cyrilzakka/clinical-trials huggingface dataset:
Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.

For the proposed study investigators plan to include total 60 patients with 30 each allotted to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade I/II/III, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and Institutional Review Board (IRB). All patients will receive one-third starvation fluid as crystalloid during first hour of surgery . Night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP - Radial),CVP(site IJV),core Temperature .

Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure Ventilation will be given to all patients.Patients will be allotted randomly to either Goal Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous Pressure - CVP guided fluid Therapy Group.

During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss , Seum lactate levels will be noted.

For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI) ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value \>11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV, SV, SVI and SVRI shall be recorded.

For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value \< 8 colloid bolus of 200ml will be given and change in CVP value will be noted.

Patients in both the groups will receive Noradrenaline infusion if MAP \<70 mmHg with optimal fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit \< 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds, Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of stay (hours in SICU) and any postoperative complications shall be noted.

Eligibility Criteria:
Inclusion Criteria:

* Elective major open gastrointestinal Oncosurgeries .

Exclusion Criteria:

* Patient refusal.
* Robotic surgery.
* Laparoscopic surgery.
* Arrythmias.
Hepatitis C (HCV) Cure and Kidney Health

The purpose of this study is to learn how 12 weeks of HCV treatment with elbasvir and grazoprevir (brand name Zepatier) impacts your kidney function.

Prospective data collection of 25 Genotype 1 or 4 HCV-infected women from the San Francisco Women's Interagency HIV Study (WIHS) site and 25 Genotype 1 or 4 HCV-infected men from the San Francisco VA Medical Center who are initiated on Zepatier for 12 weeks (Total n=50). For women and men with HCV genotype 1a infection, only those without baseline NS5A resistance mutations will be included. Blood/urine samples will be collected before initiation of treatment, 4 weeks after treatment initiation, 12 weeks after treatment initiation (end of treatment), 24 weeks after treatment initiation to determine Sustained Virological Response (SVR), and at 48 weeks after treatment initiation.

Eligibility Criteria:
Inclusion Criteria:

1. Active Genotype 1 or 4 HCV infection (If with Genotype 1a infection, only those without baseline NS5A resistance mutation will be included; Genotype 4 HCV infection is uncommon in both study populations). Subjects with HIV coinfection are included. We will not exclude patients who have severe Chronic Kidney Disease, are on dialysis, or have undergone kidney transplant.

Exclusion Criteria:

1. HCV genotype 2, 3, 5, or 6 infection
2. Previous virologic failure to regimens containing an NS5A inhibitor
3. Decompensated liver disease (Child-Pugh Class B or C)
4. Albumin below 3g/dL
5. Platelet count below 75,000
6. Any condition that the investigator considers a contraindication to study participation including limited life expectancy
7. Pregnant or breastfeeding woman
8. Hepatitis B virus (HBV) surface antigen positive (Note: Patients positive for the HBV core antibody will not be excluded, but will have HBV DNA levels checked and will be monitored while on Direct Acting Antivirals (DAA) therapy and medically managed as considered appropriate)
9. Documented ongoing nonadherence to prescribed medications or medical treatment, failure to complete HCV disease evaluation appointments and procedures or unable to commit to scheduled followup/monitoring for the duration of treatment
10. Poor venous access not allowing screening laboratory collection
11. Known hypersensitivity to elbasvir/grazoprevir
12. Co-administration with drugs that are 1) strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin); 2) OATP1B1/3 inhibitors (e.g., cyclosporine, darunavir, atazanavir, tipranavir, lopinavir or saquinavir) or 3) efavirenz
Metabolism and Pharmacokinetics of [14C]-DK-AH 269 CL in 12 Healthy Male Volunteers

* To investigate absorption, metabolism and excretion of \[14C\]-DK-AH 269 CL after oral and intravenous administration in healthy volunteers
* To assess the safety and tolerability of DK-AH 269 CL after oral and intravenous administration to healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* 50 to 65 years of age
* Body Mass Index (BMI) of 19.9 to 29.9 kg/m2
* Resting heart rate (HR) (after 5 min. in the supine position) of more than 55 bpm
* All volunteers will have given their written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.

Exclusion Criteria:

* Any finding at the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, hematological/oncological, immunological or hormonal disorders
* Diseases of the central nervous system or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within ten half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial within two weeks prior to administration or during the trial
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within 2 months prior to administration or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range and of clinical relevance
* Inability to comply with dietary regimen of study centre

Not necessarily clinically relevant abnormalities, but specific exclusion criteria for the drugs under study or for the study:

* Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
* ECG: PR interval \> 210 ms
* HR at rest ≤ 55 beats per minute (bpm)
* Relevant ophthalmological disease
Mindfulness Mobile App to Reduce Adolescent Substance Use

Substance-abusing youth - especially those who are involved in the juvenile justice system - are at higher risk than nonusers for mental health problems, including depression, conduct problems, personality disorders, suicidal thoughts, attempted suicide, and completed suicide. The proposed Phase II project aims to develop and test the efficacy of a mobile app, called Qlarity, that is geared toward helping high risk adolescent substance users reduce or quit their substance use. The Qlarity app is based on the primary substance use cessation components tested in our previous work with juvenile justice-involved adolescents and on intervention components shown to be central to smoking cessation; it applies a mindfulness approach as the guiding framework for the intervention.

There is growing evidence that interventions based on mindfulness have been an efficacious intervention for a variety of problems, including substance use among adolescents. We propose to adapt and test the feasibility and efficacy of a smart phone application (app) intervention prototype that would help adolescent substance users reduce or quit their substance use through the development of stress reduction, emotion regulation, and mindfulness skills. During the development process, 20 high-risk adolescents will be recruited for participation in focus groups and usability testing of early versions of the app; their initial reactions to content and functionality will help guide final iterations. Qlarity is a twelve module program, and each module consists of a teaching component and a practice component. Modules take 5 minutes or less to complete. Module topics include developing an awareness of mind and body states, mindful decision making, and maintaining sobriety.

In this study, the Qlarity app will be evaluated with 400 high risk adolescents that are involved in the juvenile justice system; the first 20 adolescents will be involved in the development process and the remaining 380 participants will be randomly and equally assigned to the Qlarity condition (n = 190) or the Department of Youth Services standard treatment condition (n = 190). Youth will be assessed at baseline and will be instructed to attempt to reduce substance use with a target quit date of 28 days in the future. The Qlarity group will receive instructions for using the app in the 28 days following baseline. All youth will complete 1 and 3 month follow-ups. Assessments will consist of online surveys asking about substance use, emotion regulation, family demographics, and mindfulness practices. The Qlarity group will also be asked for their thoughts and opinions on the app. Biochemical verification of self-reported substance use, a urine sample, will be collected at each interview.

Eligibility Criteria:
Inclusion Criteria:

* any gender, age 13-18
* recent involvement with juvenile justice system
* documented substance use
* English speaking
* living in the community (e.g., with biological/adoptive/foster parents)

Exclusion Criteria:

* non-English speaking
Campath-1H + FK506 and Methylprednisolone for GVHD

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

OBJECTIVES:

Primary

* Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.

Secondary

* Determine the best response at 4 and 12 weeks in patients treated with this regimen.
* Determine 6-month survival of patients treated with this regimen.
* Determine the rate of infectious complications in patients treated with this regimen.
* Determine rate of chronic GVHD in patients treated with this regimen.

OUTLINE: This is an open-label, single-blind, multicenter study.

Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.

After completion of study treatment, patients are followed at 2 and 4 weeks.

PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of acute graft-vs-host disease (GVHD)

  * Clinical grade C or D disease

    * No grade C disease with single organ skin involvement
* Has undergone allogeneic stem cell transplantation within the past 100 days

  * Absolute neutrophil count \> 500/mm\^3 (donor-derived \[\> 60% by peripheral blood lymphocyte chimerism analyses\])
* No development of GVHD after prior donor lymphocyte infusion
* Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* See Disease Characteristics

Hepatic

* No serologic evidence of active hepatitis B or C infection

Renal

* Creatinine ≤ 3.5 mg/dL
* No requirement for dialysis

Cardiovascular

* No requirement for vasopressors

Pulmonary

* No requirement for a ventilator

Other

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No known HIV positivity
* No active uncontrolled infection
* No other organ dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Effects of a Sedentary Behaviors at Work on Health in Emergency Medical Dispatchers and CODIS Operators (SECODIS)

The purpose of the study is to study changes in sedentary behavior following a behavioral intervention (sit-and-stand desk, and cycloergometer)

Each emergency medical services dispatcher and each firefighter participates in the study for three days. A normal working day from of 12h is compared to: (i) a working day during which the participants have to get up at least 5 min/hour (sit-and-stand desk), (ii) a working day during which they can use a cycloergometer installed under the desk. Conditions will be random using Latin Square design with stratification between sequences cross-over design on occupation (EMD vs. firefighters).

The heart rate variability (measured using Zephyr®), the electrodermal activity (Empatica® E4), the level of physical activity (Actigraph®) as well as the blood sugar (Freestyle®) will be measured continuously during the 12 hours of work and the night after except for Actigraph® and Freestyle® device that will be let one week. Blood and saliva samples will be collected on each working day, at the beginning and end of the day i.e. two measures for blood samples, and every three hours i.e. 5 measures for saliva sampling. Participants will have to complete a detailed questionnaire to identify the particular events (vital emergencies, etc.) that may influence the parameters measured.

Participants will be asked to answer a general questionnaire once at the start of the study that will cover different aspects:

* Sociodemographic,
* Visual analogue scale (VAS) related to psychosocial factors : stress at home, burnout / burnout, decision latitude / autonomy at work, psychological demands at work (workload), support from the hierarchy, support from co-workers, family support, job satisfaction with regard to effort, commitment to work, addiction to work, quality of life, need for psychological support,
* Eating habits.

They will then have to answer a short questionnaire at the beginning and at the end of each measurement day. It will cover different aspects:

* Four VAS (stress level, fatigue, anxiety, mood),
* Physical activity and sedentary lifestyle (number of hours of physical activity and sitting during the last 24 hours),
* Daily consumption (tobacco, alcohol, cannabis, coffee, tea).

Eligibility Criteria:
Inclusion Criteria:

* Emergency medical dispatchers or firefighters from the departmental fire and rescue operational center (CODIS).
* Person able to give an informed consent to participate in research
* Affiliated with a Social Security scheme.
* Being able to use the sit-stand desk and the cycle ergometer

Exclusion Criteria:

* Non-affiliated to a health insurance,
* Protected persons (minors, pregnant women, breastfeeding women, guardianship, curatorship, deprived of freedoms, safeguard of justice),
* Refusal to participate.
Male Factor Infertility Across India Using Aphrodite Criteria

Study Purpose:

The purpose of this study is to conduct an observational cross-sectional analysis of male factor infertility across diverse regions of India utilizing the Aphrodite Criteria. This novel patient classification system offers a systematic approach to describing and managing male infertility, particularly for hypogonadal males with idiopathic infertility. The study aims to evaluate the current state of male fertility across India and identify any regional variations in male reproductive health and hypogonadism, which may be influenced by environmental, lifestyle, and genetic factors.

Study Objective:

The primary objective of this study is to conduct an observational cross-sectional analysis of male factor infertility across various regions of India using the Aphrodite Criteria. To reveal the prevalence and determinants of male factor infertility across different regions of India.

Hypothesis:

We hypothesize that there are significant regional differences in male factor infertility characteristics across India, with variations in sperm quality and testicular function due to diverse environmental, lifestyle, and genetic factors. Additionally, we hypothesize that the application of the Aphrodite Criteria will provide a more detailed classification of male infertility compared to conventional semen analysis and that certain lifestyle factors such as smoking, obesity, and occupational exposures will be associated with poorer sperm quality and testicular function.

Study Population:

The study population will consist of male patients visiting clinics across different IVF centers in India. The total sample size includes subjects from five groups with the following distribution:

35 subjects in Group I ; 416 subjects in Group II; 270 subjects in Group III; 152 subjects in Group IV; 216 subjects in Group V

The total sample size for all groups will be 1,090 subjects.


Eligibility Criteria:
Inclusion Criteria:

* All male visiting IVF clinic willingly giving consent for andrological evaluation.

Exclusion Criteria:

* NONE
Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France

The Coalition on Psychiatric Emergencies (CPE) stressed in 2016 that emergency providers were increasingly recognizing the important role of the Emergency Department (ED) in reducing adverse outcomes associated with untreated with substance abuse liaison department (SUDs). Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD. Of the more than 4.5 million ED visits in 2009 in US for drug-related causes,34-32% involved alcohol use alone or in combination with other drugs. Few studies investigated the clinical characteristics of patients referred to an addiction liaison department in a general hospital. The present study will be retrospective in a sample of 700 patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.


Eligibility Criteria:
Inclusion Criteria:

* patient addressed to University Hospital Emergency Department and consecutively referred to a substance abuse liaison department in the Amiens Academic Hospital, France between 2017 and 2020.
* Patients must be able to speak French

Exclusion Criteria:

* Neurological disorders
* patients who are not able to speak French
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.


Eligibility Criteria:
Inclusion Criteria:

* advanced NSCLC,
* more than 20 years old,
* measurable tumor,
* response and outcome recorded after the first line treatment.

Exclusion Criteria:

* Early stage NSCLC,
* less than 20 years,
* pregnancy,
* unmeasurable NSCLC.
Study of Scaling Disorders and Other Inherited Skin Diseases

The purpose of this study is to identify the genes responsible for certain scaling disorders and other inherited skin diseases and to learn about the medical problems they cause. In some cases, these may include problems affecting organs other than the skin, such as the eyes, teeth and bones.

Patients with inherited skin disorders, including Darier's disease (keratosis follicularis), lamellar ichthyosis, epidermolysis bullosa, cystic acne, and others, and their relatives may be eligible for this study. Patients will have a medical history, physical examination with particular emphasis on the skin, and routine blood tests. Additional procedures for patients and unaffected relatives may include:

1. Blood sample collection
2. Dental exam with X-ray of the jaw
3. Eye examination
4. X-rays of the skull, ribs, chest, hands, feet, spine, arms, or legs
5. Bone density scan
6. Photographs of the skin
7. Skin biopsies (removal of a small tissue sample under local anesthetic)
8. Buccal sample (gentle brushing inside the cheek to collect a cell sample) for gene studies

Patients who request the results of their gene testing will be provided this information.

We propose to investigate the genetics of the scaling disorders and other genodermatoses which are believed to behave in a Mendelian manner. Families for study will be ascertained through articles in the Ichthyosis Focus, (the newsletter of the Foundation for Ichthyosis and Related Skin Types), physician referrals, and patient self-referrals. Efforts will be made to further characterize the clinical findings in both affected persons and unaffected gene carriers. Using candidate genes, especially those known to be involved in structural abnormalities of skin, we will attempt to map and isolate major genes contributing to expression of the disease phenotype. Failing this direct approach, a random search of the genome (so-called, "reverse genetics") will be utilized. In addition, normal and diseased skin will be used in cell culture and animal experiments (under a separate protocol) to test new therapeutic modalities.

Eligibility Criteria:
No steroid sulfatase deficiency.