cyrilzakka/clinical-trials huggingface dataset:
Comparative Effectiveness of Two Initial Combination Therapies in Patients With Recent Onset Diabetes

The primary purpose of this study is to evaluate the efficacy, durability, and mechanism of HbA1c reduction produced by the combination of pioglitazone plus tirzepatide compared to metformin plus sitagliptin in patients with recently diagnosed type 2 diabetes mellitus.

This is a randomized open label controlled 2 arm study (with one of the arms containing 3 sub-groups) which aims to examine the effectiveness and long term effects on HbA1c reduction produced by the combination of pioglitazone plus tirzepatide versus metformin plus sitagliptin in recently diagnosed type 2 diabetes mellitus (T2DM) patients.

A subgroup of patients from group 1 will be invited to participate in a sub-study which lasts for 6 months and aims at exploring the metabolic/molecular mechanisms responsible for the study results. The selection of subjects to each subgroup will be done randomly and the end of sub-study, subjects will continue therapy and follow-up from month 6 on in the main study.

Eligibility Criteria:
Inclusion Criteria:

1. Ability of subject to understand and the willingness to sign a written informed consent document.
2. Males and females; Age 18-75 years
3. Recently (within 5 years) diagnosed Type 2 Diabetes Mellitus (T2DM) patients
4. Drug naïve or receiving metformin monotherapy
5. HbA1c \>6.5% (no limit on upper HbA1c value);
6. Willingness to adhere to the investigational product regimen
7. Good general health
8. Stable body weight over the preceding 3 months
9. Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

1. positive anti-GAD (antibodies to glutamic acid decarboxylase)
2. pregnancy or plan of becoming pregnant
3. evidence of proliferative diabetic retinopathy,
4. plasma creatinine \>1.4 females or \>1.5 males;
5. presence of congestive heart failure (CHF);
6. history of cancer (\<5 years);
7. prior history of pancreatitis,
8. bladder cancer or family history of thyroid tumors;
9. presence of hematuria in the urine analysis.
Pain Inhibition and Facilitation in Recurrent Low Back Pain

This study evaluates psychophysical measures of pain inhibition and facilitation, along with cortical responses to different sensory stimuli, in patients with recurrent low back pain and matched healthy individuals.

Pain inhibitory and facilitatory mechanisms have been suggested to play a role in the development of persistent low back pain; however, there is still debate on when changes in these mechanisms occur. Similarly, evoked cortical responses can reflect neuroplastic changes in pain processing regions, which are also thought to play a role in the transition to persistent pain, but there is also debate on when these neuroplastic changes develop relative to low back pain. Therefore, this study will use patients with an intermediary clinical pain state, recurrent low back pain, and matched healthy control participants, to investigate within and between subject differences in pain inhibitory, facilitatory and neuroplastic mechanisms.

Eligibility Criteria:
Inclusion:

* Healthy men and women
* Aged 18-60 years
* No previous back pain OR \>1 previous episode of low back pain in past 12 months
* No current back pain OR Pain in the region posteriorly between the inferior border of the 12th rib and the lower gluteal fold (low back pain) at time of recruitment lasting \>24 hours
* Able to speak, read and understand English

Exclusion:

* Pregnancy
* First episode of low back pain
* Low back pain associated with menstruation
* Chronic low back pain (continuous pain episode for \>3 months)
* Currently seeking active treatment for low back pain
* Red flags symptoms
* Drug addiction defined as the use of cannabis, opioids or other drugs
* Current or previous neurologic, musculoskeletal, mental, or other illnesses which may affect the trial
* Current or previous chronic or recurrent pain condition other than low back pain
* Current regular use of analgesic or other medication which may affect the trial
* Lack of ability to cooperate
* Recent history of acute pain particularly in the lower limbs (unless related to LBP)
* Abnormally disrupted sleep in 24 hours preceding experiment
Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults

Assess the impact of 100% grape juice on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Investigators earlier clinical work and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on appetite and glycemia. Investigators aim to better understand the use of 100% grape juice modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25.0-34.9 kg/m2
* Willingness to eat all test foods
* Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day.
* Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)

Exclusion Criteria:

* Taking medications known to affect glycemia, lipid metabolism or appetite
* Body weight fluctuation of \>5kg in the past 3 months
* Taking vitamin or other supplements
* Smokers
* Acute or Chronic disease
Dynamic Surface Exercise and Trunk Targeted Training in Children With Spastic Cerebral Palsy

This study aims to describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years

Cerebral palsy (CP) is a well-documented nonprogressive neurodevelopmental condition commencing in early childhood and persisting throughout life. The neuromuscular deficits observed in children with CP include abnormal muscle tone that affects posture, movement, alteration of balance and motor coordination, decrease in strength, and loss of selective motor control, leading to functional limitation. Neurodevelopmental principles state that the control of movement proceeds from the proximal to the distal part of the body. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Using dynamic surface for exercise provides proprioceptive and vestibular feedback about the position of their body segments in space with adaptive motor control response to stimuli. Standard physiotherapy based on motor-learning principle is task-specific training, which involves practice of functional movements in activities of daily living.

This study aims to describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years. Data will be taken from shahida islam teaching hospital Lodhran after taking consent, techniques will be applied and data will be recorded. Assessment will be made by using pedriatics balance scale , gross motor function measure (GMFM 66) and trunk control measurement scale (TCMS) for determining balance and gross motor function and trunk stability . The collective data will be analyzed in Statistical Package for Social Sciences (SPSS) 27.0

Eligibility Criteria:
Inclusion Criteria:

Children who can follow the therapist instructions

* Children who have not had any procedure and surgery within the past six months
* Both genders male and female
* Age 5 to 10 years
* Spastic cerebral palsy

Exclusion Criteria:

* Children with innate musculoskeletal diseases, developing Central nervous system diseases and history of orthopedic surgery

  * Children with genetic disorders and other severe diseases other than cerebral palsy
  * Children who had Botulinum Toxin A (BoNT-A) injection during the last 6 months or had seizures during the last one year were excluded from the study
  * Children with visual impairement
  * Children with hearing Impairemen
Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia

This study investigated the effectiveness and safety of SoracteLite ™- Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic Benign Prostatic Hyperplasia (BPH) at 6 and 12 months follow-up

The purpose of this study was to investigate the effectiveness and safety of SoracteLite ™ - Trans-Perineal Laser ablation (TPLA) in the treatment of patients with symptomatic benign prostatic hyperplasia (BPH) at 6 and 12 months follow-up. Methods: Patients with urinary symptoms secondary to BPH underwent TPLA under local anaesthesia in four centers. Under US guidance, up to four 21G applicators were inserted in the prostatic tissue. Each treatment was performed with diode laser operating at 1064 nm changing the illumination time according to prostate size.

Eligibility Criteria:
Inclusion Criteria:

* Male
* ≥ 50 years of age
* International Prostate Symptoms (IPSS) ≥12
* Peak urinary flow rate (Qmax): \<15 ml
* Prostate volume: ≥ 30 ml, measured by transrectal ultrasound
* Post-void residual (PVR): \<400 ml
* Signed informed consent

Exclusion Criteria:

* MRI signs of malignancy confirmed by biopsy investigation
* urethral stenosis
* serious coagulation disorders
* inadequate compliance
* ischemic pathology in the previous six months
* active phase inflammatory pathology
Optimal Positioning of Nasopharyngeal Temperature Probes: A Prospective Cohort Study

Low body temperature (hypothermia) is often observed in anesthetized patients. Mild hypothermia increases complications such as surgical blood loss, postanesthesia recovery and the duration of hospitalization. To assess body temperature and minimize hypothermia-related complications, it is important to have accurate and reliable methods of measuring intraoperative core temperature. Common practice is to insert a nasopharyngeal (back of the throat from the nose) probe through one of the nostrils. However, there is no consensus or guideline regarding how deep the nasopharyngeal probe needs to be inserted. This study is being done to determine the insertion depth (or range of depths) that best approximates core temperature, which is temperature of the vital organs, e.g. heart, liver and lungs.

Participation in the trial will occur on the day of surgery. The subject will be asked to breathe through one nostril and then the other before receiving anesthesia. The less congested nostril will be selected for study. If there is no difference, then the investigator will use the right nostril.

Once under anesthesia, an esophageal temperature probe will be inserted to serve as a reference core temperature, which is used routinely in surgery. Then the nasopharyngeal probe will be inserted into the nostril.

Both nasopharyngeal and esophageal temperatures will initially be recorded 45 minutes after anesthetic induction. The nasopharyngeal probe will then be withdrawn 2 cm and after a 3-minute equilibration period, nasopharyngeal and esophageal temperatures will again be recorded. The nasopharyngeal probe withdrawal sequence will be repeated, 2 cm at a time, until only 2 cm remains in the nostril. There will be a total of 10 sets of nasopharyngeal and esophageal temperatures obtained.


Eligibility Criteria:
Inclusion Criteria:

* elective non-cardiac surgery scheduled to last at least 1.5 hours
* supine position anticipated
* general anesthesia with ETT

Exclusion Criteria:

* nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned surgery in the region
* history of recent substantive epistaxis
* history of bleeding disorders
* therapeutic-dose anti-coagulation (aspirin and DVT prophylaxis permitted)
* contraindications to esophageal temperature probe insertion (e.g. known varices)
Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia

Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.

CAR-T has stronger effect of anti-tumor capacity. While people have been able to control the clinical complications now, so conducting CAR-T clinical trials has a strong demand and value. This study aims to evaluate the safety and efficacy of CD19-CART in treating refractory or recurrent ALL.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
* Refractory or relapsed B cell-acute lymphoblastic leukemia
* No available curative treatment options (such as hematopoietic stem cell transplantation)
* Stage III-IV disease
* Creatinine \< 2.5 mg/dl
* Aspartate transaminase-alanine transaminase ratio \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Karnofsky performance status \>= 60
* Expected survival time \> 3 months
* Adequate venous access for apheresis
* Ability to understand and provide informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Patients requiring T cell immunosuppressive therapy
* Active central nervous system leukemia
* Any concurrent active malignancies
* Patients with a history of a seizure disorder or cardiac disorder
* Patients with human immunodeficiency virus, hepatitis B or C infection
* Uncontrolled active infection
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device

The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.

The study is a prospective, multi-center, single arm, clinical study to evaluate the safety and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate of complete angiographic occlusion at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
* Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
* Subject is willing to comply with specified follow-up evaluation

Exclusion Criteria:

* Planned staged procedure
* Currently enrolled in another investigational device or drug study
* Target aneurysm that has been previously treated
* Mycotic, fusiform or dissecting aneurysm
* Admission platelet \<50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR \>3.0
* A serum creatinine level \> 2.5 mg/dL within 7 days prior to index procedure
Study Of Right Ventricular Performance In PAH Patients Treated With Rapid Dose Treprostinil (Remodulin)

Patients with pulmonary arterial hypertension (PAH) are at much higher risk of death if the RV (right ventricle) is weak. The purpose of this study is to get a better understanding of the factors that determine RV adaptation and how the RV compensates on therapy. The investigator is also interested in how Remodulin (treprostinil) infused over a short period (approximately 48-72 hours) affects the patient's quality of life, medical care, and personal health behaviors.

Treprostinil, also known as Remodulin, has been approved by the US Food and Drug Administration for use in the treatment of PAH. The investigator has been treating patients with Remodulin by rapid infusion (over 48 hours) for over 6 years. The investigator would like to establish this practice as safe and effective for the benefit of other centers that treat PAH.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically suspected World Health Organization (WHO) group I PAH
* Patients with New York Heart Association/WHO functional class II-IV
* Patients with mean pulmonary artery pressure \>25 mmHg, pulmonary capillary wedge pressure \</=15 mmHg, and pulmonary vascular resistance \>3 wood units
* Age \>18 and \<80
* No evidence of active ischemic heart disease

Exclusion Criteria:

* Left ventricular ejection fraction \<50%
* Patients with significant restrictive lung disease (FVC \<60% predicted) and/or significant obstructive lung disease (FEV1 \<55% predicted) within 1 year of enrollment if pulmonary function testing is available
* Patients with significant, investigator-determined parenchymal lung disease on chest x-ray or CT of the chest
* History of pulmonary embolism within the last three months or chronic pulmonary embolism
* Poorly interpretable grey scale echocardiographic images
* Contraindications to right heart catheterization
* Moderate-severe aortic and mitral valve abnormality
* Active or previous use of pulmonary vasoactive medication within the previous 12 weeks
* Renal failure with serum creatinine clearance \<30 ml/hr
* High-probability ventilation-perfusion scan
Morbidity, Mortality And Risk Factors of Mpox in HIV Negative High Risk Sexual Health Clinic Attenders and People Living With HIV

This data collection study aims to describe and compare the outcomes of Mpox on people living with HIV (PLHIV) and HIV-negative individuals who are on pre-exposure prophylaxis (PrEP). The study also aims to identify risk factors for specific Mpox outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MPX was more than 90 days prior to data collection
* Confirmed MPX infection by documented PCR testing of lesions between 1st May 2022 to 1st December 2023
* At least 18 years of age
* Cases (PLWHIV + MPX) i) Documented HIV-1 infection
* Cases (PrEP users + MPX) i) Attended a clinic to receive PrEP

Exclusion Criteria:

* MPX diagnosed based on clinical criteria only
* MPX diagnosis was within the last 90 days
The Role of Personal Identity in Psychotic Symptoms: a Study With the Repertory Grid Technique

Personal identity is being recently recognized as a core element for mental health disorders, with relevant clinical implications. However, scarcity of data exists on its role in schizophrenia and related disorders. The repertory grid (RGT), a technique derived from personal construct theory, has been used in different clinical and non-clinical contexts for the study of the construction perception of self and others, to appreciate aspects of interpersonal construing such as polarization and differentiation (unidimensional thinking) or self-construction.and Our study aims to explore the potential influence of the structure of personal identity and of other relevant cognitive factors (social cognition, metacognition, neurocognition) in positive and negative symptoms in people suffering schizophrenia and related disorders.

Over recent years, the importance of the sense of self and personal identity in psychopathology and its treatment has been highlighted. Several studies inspired in the Personal Construct Psychology framework have found a variety of identity characteristics in clinical conditions such as depression or eating disorders, but the evidence in schizophrenia and other psychotic related disorders is scarce.

In addition, current psychological models of positive and negative symptoms highlight the influence of neurocognition, social cognition and self-concepts in the development and maintenance of psychotic experiences. Despite the recognized need of person-centered approaches to understand psychopathology processes in psychosis, psychological models for explaining psychotic symptoms have not explored sufficiently the role of this kind of person-centered measures.

Aim

1. To examine the influence of the structure of personal identity and other relevant cognitive factors in positive and negative symptoms

Hypotheses

1. Positive symptoms will be influenced by dichotomous thinking style and construction of self as measured with the RGT.
2. Negative symptoms will be affected by the richness of the construct system as measured with the RGT.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia, psychotic disorder not otherwise specified, delusional disorder, schizoaffective disorder, brief psychotic disorder, or schizophreniform disorder
* age between 18 and 60 years.
* patients from outpatient mental health units

Exclusion Criteria:

* traumatic brain injury, dementia, or intellectual disability (pre-morbid IQ \<70)
* current substance dependence
Phase I Study of LXH254 in Patients With Advanced Solid Tumors Haboring MAPK Pathway Alterations

A Phase I Study of LXH254 in Patients With Advanced Solid Tumors That Harbor MAPK Pathway Alterations.


Eligibility Criteria:
Inclusion Criteria:

* All patients participating in this clinical trial must have progressed following standard therapy, or for whom, in the opinion of the Investigator, no effective standard therapy exists, is tolerated or appropriate.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
* Presence of at least one measurable lesion according to RECIST v1.1.
* Documented MAPK alteration

Additional inclusion criteria for the Dose Expansion part: LXH254 in combination with PDR001:

* Patients with confirmed KRAS-mutated NSCLC
* Patients with confirmed NRAS-mutated melanoma (cutaneous melanoma only)

Exclusion Criteria:

- Prior treatment with a BRAFi, MEKi and/or pan-RAF inihibitors for patients to be enrolled in the dose expansion part.

Exceptions may be made after documented agreement between Novartis and Investigator.

* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.
* Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Patients receiving proton pump inhibitors which cannot be discontinued 3 days prior to the start study treatment and for the duration of the study.
* Pregnant or nursing (lactating) women

Additional exclusion criteria for LXH254 in combination with PDR001

* History of severe hypersensitivity reactions, which in the opinion of the investigator may cause in increased risk of serious infusion reaction.
* Known human immunodeficiency virus (HIV).
* Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
* Active, known or suspected autoimmune disease.
* Active infection requiring systemic antibiotic therapy
* Patients requiring systemic steroid therapy or any immunosuppressive therapy (≥10mg/day prednisone or equivalent) which cannot be discontinued at least 7 days prior to first dose of study treatment.
* Use of any live vaccines against infectious diseases within 4 weeks of initiation of study treatment.

Other inclusion/exclusion criteria as per protocol may apply.