cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Intravenous (IV) Infusion and Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Crohn's Disease

Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. CD may cause tiredness, loose stools with or without bleeding, abdominal pain, weight loss, and fever. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active CD. Adverse events and change in the disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of CD. In the induction period, there is a 1 in 5 chance that participants will be assigned to placebo. Depending on the dose received in the induction period, there is a 1 in 2 or 1 in 3 chance that participants will be assigned to placebo in the maintenance period. Around 265 participants 18-75 years of age with moderately to severely active CD will be enrolled in the study at approximately 200 sites worldwide.

The study is comprised of a 12-week double-blind, placebo-controlled induction period, followed by either a 12-week double-blind re-induction period for non-responders or a 40-week double-blind placebo-controlled maintenance period for responders. In the maintenance period, responders will be randomized to receive subcutaneous placebo or ABBV-154 in 2 different doses every other week. Participants in the placebo group who are initial responders will receive ABBV-154 in the maintenance period.

There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Crohn's Disease (CD) for at least 3 months prior to Baseline of the Induction Period.
* Crohn's Disease Activity Index (CDAI) score 220 to 450 at Baseline of the Induction Period.
* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of \>= 6 for ileocolonic or colonic disease or SES-CD of \>= 4 for isolated ileal disease as scored by a central reader. All eligible scores must exclude the presence of narrowing component.
* Demonstrated intolerance or inadequate response to one or more of the following biologic agents: infliximab, adalimumab, certolizumab pegol, vedolizumab, natalizumab, ustekinumab, or risankizumab.

Exclusion Criteria:

- Participants with prior intolerance to adalimumab.
Adjunctive Photodynamic Therapy in Treatment of Chronic Periodontitis

The aim of this study is to verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis by assessing clinical and microbiological and immunological parameters. This is a randomized, controlled, double-blind, parallel clinical trial. Thirty eight patients with chronic periodontitis will receive conventional periodontal treatment. After eight weeks, patients will be re-evaluated and sites with residual pockets (PD ≥ 5 mm ) will be selected as experimental sites, and will be allocated to test and control group randomly. The test group will receive the application of PDT and the control group will receive sham procedure. The clinical parameters will be evaluated at baseline, 3, 6 and 12 months after treatment. Subgingival plaque will be collected before PDT, a week after, 3, 6 and 12 months later. The microbiological evaluation will detect and quantify periodontal pathogens such as Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Aggregatibacter actinomycetencomitans with real time-PCR. During follow-up, patients will receive periodontal maintenance every 3 months, as well as the application of PDT or sham

The goal of periodontal treatment is to restore tissue health through the elimination and control of etiologic factors, reducing the microbial aggression. Some microorganisms persist in the root surface even after scraping. Thus, the conventional mechanical treatment may fail to reduce the number of periodontal pathogens to levels compatible with health. This study will verify the efficacy of Photodynamic Therapy (PDT) as an adjunct to non-surgical treatment of chronic periodontitis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Periodontitis (Tonetti, Claffey, 2005)
* 10 or more teeth
* 2 or more site with probing pocket depth ≥ 5 mm, with or without bleeding on probing, after re-evaluation

Exclusion Criteria:

* Profilatic antibiotics
* Diabetes, immunosuppression, pregnancy nursing mother
* Smoking
* Medication that might interfere with periodontal healing
* Previous periodontal treatment or antibiotics (6 months)
* Experimental teeth with mobility II or III, or endodontic problem
Pain Trajectories in Severe Persistent Inguinal Post-herniorrhaphy Pain

Severe persistent postsurgical pain (PPP) remains a major healthcare challenge. In the third most common surgical procedure in the UK, inguinal herniorrhaphy, including 85,000 surgeries in 2015, an estimated 1,500 to 3,000 patients will annually develop severe PPP. While the trajectory of PPP is generally considered a continuation of the acute post-surgery pain, recent data suggest the condition may develop with a delayed onset. The present study evaluated pain-trajectories in a consecutive cohort referred to a tertiary PPP-center. Explanatory variables based on individual psychometric, sensory and surgical profiles were analysed.

Severe persistent post-surgical pain (PPP) is a prevalent medical problem leading to impairment of physical and psycho-social functions in a large number of individuals.Severe PPP may significantly influence 4-8% of the surgical population, depending primarily on the surgical procedure and technique, but also patient-related pre-surgical factors.Updated criteria for PPP have recently been suggested. Inguinal herniorrhaphy qualifies for PPP-research due to a high surgical volume. Paradoxically, while the surgery is considered a minor procedure with limited tissue damage it is carried out in a territory with abundant nerve and vascular supply, and, complex musculoskeletal functions essential for locomotor actions. Persistent pain after inguinal herniorrhaphy may develop after a seemingly successful surgical procedure, and, is seen in a severe form in 2-4% of the patients associated with significant deterioration of the health-related quality of life.

The transition process from acute to persistent pain may be more complex than previously assumed, making the study of temporal pain trajectories interesting. Based on clinical experience from a nationwide research center in PPP following inguinal herniorrhaphy, the authors decided first, to perform a prospective exploratory cohort study examining graphical pain charts by planimetrics, attempting to construct a valid statistical sub-classification of the trajectories. Secondly, the relationship between the sub-classification of the trajectories, and, potential explanatory variables, based on individual profiles of pain, psychometrics, quantitative sensory testing, and surgical procedures, were analysed, using principal component analysis and logistic regression models.

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe persistent pain (\>6 mo) after groin hernia repair referred to our center for PPP

Exclusion Criteria:

* Unable to cooperate with the sensory examinations
Ilioinguinal Nerve Block in Transcatheter Aortic Valve Implantation

To assess the effect of iliohypogastric and ilioinguinal nerve block on the hemodynamic stability ,narcotic consumption and the rate of conversion to general anesthesia in patients undergoing transfemoral transcatheter aortic valve implantation (TF-TAVI).


Eligibility Criteria:
Inclusion Criteria:

* • Patients undergoing TF-TAVI.

  * Both sexes.
  * Age 18 and above

Exclusion Criteria:

* • Inability to tolerate supine position as in patients with musculoskeletal disease or back pain, OR in patients with congestive heart failure or with obstructive sleep apnea.

  * Patients with severe pulmonary hypertension (PAP\>60 mmhg)
  * Barrier to communications as language barrier or dementia.
  * Patients' preference of general anesthesia.
  * Surgical consideration as transapical, subclavian approach, extensive TEE requirements.
  * Patients with history of allergy to any drugs used.
  * Patients with psychiatric disease.
  * Patients with neurocognitive or neurodegenerative disease.
  * Secondary exclusion criteria include abortion of the procedure, perioperative emergency conversion to general anesthesia and the need to cardiopulmonary resuscitation so the primary endpoint couldn't be detected in these conditions.
Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures

The objective of this investigation is to confirm the results obtained in a pilot study showing that certain radiological parameters based on computed tomography (CT) scans seem to reliably detect posterior ligament complex (PLC) injury without the need for Magnetic Resonance Imaging (MRI)

Integrity of posterior ligament complex (PLC) has an important bearing on the treatment strategies for thoracolumbar (TL) fractures. Magnetic Resonance Imaging (MRI) is the gold standard to confirm PLC injury. The routine use of MRI has its limitations especially since in most trauma centers MRI is not the primary assessment for TL fractures due to reduced availability, increased cost and its adverse applicability in trauma setting and in case of a polytrauma. In contrast computed tomography (CT) scans are an integral part of trauma evaluation protocols, are accurate in spine fracture diagnosis and are performed in less time, making them suitable to assess polytrauma scenarios. In a recent pilot study, a number of radiological parameters based on CT scans have shown to reliably detect PLC injury when compared to MRI. The aim of the study is to reconfirm and validate these CT based parameters to assess PLC injury compared to MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 60 years
* A3/A4 TL fracture between T11-L2 with or without PLC injury
* Pre-treatment CT scan and MRI. Radiographs (if available)
* Signed Informed consent, if required by EC/IRB

Exclusion Criteria:

* Pathological fractures
* Multilevel contiguous and non-contiguous injuries
* Fractures with obvious spinous process split indicating tension band failure such as AO type B1 injuries
* Fractures with translation injuries or dislocations such as AO type C injuries
Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).

To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.


Eligibility Criteria:
Inclusion Criteria:

* Willingness and ability to sign and date the study-specific informed consent form.
* Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
* Age greater than 18yo.
* Stage I-III TNBC or stage IV TNBC with intact breast primary.
* Planned combined ICI therapy as per SoC by treating oncologist.

Exclusion Criteria:

* Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
* Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))
Office Practice Assessment of Carotid Atherosclerosis Using Handheld Ultrasound (OPACA) Study

The purposes of this study are to determine:

1. Inter-site variability in CIMT image measurement using SonoCalcTM.
2. If non-sonographer health care professionals working in an office practice setting can be trained to follow a carotid scanning protocol that permits (a) accurate measurement of CIMT and (b) determination of plaque presence.
3. If (a) CIMT measurements and (b) determination of plaque presence by non-sonographer health care professionals are bioequivalent to those made by a core laboratory.
4. If CIMT measurements and plaque assessment performed in office practices lead to meaningful changes in patient and physician behavior related to cardiovascular disease prevention.

Phase

IV

Type (observational vs. interventional)

Observational

Currently recruiting or not?

NO

Randomized? (or not)

No Blinded? (single, double, or open)

Primary outcome(s)

Bioequivalency of carotid IMT measurements.

Secondary outcome(s)

Variability in carotid IMT measurements Intention to behavior change in patients Effects of carotid IMT on physician management

Type of Intervention (e.g., drug; device; behavioral)

Device

Name of Intervention

Handheld ultrasound measurement of carotid IMT

Eligibility Criteria:
Inclusion Criteria:

* Males over 45 years and females over 55 years of age with at least one additional risk factor for coronary artery disease.
* Females 45-54 years old may be enrolled if they have a family history of CHD (myocardial infarction, coronary artery bypass graft surgery, angioplasty, sudden cardiac death) in a male first degree relative \<55 or a female first degree relative \<65 years old AND at least one additional risk factor for coronary artery disease.

Exclusion Criteria:

* Age \>70 years
* Subjects taking cholesterol-lowering medications
* Active liver disease
* Active thyroid disease
* Uncontrolled hypertension
* Chronic kidney disease
* History of coronary artery disease
* History of cerebrovascular disease
* History of peripheral arterial disease
Natural Versus HRT Cycles in Frozen Embryo Replacement Treatment

Frozen Embryo Replacement (FER)is a fertility treatment by which stored embryos from a fresh IVF treatment cycle are thawed and transferred into the uterus. Frozen embryos can be replaced either in the middle of a natural menstrual cycle (Natural FER) or in a cycle where the woman takes drugs to suppress her own hormones, and then takes Hormone Replacement Therapy (HRT) to prepare her uterus for the transfer of embryos(HRT - FER).

Both are widely used methods of fertility treatment. However, to date no well designed studies have been reported in which the two methods have been compared. This study aims to compare the two treatments in order to establish the best treatment protocol.

The study design is a single centre open randomized controlled trial funded by the Oxford Fertility Unit.

100 women who are considering FER treatment at the Oxford Fertility Unit and are eligible for the study will be recruited.

After giving their written consent they will be randomised to one of 2 groups: Natural FER and HRT FER.

Patients in both groups will be asked to attend one initial visit, which is additional to patients not taking part in the study.

Subsequent visits will depend on the treatment group but will not be additional for study participants. All visits requiring ultrasound will involve recording 3-D measurements, which increases the length of each visit by approximately 10 minutes. A patient satisfaction questionnaire would be completed at the end of the cycle.

A urinary pregnancy test is performed at home 2 weeks following the embryo transfer visit. If this is positive then further visits to the unit are arranged to confirm the clinical pregnancy.

Inclusion in the study would not increase the length of time of either treatment cycle. Follow up would extend to obtaining pregnancy outcome information.


Eligibility Criteria:
Inclusion Criteria:

* Women attending Oxford Fertility Unit planning a frozen embryo replacement cycle.
* Willing and able to give informed consent for participation in the study.
* Age at original fresh IVF cycle \< 40 years old.
* At least 3 embryos frozen in storage
* First or second FER cycle
* Regular ovulatory menstrual cycles, confirmed by luteal progesterone levels \>16nmol/L and with cycle length \< 35 days.

Exclusion Criteria:

* Women with irregular cycles (outlined above), including amenorrhoea or oligomenorrhoea.
* Co-existing medical illness including renal, cardiac and liver disease
* Women for whom the study medication(s) are contraindicated or who have known allergic reactions to study medication(s)
* Women who have already taken part in this trial (i.e. cannot have more than one treatment cycle as a participant in this trial)
Syndemics and Loss from the HIV Care Continuum in India - Intervention

The investigators will assess the feasibility and acceptability of a pilot intervention to keep people living with HIV (PLHIV) in southern India in care and virologically suppressed. The lack of understanding of the causes of loss from the HIV care continuum in India stifles the armamentarium of effective interventions to keep Indian PLHIV in care. The results of this research will demonstrate the feasibility and acceptability of a pilot intervention targeting the multiple mechanisms by which PLHIV become lost to care. By targeting these mechanisms, this intervention will be designed to be scalable in a setting where access to mental health specialists is limited.

This pilot intervention represents the final Aim of the NIMH-sponsored study "Syndemics and Loss from the HIV Care Continuum in India." This trial will be conducted at the Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE), located in Chennai, the capital of Tamil Nadu state and one of the epicenters of the Indian HIV epidemic.

The investigators will recruit 50 adult (age \>=18) PLHIV presenting to care at YRG CARE and ART-naïve. Participants will be recruited at their first visit to YRG CARE, at which the participant's HIV diagnosis is established or confirmed and the participant receives initial counseling and clinical care. At this recruitment stage, research assistants will conduct a pre-intervention questionnaire including measures of depressive symptoms, internalized stigma, self-efficacy, mental health, and physical health. The investigators will then randomize the patient to usual care vs. enhanced-care intervention (25 in each arm).

The enhanced-care intervention will be multi-faceted, reflecting the likelihood of multiple syndemic conditions as well as evidence from LMICs suggesting that programs combining multiple approaches are the most effective in improving retention in care.

The enhanced-care intervention will consist of the following components:

1. Active outreach, including bidirectional weekly SMS messaging / automated voice messaging (depending on literacy)
2. Appointments (specific appointment times/dates).
3. Financial support, including free clinic visits, labs, medications, and transportation incentives on a sliding scale based on distance to clinic
4. Microenterprise, including bag-making or food-making ventures for women
5. Enhanced counseling. Participants in the enhanced-care intervention will participate in an individual enhanced counseling program called Steps to Success, based upon a Life Steps and Problem Solving curriculum.

Eligibility Criteria:
Inclusion Criteria:

* Adult PLHIV presenting to care at YRG CARE who are ART-naïve and who plan to follow-up at YRG CARE
* Speaks Tamil, Telugu, or English

Exclusion Criteria:

* Previous ART exposure
* Not competent to provide informed consent or participate in the study
Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV

The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.

Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10\^7 cells；2) medium-dose group: 100mL with 5.0×10\^7 cells；3) high-dose group: 100mL with 1.0×10\^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 (including 18 and 65), regardless of gender;
* Decompensated stage of viral hepatitis B cirrhosis;
* The effect of conventional medical treatment is not good, and the condition is repeated;
* ALB \< 35g/L, TBIL \< 170μmol/L, INR \> 30%, Child-pugh score ≥7; MELD score ≤15;
* Hgb \> 70g/L, PLT \> 3×109/L;
* Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.

Exclusion Criteria:

* With spontaneous peritonitis or other serious infection;
* Patients with hepatorenal syndrome;
* Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month;
* Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
* blood and endocrine system;
* HIV positive;
* Positive autoantibodies related to autoimmune liver disease;
* Presence of liver or any type of malignant tumor;
* Pregnant women, breast-feeding women or those with recent birth plans;
* Those who have a history of alcohol and drug abuse and failed to get rid of it effectively;
* Participated in other clinical trials within 3 months prior to enrollment;
* Participated in clinical research on stem cells;
* Unwillingness to sign informed consent;
* Other conditions that the investigator considers inappropriate for patients to participate in this study.