cyrilzakka/clinical-trials huggingface dataset:
Prediction of Abdominal Complications After GastroEnterological Surgery

The aim of this multi-centered study is to understand the epidemiology of infectious complications after gastrointestinal surgery in China. In total, 17 centers from China will prospectively register their patients undergo gastric or colorectal surgeries. Patient demographic data, operation information, and postoperative data including the infectious complications and the outcomes will be registered. We expect to include 2000 gastric and 2000 colorectal patients within one year and the study is expected to be finished in 2020.

All participating hospital will log in on a website based e-CRF system. Researchers need to register the patient information that three time-points: admission, after surgery, after discharge.

The detailed registered information includes:

I. Basic and surgical information:

Age, height, weight, history of abdominal surgery, ASA score, surgical procedure, extent of lymph node dissection, extent of resection, time of surgery, amount of bleeding, whether it is emergency surgery, whether it is combined with organ resection, whether it is palliative resection, whether combined with preoperative treatment, whether combined with preoperative infection and intraoperative complications.

II. Postoperative information:

Primary lesion histological type, margin, pathological stage (pTNM); other complications, postoperative death and discharge time, CRP, PCT, WBC levels.

III. Abdominal Infection information:

Abdominal infection (Y/N), anastomotic leakage (Y/N), intervention, outcome.

Eligibility Criteria:
Inclusion Criteria:

* Planned gastrointestinal surgery.
* Inform consent received.

Exclusion Criteria:

* Endoscopic surgery.
* Inform consent denied.
An Observational Study of Patients Living With Chronic Neurological Diseases

TARGET-NEURO is an observational research study to conduct a comprehensive review of outcomes for patients living with chronic neurological diseases: Alzheimer's disease and related dementia (ADRD), mild cognitive impairment (MCI), Parkinson's disease (PD), and multiple sclerosis (MS).


Eligibility Criteria:
Disease Cohort

Inclusion Criteria:

•Adult patients at the time of enrollment with a diagnosis of ADRD, MCI, PD, or MS by select ICD-10 codes in the EHR interface

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years

Engaged Cohort

Inclusion Criteria:

* Adult patients diagnosed and managed for these conditions invited to participate
* Ability to provide written informed consent (or have a legally authorized representative to provide informed consent)
* Care partners may be invited to participate in surveys and will provide informed consent.

Exclusion Criteria:

* Patient expressed desire to withdraw consent to complete PROs
* Care partner expressed desire to withdraw consent to complete PROs
* Failure to complete PROs within 24 weeks of initial invitation
* Greater than 24 months lapse of survey completion after baseline surveys completed
* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort

Age Cohort

Inclusion Criteria:

•Adult patients aged 60 and older at time of enrollment

Exclusion Criteria:

* Death
* Manual removal (sponsor or site request)
* No EHR interface encounter \> 3 years
Safety Aid Reduction Treatment for PTSD Among Veterans

The purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) among Veterans with posttraumatic stress disorder (PTSD). It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.

Rates of posttraumatic stress disorder (PTSD) among military personnel have surged in recent years. In response, the Department of Veterans Affairs (VA) has launched nationwide training initiatives to disseminate two PTSD treatments with strong empirical support: prolonged exposure (PE) therapy and cognitive processing therapy (CPT). Despite the well-documented effectiveness of PE and CPT, only a minority of Veterans with PTSD initiate these trauma-focused treatments. One approach to addressing PTSD in a non-trauma-focused fashion is to utilize empirically supported treatments focused on safety aid reduction. Safety aids are maladaptive cognitive and/or behavioral strategies designed to prevent, avoid, or alleviate anxiety. Initially introduced as a way to explain how pathological anxiety can persist despite repeated exposure to feared stimuli, safety aids have been found to play a critical role in the etiology and maintenance of various anxiety and related conditions including PTSD. Importantly, a separate line of research suggests that safety aids are amenable to change through cognitive behavioral interventions. Although promising, these trials did not include patients with PTSD. In this context, the purpose of this project is to examine the acceptability, feasibility, and utility of a safety aid reduction treatment (START) for PTSD. Participants will include veterans with a diagnosis of PTSD who decline to participate in evidence-based psychotherapies (EBPs) for PTSD, namely PE or CPT. It is hypothesized that START will be acceptable, feasible, and will lead to reductions in PTSD symptom severity immediately and over time.

Eligibility Criteria:
Inclusion Criteria:

* Veterans receiving care at New Orleans VA
* Veterans with diagnosis of PTSD who decline trauma focused treatment

Exclusion Criteria:

* Substance dependence requiring detoxification
* Active psychosis
* Uncontrolled Bipolar Disorder
* Severe suicidal intent requiring hospitalization
* Current engagement in psychotherapy
Treatment of Atrophic Acne Scars With Platelet-Rich Plasma and Skin Needling

Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).

Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.

Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.

Eligibility Criteria:
Inclusion Criteria:

* Atrophic acne scars on both sides of the face

Exclusion Criteria:

* patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
* systemic retinoids intake in the previous 6 months,
* diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
* patients on anticoagulant therapy or aspirin or have a coagulation issue,
* patients with hemoglobin less than 10g\\dl or platelet less than 105 micron\\l
* any previous procedures for acne scar within the last 6 months
Long Term Follow-Up for Safety of AVR-RD-02

The goal of this observational study is to assess the safety and tolerability of AVR-RD-02 treatment in subjects who previously received AVR-RD-02 treatment (single dose administration).

Subjects who received AVR-RD-02 in the preceding treatment study (NCT04145037) and who meet all eligibility criteria may participate. Subjects will be asked to return for study visits annually for 14 years to assess measures of safety and persistence of AVR-RD-02 treatment.

Eligibility Criteria:
Inclusion Criteria

Subjects must meet all of the following inclusion criteria for participation in this study:

1. Subject must be willing and able to provide written informed consent for the JAB-GD-001 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures.
2. Subject must have been enrolled in the preceding AVROBIO AVRO-RD-02-201 treatment study and have received AVR-RD-02 treatment

Exclusion Criteria

Subject has any medical, psychological, or other condition that, in the opinion of the Investigator:

* Might interfere with the subject's participation in the study (including consenting to procedures); and/or
* Poses any additional risk to the subject; and/or
* Might confound the results of any study-required assessments.
Diet / Gut Microbiome Interaction and Influence on Inflammatory Disease in HIV Patients

The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.

This is a randomized clinical trial. Fifty (50) Antiretroviral therapy (ART)-treated Human immunodeficiency virus (HIV) positive participants, 24 HIV negative controls matched for age and sex, and 24 HIV negative controls from a population at high risk for contracting HIV will be recruited into 3 cohorts. All participants will undergo a 4 week diet modification and will be randomly assigned to receive either an Agrarian diet or a Western-type diet. For the first 2 weeks, food will be provided to the participant, followed by an additional 2 weeks where participants will be provided a diet menu with recipes to prepare themselves. There will be 4 study visits and participation will last for up to 2 months.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected cohort (Cohort A)

  * Documentation of HIV-1 infection defined as a positive antibody test or plasma HIV-1 RNA (ribosomal ribonucleic acid).
  * Treated with ART (minimum of three antiretroviral drugs in regimen) for at least 12 months with no changes in antiretroviral drugs over the past 6 months
  * Plasma HIV-1 RNA ≤ 50 copies/mL in the preceding 6 months.
* HIV-negative cohorts (Cohort B and C)

  * Documentation of a negative HIV-1 antibody test
* All Cohorts

  * Age 18 to 65 years
  * Body mass index between 21-29 kg/m2 (non-obese)
  * Stable weight for at least 3 months (≤15% change in body weight)
  * Negative pregnancy test (if female)

Exclusion Criteria:

* Use of systemic (oral or parenteral) antibiotics within two months prior to study entry
* Active chronic infection such as hepatitis B or C or an active malignancy that requires systemic chemotherapy.
Russian Disc Degeneration Study

The main aim of this study is to establish disease-oriented biobank to facilitate research in biology of the lumbar disc degeneration. Diverse biological samples (whole blood, plasma, disc tissue) along with MRI imaging, clinical, socio-demographic and various omics data (e.g. genomic and transcriptomic) will be available for researchers and clinicians for a variety of further multi-omics studies. It will lay the groundwork for the development of early diagnostics of DDD and its personalized treatment.

The study is planned to enroll up to 1,100 patients with different grades of lumbar disc degeneration. It is planned to recruit patients within 36 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18;
2. Presence of lumbar MRI scans;
3. Signed informed consent for voluntary participation is provided.

Exclusion Criteria:

1. Any contraindication or inability to undergo baseline procedures;
2. Prior surgeries at any level of the lumbar spine;
3. Other non-degenerative spinal conditions that may have an impact on subject safety, wellbeing or the intent and conduction of the study;
4. History or presence of HIV, hepatitis B, hepatitis C.
Shanghai Ovarian Cancer and Family Care Project

Ovarian cancer is the most lethal gynaecological malignancy, but its incidence in the general population is low. Due to the lack of effective prevention and successful screening approaches, most cases are diagnosed at advanced stages, leading to poor prognosis. In order to address the research requirements pertaining to ovarian cancer, the Shanghai Ovarian Cancer and Family Care Project was established. This initiative offers hospital-based resources for investigating ovarian cancer and high-risk populations. The project comprises an on-going ovarian cancer cohort, a high-risk population cohort, and a healthy population cohort. By leveraging these comprehensive cohorts, the project provides a unique platform for in-depth studies on the detection, prevention, early diagnosis, treatment, and prognosis of ovarian cancer.


Eligibility Criteria:
Participant meet the criteria for one of the following conditions:

* Patients attending the oncology department require differential diagnosis of ovarian cancer.
* Patients with known high-risk factors for ovarian cancer, such as history of ovarian cancer or BRCA-associated cancer, etc.
* Patients attending the Physical Examination Center who have normal findings on physical examination and no symptoms.

Exclusion Criteria:

* Individuals with evidence of another active cancer.
* Individuals who have prior bilateral oophorectomy.
* Individuals who are unwilling or unable to sign the informed consent form.
Individualized Preoperative Rehabilitation Pilot

A pilot to test feasibility of improving patient/caretaker quality of life and resilience.

Our overall goal is to investigate if pre-operative interventions can address patients' and patients' care givers quality of life/resilience deficits and thus improve outcomes. This initial pilot study will test the feasibility of offering patients and their care givers prehabilitation interventions prior to complex gastrointestinal surgery such as pancreatectomy, esophagectomy, proctectomy, or hepatectomy.

Eligibility Criteria:
1. Patients who are being seen for pancreatic, esophageal, rectal or hepatic neoplastic disease, will undergo neo-adjuvant therapy and may require complex GI surgery and their care givers.
2. Are able and willing to participate in all aspects of the study; and
3. Have been provided with, understand the consent.
Automated V Manual Impactor Study

This study investigates the use of an automated impactor device in total hip arthroplasty versus manual malleting method and the physiological strain on the surgeon. This study will be a randomized, prospective, multicenter study involving fellowship-trained arthroplasty surgeons. Each participating surgeon will contribute data from 50 primary, elective THA cases, using the HAMMR powered impactor in 25 cases and manual impaction in 25 cases.


Eligibility Criteria:
Inclusion Criteria:

Patients undergoing primary elective THAs Participants over the age of 18 Patients with compatible implants

Exclusion Criteria:

Attending orthopaedic surgeons with pre-existing cardiorespiratory or musculoskeletal conditions Use of cemented or hybrid THA Patients undergoing a conversion or revision THA Patients undergoing a non-elective THA (i.e., for fracture) Participants lacking cognitive capacity to consent Participants who are pregnant
Hepsera Versus Hepsera Plus Lamivudine for Treatment of Chronic Hepatitis B in Patients With Normal ALT

This project is a randomized, open-label trial of adefovir dipivoxil (Hepsera) and lamivudine combination therapy versus adefovir dipivoxil (Hepsera) monotherapy. Both adefovir dipivoxil and lamivudine are nucleoside analogues approved by the U.S. FDA for the treatment of chronic hepatitis B.

The primary hypothesis is that subjects treated with combination therapy will see their viral DNA count decrease in an amount greater than subjects treated with monotherapy. The secondary hypothesis is that subjects treated with combination therapy will have a higher HBeAg conversion rate compared to historical controls of subjects treated with lamivudine or adefovir dipivoxil monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years
* HBsAg+ at screening and for at least 6 months prior to study entry
* HBeAg+
* HBV DNA greater than 6 log10 copies/mL
* Platelet count greater than 50,000 platelets/mm3
* Hemoglobin greater than 7.5 g/dL
* ALT less than ULN
* Estimated creatine clearance\>50 mL/min as estimated by the Crockcroft-Gault equation ((140-age) x (kg)/(serum creatine x 72) (for women x 0.85))
* Female and male participants must be practicing an effective form of contraception (male or female condom with spermicide, diaphragm or cervical cap with spermicide, intrauterine device, hormonal contraception)
* Serum alpha-fetoprotein less than 50 ng/mL within 30 days of study entry
* Childs-Pugh score less than 7 and no ascites, variceal bleeding, or hepatic encephalopathy
* able to give written informed consent and to comply with the study protocol

Exclusion Criteria:

* history or evidence of HIV, hepatitis C or hepatitis D
* known or suspected hypersensitivity to adefovir or other nucleoside/nucleotide analogs.
* history of clinically significant renal dysfunction
* any active medical or psychiatric illness that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol
* pregnancy or breastfeeding
* receipt of systemic corticosteroids within 90 days of study entry
* receipt of nephrotoxic drugs within 8 weeks prior to study screening or expected use of these agents during the course of the study
Physiotherapy for Children With Sickle Cell Disease: A Randomized Controlled Trial

Primary aim to determine the effects of immersive VR on pain management in children with SCD.

Secondary aim to determine the effects of immersive VR in musculoskeletal dysfunction in children with SCD and health-related quality of life.

We hypothesized that:

1. Immersive VR would significantly improve pain in children with SCD.
2. Immersive VR would significantly improve musculoskeletal function in children with SCD.
3. Immersive VR would significantly improve the health quality of life according to children.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria are as following: patients aged between 6-18 years of both genders diagnosed with SCD, with hip avascular necrosis (AVN), with joints pain, children with SCD post hip surgery, with motor impairment and gait difficulty, with restricted ROM in lower limb, children with recent crisis of SCD.

Exclusion Criteria:

* The exclusion criteria are the children with previous stroke or other neurologic disorders and cardiopulmonary disorders that limits the functional activities of the participants will be excluded.
Efficacy And Safety Study Of Pregabalin (Lyrica) As Monotherapy In Patients With Partial Seizures

This study will determine the safety and efficacy of pregabalin (Lyrica) when administered by itself (without any other anti-epileptic medication) to epilepsy subjects for the treatment of partial seizures. The duration of the trial is about 6 months.

After review of the interim analysis results, the independent Data Monitoring Committee (DMC) recommended to stop the study based on positive efficacy findings for the primary efficacy endpoint according to pre-specified stopping rules. Pfizer accepted the DMC recommendation and made the decision to stop the study on September 7, 2011.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of epilepsy with partial seizures.
* Males or females, age 18 years or older.
* Documented history of at least 4 partial seizures in the 8 weeks prior to the screening visit.
* Stable treatment with 1 to 2 anti-epileptic drugs in the 8 weeks prior to the screening visit.

Exclusion Criteria:

* Current diagnosis of febrile seizures or seizures related to an ongoing acute medical event.
* Seizures occurring only in cluster patterns, or seizures of a metabolic, toxic or infectious origin.
* Primary generalized epilepsy or status epilepticus within the previous year.
Effectiveness of the New Perilaryngeal Airway in Comparison With the Laryngeal Mask Airway

The Laryngeal Mask Airway (LMA) has been used widely for different patients and found to be highly safe for adult and pediatric patients. However, the LMA has some limitations and weaknesses (e.g. more insertion attempts in 5% to 10 % of all cases. Despite the easy insertion of the LMA, it is crucial to check correct placement of the LMA airway.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 to 35 kg/m2
* scheduled for surgery
* being older than 18 years
* Mallampati class I-III and BMI between 25 and 35

Exclusion Criteria:

* pregnancy
* morbid obese (BMI\>35 kg/m2)
* a known difficult airway
* gastro-oesophageal reflux
* pharyngeal pathology
* emergency operation with full stomach
Simplified Model of Linkage and Retention to Care, Using a Mobile Unit and a Same-day Test and Treat Approach Among Excluded Population. (SIMPLIFIED)

Implementation of a model for access and retention of HIV care for vulnerable and excluded population using a mobile screening unit and a strategy of diagnosis and initiation of treatment with Bictegravir (BIC) 50 mg/ Emtricitabine (FTC) 200 mg / Tenofovir Alafenamide (TAF) 25 mg.

The use of a mobile unit to reach vulnerable HIV-infected people with poor access to the health care system and starting/restarting on the same day ("simplified same day test and treat strategy") is feasible, effective and safe and will allow these people to have a rapid access to ART and long-term follow-up and health care for HIV.

At the screening visit the patient will sign the informed consent form, revise the clinical history and ensure compliance with criteria. A history of drug abuse, complete physical examination, pregnancy test, rapid hepatitis C test, questionnaires and social situation will be collected from the patient.

At the basal visit the patients enrolled in the study will collect lab test (blood count, biochemistry, coagulation, serology, inmunology and virology), vital signs and directed physical examination, concomitant medication and adverse events.

After the basal visit the patient will be followed up on visits week 4, 12, 24, 48 and last visit 50 as follow up safety visit.

Eligibility Criteria:
Inclusion Criteria:

* Vulnerable person ≥18 years
* Understand and sign the informed consent form
* Confirmed HIV infection
* Not receiving ART or on ART with a PVL \> copies/ml

Exclusion Criteria:

* Unable to provide contact details
* History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine
* Taking antiretroviral treatment for less than 1 month
* Pregnancy or breastfeeding at the time of screening or gestational desires during the study period.
* Suspected or diagnosed of active opportinistic disease
* History of severe liver disease (Child- Pugh C) or history of descompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice)
* History of kidney disease CKP-EPI\< 30ml/min
* Have any condition that, as per investigator criteria, makes the patient not candidate to be included (active disease, social situation, intoxication...)