cyrilzakka/clinical-trials huggingface dataset:
The Detection of Chronic Obstructive Pulmonary Disease in Patients With Diabetes Mellitus

"Background: Chronic obstructive pulmonary disease (COPD) is an ongoing lung condition caused by damage to the lungs. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. Diabetes can worsen the progression and prognosis of COPD.

If inflammation cause in lungs breathing process become disturbed. If damages the air sacs (alveoli) that cause emphysema. COPD mainly starts with asymptomatic patients who do not realize that they have it. It mostly affects older people or middle-aged. Its symptoms become develop slowly but with the time they become worsen, patient change their life style and treatment become helpful to prevent from chronic disease The Detection of Chronic Obstructive Pulmonary Disease in Patients with Diabetes Mellitus.

Methods: The Study design was cross sectional and carried out in hospital, Lahore from July 2024 to Jan 2024. All eligible patients who were Diabetes Mellitus in the study through random sampling technique.

Eligibility Criteria:
Inclusion Criteria:

* Age: 30-65 years Gender: Both
* Male and female
* At least 5-10 year history of Diabetes Mellitus
* Chronic Obstructive Pulmonary Disease

Exclusion Criteria:

* Patients who smoke prolong.
* Patient having other diseased (asthma, lung carcinoma).
* Patients having Acute Respiratory Distress Syndrome (ARDS)."
One Sequencing Find All for Helicobacter Pylori Infection

The aim of this study is to Identify antibiotic resistance gene mutations in Helicobacter pylori (HP) and genetic diversity of drug metabolism for antibiotics and proton pump inhibitors (PPIs) in patients with HP infection using next-generation sequencing (NGS). The mutation of host/HP strain will be investigated by single NGS, and the eradication results according to genetic polymorphism of host/HP strain will be analyzed.

This study is a prospective observational study for the Helicobacter pylori (HP) infected patients on typical gastroduodenoscopy (EGD) at Boramae Hospital, Seoul, Korea.

The presence of antibiotic resistance genes of HP and the diversity of the pharmacokinetic genotypes of the subjects will be investigated by performing single next-generation sequencing (NGS) analysis using gastric mucosal tissue samples of the HP infected subjects.

The purpose of this study is to collect data on the antimicrobial resistance mutation of HP (23S rRNA gene, pbp1 gene, rdxA, frxA, frxB gene, 16S rRNA, gyrA, gyrB gene, and Cag A gene) and to investigate the genetic diversity on the metabolism of antibiotics and proton pump inhibitors (CYP enzyme) in a Korean population.

The investigators are going to compare the results of standard eradication therapy according to the resistance mutation of HP and drug genetic diversity of subjects.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* CLO test positive
* Findings of gastric ulcer, atrophic gastritis on gastroduodenoscopy
* Agreed to HP eradication therapy and accept to follow-up
* Agreed to participating in the study

Exclusion Criteria:

* History of previous HP eradication treatment
* History of partial gastrectomy
Development of Clinical Method to Triclosan Retention in Plaque Following Brushing

The objective is to develop a method to determine active ingredient uptake in oral care products.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteer 18 - 65 years of age (inclusive).
* Good general health with a minimum of twenty (20) natural, uncrowned teeth (excluding third molars)
* Able and willing to sign the informed consent form.
* Plaque score of at least 1.5 on the modified Quigley-Hein plaque index.
* No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental procedures/visits
* Medical condition which precludes not eating/drinking for 2 hours
* Advanced periodontal disease (gum disease)
* 5 or more decayed, untreated dental sites (cavities)
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of drugs that can affect salivary flow
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn, etc)
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

A randomized phase II trial of FOLFOXIRI in Combination With GM-CSF and IL-2 (FOLFOXIGIL) Versus FOLFOXIRI as First-line Treatment for Patients With Metastatic Colorectal Cancer.

The triple drug regimen FOLFOXIRI (irinotecan, oxaliplatin, fluorouracil, and folinate) for the first-line treatment of metastatic colorectal cancer has shown a significant increase in response rate and overall survival compared to FOLFIRI and FOLFOX. The combination of GOLF chemotherapy with GM-CSF and IL-2（GOLFIG regimen） has shown more active than the standard FOLFOX chemotherapy in first-line mCRC patients，through the chemoimmunomodulatory effects. SO the FOLFOXIGIL chemoimmunotherapy regimen was designed with the same principle to evaluate the antitumor frontline efficacy in comparison with the FOLFOXIRI regimen as first-line treatment of mCRC patients. This is a multicenter, randomized controlled, double-blind, phase II trial.

Eligibility Criteria:
Inclusion Criteria:

* histological or cytological documentation of adenocarcinoma of the colon or rectum.
* unresectable metastatic disease
* age 18 to 75 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower if age 70 years or younger or ECOG performance status of 0 if age 71 to 75 years
* at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.
* no previous chemotherapy or target therapy for metastatic disease (adjuvant chemotherapy for non-metastatic disease is allowed if terminated more than 6 months ago).
* adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:

  * Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥9g/ dL.
  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN).
  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
  * Alkaline phosphatase limit ≤ 5x ULN.
  * Amylase and lipase ≤ 1.5 x the ULN.
  * Serum creatinine ≤ 1.5 x the ULN.
  * Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.

Exclusion Criteria:

* previous palliative chemotherapy for metastatic disease
* previous chemotherapy including irinotecan or oxaliplatin
* symptomatic cardiac disease, myocardial infarction in the last 24 months or uncontrolled arrhythmia
* active infections
* pregnancy or lactation at the time of study entry.
* inflammatory bowel disease
* major autoimmune diseases
* acquired immunosuppression (AIDS or major immunosuppressive agents)
Cardiovascular Health Promotion Among African-Americans by FAITH!

Given the importance of healthy lifestyle practices to cardiovascular disease (CVD) prevention and the utility of church-based interventions in African-American adults, the investigators developed a theory-informed, strategically-planned, health and wellness intervention with Rochester, Minnesota (MN) and Twin Cities area (Minneapolis, St. Paul, MN) churches with predominately African-American congregations. The objective of the study was to partner with churches to implement a multi-component, health education program through the use of core educational sessions delivered through a digital-application accessible on demand via interactive access on computer tablets and the Internet. The overarching goal was to increase the awareness and critical importance of healthy lifestyles for CVD prevention and provide support for behavior change.


Eligibility Criteria:
Inclusion Criteria:

* Basic Internet navigation skills, at least weekly Internet access, active email address, minimal fruit/vegetable intake (\<5 servings/day), no regular physical activity program (\< 30 minutes/d of moderate physical activity), able to engage in moderate physical activity (no restrictions)

Exclusion Criteria:

* Diagnosis of a serious medical condition or disability that would make participation difficult (i.e. visual or hearing impairment, mental disability that would preclude independent use of the app)
Comparison of Hemodynamic Changes With Morphine Versus Esmolol During Induction of Anaesthesia

Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia

Comparing hemodynamic profile of patients during induction of General Anesthesia with intravenous morphine as an adjuvant drug versus Intravenous esmolol as an adjuvant agent,My aim is to study which drug has superior hemodynamic profile in terms of hemodynamic stability of patient requiring General Anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* ASA 2 patients presenting for elective surgery.

Exclusion Criteria:

* Patients having major cardiac disease.
* Metastatic disease.
* Pregnant females.
* Those unwilling to be part of study.
Trehalose Administration in Subjects With Spastic Paraplegia 11 (3AL-SPG11)

Hereditary spastic paraparesis type 11 (SPG11) is caused by mutations in the SPG11 gene that produces spatacsin, a protein involved in lysosomal function.

Several experiments on subjects affected by neurodegenerative diseases with dysfunction of the autophagic-lysosomal system show that trehalose improves the pathological phenotype. This evidence indicates that trehalose could be used in patients with SPG11 to try to prevent the accumulation of glycosphingolipids at the lysosomal level and induce the genesis of new lysosomes. This study aims to record clinical data of 20 patients with SPG11 who take trehalose during 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of SPG11
* Written signed informed consent

Exclusion Criteria:

* Diagnosis of other concomitant neurodegenerative diseases
* taking other experimental drugs within 30 days of the first Study visit (T0) and during the study
* Refusal to sign informed consent
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

The purpose of this study is to investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.


Eligibility Criteria:
Main Inclusion Criteria:

* Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.
* Have a treatment history of an inadequate ADT response to at least 1 ADT (but not \> 3) for the current episode.
* Have received a single, trial-approved, SSRI or SNRI at an adequate dose for

  ≥ 6 weeks prior to screening.
* Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
* Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
* Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.

Main Exclusion Criteria:

Subjects with any of the following current Axis I DSM-IV-TR diagnoses:

* delirium
* dementia
* amnestic
* other cognitive disorders
* schizophrenia
* schizoaffective disorder
* other psychotic disorders
* bipolar I disorder,
* bipolar II disorder
* bipolar disorder not otherwise specified (NOS)
* eating disorders
* anorexia nervosa
* bulimia
* obsessive compulsive disorder
* post-traumatic stress disorder

Subjects with any of the following current Axis II DSM-IV-TR diagnoses:

* borderline, antisocial
* paranoid
* schizoid
* schizotypal
* histrionic personality disorders
* mental retardation.
Biomarkers NGAL, IL 18 as Predictors of Acute Kidney Injury in Renal Transplant Recipients

New markers of AKI including plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) and Interleukin 18(IL-18) may form a biomarker panel that may help predict AKI earlier in the course of disease than creatinine.

Biomarkers for renal injury decreases following successful Renal transplantation. The level of decrease in biomarkers, correlates with the renal graft function, and this fall occurs earlier than the fall in creatinine and/or increase in the Urine output. Should graft dysfunction occurs, investigating the fall in biomarkers could provide a window of opportunity for therapeutic interventions and also guide in evaluating the effectiveness of such interventions. NGAL is a 25 kilo Dalton(kDa) ligand-binding protein of the lipocalin family, present in human tissues including kidney. NGAL is induced early in ischemic or nephrotoxic injury to the kidney. It has also been evaluated as a biomarker of acute injury in kidney transplantation. Interleukin (IL)-18 is synthesized as an inactive 23 kDa precursor by several tissues including monocytes, macrophages, and proximal tubular epithelial cells. Urine IL-18 is elevated in patients with acute tubular necrosis and in urinary tract infection, chronic renal insufficiency, and prerenal azotemia.

Delayed graft function and slow graft function are associated with poor graft survival at one year. Early prediction of graft dysfunction could help prognosticate and initiate renoprotective measures. Urine biomarkers including NGAL and IL 18 have shown promise in this regard, but it may be fraught with risk of biomarker dilution, an effect of urinary flow rate on biomarker levels. The investigators hypothesized that plasma NGAL and plasma IL-18 can detect reduced renal graft function in renal transplant recipients within the first 2 postoperative days.

Creatinine is widely used as a marker of kidney function. The use of Creatinine has many confounding factors, and it rises only after loss of 50% of renal function. This time lost in rise of serum creatinine gives rise to the risk of missing time window that may be used to prevent progress of Acute Kidney Injury (AKI).

NGAL and IL 18 are a panel of new biomarkers associated with acute kidney injury, and their levels correlate with an improvement of graft function in renal transplant recipients. Precise and early detection of a failing graft can prompt multiple investigations and interventions which may ultimately aid in maintaining the graft.

The serum levels were measured to avoid the dilution effect and output variability of urine samples.

The investigators measure the serum NGAL and IL-18 for the first 2 post-operative days after renal transplantation, and check if the trends correlate with long term graft survival and function.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing renal transplant surgery

Exclusion Criteria:

* Patients with sepsis
* Patients diagnosed with malignancy
* Patients on immunosuppressants for other indications
* Denial to participation
* Patients undergoing re-transplantation
* Pregnant Women
Transcranial Magnetic Stimulation for Treatment of Methamphetamine Dependence

Repetitive transcranial magnetic stimulation (rTMS) was used to treat methamphetamine (MA) addiction in previous studies, while the evidence-based protocols still required. The aim of this research is to evaluating the effectiveness and safety of rTMS treatment in improving the days of abstinence maintenance. In addition, treatment effect on cognitive impairment, psychological craving and depression are also evaluated during the study.

First, a multicenter, double-blind, randomized control study is going to be carried out. 100 recruited patients will be randomized assigned to the intervention group and the control group, receiving either 4-week of repetitive transcranial magnetic stimulation (rTMS) treatment or 4-week of sham rTMS treatment. Both groups will receive 12-week urine drug test follow-up (1 time per week). Negative rate of urine test during the follow-up period is set as primary outcome. Cognitive function, craving, depression are also evaluated before and after the intervention.

Secondly, another 40 patients will be recruited from these 100 patients (20 subjects each group). Magnetic resonance spectroscopy (MRS) test is applied to investigate the potential neurobiological mechanism of rTMS treatment. This study will be very helpful to develop an evidence-based rTMS treatment protocols for MA dependent patients and decrease risk of relapse for both the patients and their families.

Eligibility Criteria:
Inclusion Criteria:

1. In accordance with the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) for methamphetamine (MA) use disorders
2. Junior high school degree or above
3. Normal vision and hearing
4. Dextromanual
5. Less than one month before last drug use

Exclusion Criteria:

1. Have a disease that affect cognitive function such as history of head injury, cerebrovascular disease, epilepsy, etc
2. Have cognitive-promoting drugs in the last 6 months
3. Other substance abuse or dependence in recent five years (except nicotine)
4. Mental impairment, Intelligence Quotient (IQ) \< 70
5. Mental disorders
6. Physical disease
Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Pain associated with UL impairment due to multifactorial causes is a frequent symptom in patients with stroke. Occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (SD) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. At present, positioning principles of the hemiplegic shoulder exist in clinical practice. These are aimed at prevention of pain associated with UL Impairment; however there is no clear consensus among professionals of particular SD that should be implemented for adults with stroke

Eligibility Criteria:
Inclusion Criteria:

* Having suffered in the last 6 months maximum a first stroke responsible for hemiplegia.
* Finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf.
* Boston Diagnostic Aphasia Examination (BDAE) \> 3.
* Consent of the patient
* Patient affiliated or benefiting from a social security scheme

Exclusion Criteria:

* Stroke recurrence, or stroke more than 6 months-old
* Patient already wearing a coaptation scarf
* Presence of lymphoedema, venous thrombosis of the upper limb
* Neoprene allergy
* Severe cognitive impairment: Mini-Mental State (MMS) \<15
* Patient being part of another care protocol
* Adult under the protection of justice, tutors or curators
* Pregnant or lactating woman.
Angelman Syndrome (AS) Biomarker Study

The primary objective of this study is to measure ubiquitin-protein ligase E3A (UBE3A) protein levels in cerebrospinal fluid (CSF) and to evaluate its utility as a biomarker in support of the development of therapies for AS.


Eligibility Criteria:
Key Inclusion Criteria:

* Ability of the participant's legally authorized representative (LAR) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local privacy regulations
* Must have genetically confirmed diagnosis of AS (UBE3A deletion, UBE3A mutation, paternal uniparental disomy, or imprinting center defect) or dup15q syndrome (with number and size of duplications of 15q specified) provided by the Investigator
* Must be scheduled for a procedure unrelated to the study that will involve administration of general anesthesia or conscious sedation.

Key Exclusion Criteria:

* Lumbar Puncture (LP) procedure less than 30 days before the Sampling Visit
* Any contraindications to having an LP
* The blood and CSF collection will, in the opinion of the Investigator, inhibit, in some way, the prescheduled procedure that requires anesthesia or sedation
* Current enrollment or past enrollment in an interventional clinical study in which an investigational gene therapy or antisense oligonucleotide (ASO) is/was administered
* Enrollment in an interventional clinical study in which an investigational small molecule/antibody treatment or approved small molecule/antibody therapy is administered within 1 month (or 5 half-lives of study agent, whichever is longer) prior to the Sampling Visit which, under the judgement of the Investigator and/or Sponsor would affect UBE3A and other CSF biomarker levels. Use of approved or investigational small molecule therapies which would not impact the biomarkers above will be eligible with Sponsor approval prior to enrollment (e.g., anti-epileptic drugs being studied in alternative formulation, other derivatives of benzodiazepines, or other same class drugs as those already permitted as part of the study).

Note: Other protocol defined inclusion/exclusion criteria may apply.