascular anastomosis. Agitation and delirium are common in patients with free flap surgery, which may lead to serious consequences such as self extubation, injury or even failure of the flap.

Dexmedetomidine is a sedative and co-analgesic drug with high specificity for α2-adrenoceptor. It is widely used in ICU sedation in general hospital. However its use after free flap surgery is not well documented. Furthermore the effect of Dexmedetomidine on preventing delirium has not been proved.

The investigators hypothesized that the use of Dexmedetomidine would reduce emergence agitation and prevent delirium in patients after free flap surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing selected maxillofacial surgery with free flap reconstruction
* American Society of Anesthesiologist(ASA) classification I and II

Exclusion Criteria:

* bradycardia (\< 50 bpm)
* severe heart block
* low blood pressure(SBP\<80mmHg)
* Known allergy to alpha 2 agonists