cyrilzakka/clinical-trials huggingface dataset:
GH21 Combined With D-1553 in KRAS G12C Mutant Advanced Solid Tumors

This s a multi-center, open-label phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of GH21 combined with D-1553 in patients with advanced or metastatic solid tumors harboring KRAS G12C mutation.

This study includes 2 parts: dose escalation(Phase Ib) and dose expansion (Phase II). The objective of the dose escalation part is to evaluate the safety, tolerability and pharmacokinetics of GH21 in combination with D-1553 in patients with advanced solid tumors harboring KRAS G12C mutation and to determine the RP2D for the combination therapy. In the dose expansion part, preliminary efficacy and safety of the combination therapy at the RP2D will be further explored in patients with specific cancer harboring KRAS G12C mutation.

Eligibility Criteria:
Inclusion Criteria:

* The patient or his legal representative is able to understand and voluntarily sign a written informed consent (before commencing this study and any research procedure);
* Age ≥18 years old, male or female;
* KRAS G12C mutant advanced solid tumor;
* ECOG Performance Status of 0 or 1
* At least one measurable lesion as defined by RECIST 1.1

Exclusion Criteria:

* acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, cerebrovascular accident, or transient ischemic attack within 6 months before first administration; Grade III-IV heart failure based on the New York Heart Association Cardiac Function Scale at screening; During screening, echocardiography (ECHO) showed left ventricular ejection fraction (LVEF) ≤50%;
* Patients who have a history of severe allergy, or have a history of allergy to the experimental drug/any excipient/combination drug, or have a history of allergy to multiple drugs;
* There is an active infection (≥ grade 2) requiring anti-infective treatment or an unexplained fever exceeding 38 ° C within 28 days before the first dose;
* Any toxicity from previous antitumor therapy prior to initial administration has not returned to CTCAE 5.0 rating ≤ Class 1 (unless hair loss, grade 2 peripheral neuropathy, and/or other grade ≤2 adverse events that do not pose a safety risk);
* Pregnant and lactating women;
* The investigator considers that there are any clinical or laboratory abnormalities or other reasons to be unsuitable for participating in this clinical study.
The Effect of Deferasirox on Response Rate of Acute Leukemia Patients Not Treated by Standard Chemotherapy Regimens

The purpose of this study is to determine whether deferasirox is effective in the treatment of acute lymphatic leukemia (ALL) and acute Myeloid leukemia (AML).

Many studies have demonstrated that Iron is essential for the metabolism, cell cycle regulation and metastasis in different cancer cell lines. It is also believed that Iron concentration will increase in cancer cells by enhancing expression of TFR-1 receptors and in case of receptor saturation, non-receptor-mediated pinocytosis would be a significant pathway for more iron intake. Iron deficiency may lead to increase P 53 which consequently will stop cell mitosis in G1-S state. It also increases expression of N-myc down-regulated gene 1 which can suppress metastasis in cancer. It has been suggested that Iron chelators may decrease leukemic tumor growth in animal models of acute myeloid leukemia (AML). Some other case studies demonstrated the role of Iron chelators in relapse and/or refractory AML. Finally a phase 1 clinical study is undertaken for evaluate the role of Tiapine and cytarabine for adult AML and high-risk myelodysplastic syndrome. So in this study the investigators try to evaluate the role of iron chelating agent (deferasirox) for patients with acute lymphatic leukemia (ALL) and AML patients who cannot be treated with standard chemotherapy regimes .

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute leukemia (myeloid or lymphoblastic) who do not receive the standard chemotherapy regimens for treatment; because of the following reasons:

1. age \> 65
2. existence of another illness, such as heart failure (EF\> 40)

2. Ferritin \< 500 μg / l

3. Not existence of other co morbidity

4. GFR \> 40

Exclusion Criteria:

1. GFR \< 40
2. Control group become iron overloaded (Ferritin \> 500 μg /l)
3. Incidence of any severe gastrointestinal symptoms (Mucositis, Enterocolitis, Typhlitis, Nausea, Diarrhea)
4. Not willing to continue treatment.
Psychiatric and Cognitive Manifestations of Parkinson's Disease

Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most patients also experience psychiatric and cognitive symptoms, sometimes from the disease itself, and sometimes as a side-effect of PD medications. The goals of this study are to evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms in PD.

Parkinson's Disease (PD) is defined by the presence of motor symptoms, but in recent years there has been increasing recognition of non-motor manifestations, including anxiety, depression, and cognitive symptoms. In addition, PD medications have been shown to cause impulse control disorders, cognitive changes, and non-motor withdrawal symptoms (dopamine agonist withdrawal syndrome) when they are discontinued. The goals of this study are to test the hypothesis that the presence of psychiatric and cognitive symptoms are associated with greater self-perceived disability (out of proportion to objective deficits), increased utilization of healthcare resources, and decreased quality of life. In addition, we will examine the clinical correlates of these psychiatric symptoms. To test these hypotheses, we will screen PD patients for anxiety, depression, impulse control disorders, and dopamine agonist withdrawal syndrome, and compare cases and controls with regard to demographic characteristics, motor features of PD, disability, healthcare utilization, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's Disease (or healthy control subject)
* Age \>=21 and \<=99
* Capacity to provide informed consent
* Ability to complete the questionnaires

Exclusion Criteria:

* Clinical diagnosis of dementia
* Terminal illness (life expectancy \< 12 months)
* Presence of a neurodegenerative disorder other than Parkinson's Disease
Effect of Auto-Bolus Interval on Analgesic Quality During Labor Analgesia With Dural Puncture Epidural

It is aimed in this study to compare the effect of changing the interval time for programmed auto boluses of local anaesthetics on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

This study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at Atatürk University Medical Faculty Hospital and after obtaining written consent from the participating patients. The study will include pregnant women aged 20 to 45 with American Society of Anesthesiologists (ASA) II classification, full-term, nulliparous and singleton pregnancies. Using a randomisation procedure, the participants will be allocated into two equal groups: Group I and Group II.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy nulliparous women
2. American Society of Anaesthesiology Score of II
3. During active labor
4. At weeks 37-42.
5. Singlet vertex presentation
6. Cervical dilation \<5 cm at the request of labor analgesia
7. VAS score \>40

Exclusion Criteria:

1. Age \<20 or \>45,
2. Morbid obesity
3. Presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia)
4. History of drug abuse
5. Contrindication for neuraxial blocks
6. Conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries)
7. Diagnosed fetal abnormalities
8. Cases where dura gets punctured unintendedly with the epiduralneedle
9. Cases where flow of cerebrospinal fluid (CSF) is not observed after dural puncture
10. Cases where a cesarean section is performed at any stage of labor
11. Cases where labor is completed in 1 hour from the start of analgesia procedure.

Exclusion Criteria:

-
Role of Exercise for Wound Healing in the Larynx

The purpose of this study is to explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.

The objective is to use the following operationalized question: Does a voicing mode shown to correspond to high-amplitude, low impact vocal cord oscillations, "resonant voice," improve the amount and time-course of recovery from acute phonotrauma, compared to vocal rest or spontaneous speech, as measured with molecular assays (primarily) and with behavioral and clinical tests (secondarily)?

Eligibility Criteria:
Inclusion Criteria:

* males and females who have had voice training and feel they are able to produce loud voice safely;
* ages 18-49;
* generally healthy;
* normal hearing bilaterally at 20 dB to 8,000 Hz; and
* demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.

Exclusion Criteria:

* current chronic voice problems;
* current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
* heightened gag reflex;
* small nasal passage;
* deviated septum; and
* known or suspected allergy to anesthetics.
Symptomatic Treatment of Common Cold Symptoms

A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* Onset of cold symptoms within 48 hours before screening
* Objective symptoms of common cold
* Subjective symptoms of common cold

Exclusion Criteria:

* Pregnancy or lactation period
* Active peptic ulcer
* Hemorrhagic diathesis
* History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
* Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
High Intensity Interval Training in Endometrial Cancer

This interventional trial recruits women with endometrial cancer to participate in high intensity interval training (HIIT) prior to their standard of care surgery. The study will evaluate tissue and blood to determine if HIIT training has anti-cancer effects. P

Primary Objectives:

1. Determine the anti-proliferative effect of HIIT on the endometrium of women with endometrial cancer 2. Participants will undergo baseline testing, be taught how to perform personalized HIIT training prior to surgery, and repeat testing after surgery. Tissue specimens will be collected from standard of care biopsy (no extra biopsy needed) and during surgery. Blood will be collected twice during standard of care blood draws.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of endometrial cancer who are to undergo hysterectomy and staging
* Between 40-75 years old
* Body mass index of 30-50 kg/m2
* Endometrioid histology endometrial cancer
* Presumed clinically early stage disease (disease confined to uterus only)
* Have access to a Smart Phone
* Have access to email
* Agree to visit the exercise and sport science laboratory within 2 days of SOC visit for baseline testing if enrollment procedures cannot be done on the same day.

Agree to visit clinic 2 (+/-2wks) weeks after surgery for SOC follow-up and post surgery visit, or willing to return to exercise and sport science laboratory 2 (+/-2wks) weeks post-surgery

Exclusion Criteria:

* Meets American College of Sports Medicine Guidelines for physical activity (150 minutes / week)
* Currently doing HIIT
* Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
* Active diagnosis of psychosis or current uncontrolled substance abuse disorder
* Insulin-dependent diabetes
* Currently in another EC intervention
* Severe dementia or other memory loss condition
* Severe mental health disorder
* Severely impaired hearing or speech
* Inability to speak English
* Musculoskeletal or neuromuscular condition that limits physical activity Any condition, in the opinion of the investigators, which would prohibit safe participation.
Effect of NMES+ on Hamstring Lesion (3a/3b)

The goal of this clinical trial is to analyze the effect of the electrical stimulation superimposed onto movement in healthy semi-professional athletes who sustained a type 3a/3b hamstring strain injury.

The main questions it aims to answer are:

* Is NMES+ useful for the treatment of type 3a/3b hamstring strain injury?
* Does NMES+ improve the quality of the injured muscle tissue? Participants will follow a 3 week protocol, following the latest evidence available.\[describe the main tasks participants will be asked to do, treatments they'll be given and use bullets if it is more than 2 items\]. If there is a comparison group: Researchers will compare \[insert groups\] to see if \[insert effects\].


Eligibility Criteria:
Inclusion Criteria:

* recreational or semi-professional athletes
* Body Mass Index between 18,5 e 24,9
* Hamstring strain lesion type 3a/3b

Exclusion Criteria:

* previous hamstring strain lesions
* Anterior Cruciate Ligament Reconstruction using Hamstring graft
* Current hamstring strains
Opinion of Patients Under Treatment That Meets the Criteria of New Treatment Strategy According to GINA 2006

Cross-sectional, one visit study. All the data will be collected through questionnaires. Descriptives statistics will be applied to the data. 832 patients will participate to the study and 104 physicians.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with persistent asthma (GINA 2005) for at least 6 months before entering the study
* Patients who are under treatment according to the new strategies described in GINA 2006 for at least 3 months before entering the study

Exclusion Criteria:

* Patients who are not willing to sign the Informed Consent Form
* COPD Patients
Learning Through Play (LTP) Plus Interpersonal Psychotherapy (IPT)

To evaluate the effectiveness of a telephone based LTP Plus intervention for maternal depression.

Despite the high prevalence of maternal depression in Pakistan, research on psychosocial interventions is limited. We will test the effectiveness of a telephone based intervention program called Learning through Play plus Interpersonal Psychotherapy (LTP Plus) that can be used by non-specialists, including trained graduates, mothers and lay health workers with minimal training. This telephone communication will be supplemented by the provision of LTP Plus pictorial calendars to the depressed mothers.

Purpose of this RCT is to determine if telephone delivered intervention of the LTP plus programme reduces symptoms of maternal depression and improves infant development compared to Treatment as usual. A sample of 354 (177 in each group) will be required. The study will be conducted in big cities of Pakistan including Karachi, Lahore, Hyderabad, Nawabshah, Quetta and Peshawar.Participants will be screened using Patient Health Questionnaire (PHQ-9) and eligibility checklist. Those scoring 10 and above on PHQ-9 will be invited to participate in the study. Assessments will be done at baseline and after completion of intervention (3rd month and 6th month after randomization). All follow ups will be done by independent Research Assistants (RAs), blind to the treatment allocations.

Eligibility Criteria:
Inclusion Criteria:

Participants will be included in the study if they are:

18 to 44 years old mothers with children aged between 0-30 months having a diagnosis of major depressive disorder using the Structure Clinical Interview for DSM-V, Ability to complete a baseline assessment, Participating mother having telephone/mobile phone access for at least one hour per week.

Exclusion Criteria:

Participants will be excluded from the study if they have:

Any medical illness that will prevent them from participation in the clinical trial, current or past diagnosis of bipolar depression, currently using antidepressants or receiving any kind of psychotherapy, active suicidal ideation, any other severe physical or mental disorder, no access to telephone/mobile.
Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female Patients at least 18 years old
* Patient who have rare tumors of neuroendocrine origin, such as tumors of the:

  1. pancreas
  2. pituitary glands
  3. Nelson syndrome
  4. ectopic-ACTH secreting tumor
* Patients who have failed standard of care treatment or for whom no standard of care treatment exist
* Signed Informed Consent

Exclusion Criteria:

* Patients with active gallbladder disease
* Patients with any ongoing or planned anti-neoplastic or interferon therapy
* Poorly controlled diabetes mellitus
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control

Other protocol-defined inclusion/exclusion criteria may apply.
Screening for Risk Factors of Prediabetes Among Adult Patients at Sohag University Hospital

* Prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold..
* during the average 3 years of follow-up Prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;HbA1c, (5.7-6.4%) or plasma glucose level after an oral glucose tolerance test ( 140-199 mg/dl).
* Reports estimate that more than 470 million people will have prediabetes by 2030.
* According to an expert panel of the American Diabetes Association, up to 70% of individuals with prediabetes will eventually develop diabetes.
* Observational evidence suggests as association between prediabetes and complications of diabetes such early nephropathy(10%) , small fiber neuropathy(18-25 %), early retinopathy (8-12%) and risk of macrovascular disease (52%) .
* Screening for prediabetes is designed to save lives or enhance an individual's quality of life by early detection so that screening will minimize the risk of developing diabetes or its complications .

* In this case control study we aim to screen for risk factors of prediabetes among adult patients to minimize the risk of developing diabetes or its complications .
* Prediabetes screening is also required to minimize medical costs such as hospitalization, outpatient care, surgery, medications, and laboratory test costs .
* Several studies had shown efficacy of lifestyle interventions in diabetes prevention by targeting obesity with increase in physical activity and dietary changes with a relative risk reduction of 40%-70% in adults with prediabetes ,also there is increasing evidence to prove the efficacy of pharmacotherapy in prevention of diabetes in adults with prediabetes

Eligibility Criteria:
Inclusion Criteria:

* Adult patient above 18 years old .

Exclusion Criteria:

* all patients known to be diabetics .
* pregnancy .
* chronic depleting diseases,
* Those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
Kinesio Taping in Cerebral Palsy Upper Extremity Functionality

Purpose: The aim of this study is to investigate the effects of kinesio taping on upper extremity functionality in participants with Cerebral Palsy.

Methods: This study included 14 children aged 6-16 years, diagnosed with Cerebral Palsy. The children with Cerebral Palsy were divided into 2 groups, the study group and the control group. Assessments were done three times for each group (beginning - 45min later - 1 week later). Frenchay Arm Test was used to evaluate upper extremity functionality in participants with Cerebral Palsy. Kinesio taping was applied to study group to improve posture and function in shoulder area.


Eligibility Criteria:
Inclusion criteria were as follows;

* To have a cognitive level to comprehend the instructions
* Not having a cooperative problem that may prevent communication
* Continuing special education regularly Exclusion criteria were as follows;
* Those with orthopedic problems
* Any surgical procedure
* Participants with cognitive problems
* Participants who do not regularly receive physiotherapy
Improving Health Behaviors for Pediatric Cancer Survivors

The objective of this study is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers.

Advances in treatment have led to a rapidly growing population of over 388,500 survivors, with 13,500 new survivors expected annually. However, chronic or long-term side effects (e.g., secondary malignancies, metabolic syndrome, cardio-pulmonary toxicities) can reduce quality of life and lead to premature death. The investigators propose that diet and fitness are two critical factors for healthy survivorship given their broad impact on late effects like obesity, fatigue, and metabolic syndrome. Despite the promise of comprehensive lifestyle interventions for children who are overweight or obese, research with survivors is limited by small samples and inconsistent effects. Novel research supports a key role for the gastrointestinal (GI) microbiome in regulating weight and health outcomes, yet no studies have examined the "obesogenic" microbiome in the context of lifestyle interventions for survivors of childhood cancer. The objective of this RCT is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers. Families will be randomized to participate in HH4K or enhanced usual care. Dietary patterns, physical activity, cardiometabolic indices, family outcomes, and GI microbiome will be assessed and the HH4K group will demonstrate greater improved than enhanced usual care.

Eligibility Criteria:
Inclusion Criteria:

* 8-12 years of age
* previously diagnosed with any type of pediatric cancer
* within 5 years post-treatment for pediatric cancer
* fluent in English, with at least 1 fluent parent
* living within 75 miles of the medical center

Exclusion Criteria:

* significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires
* Referral to hospice or at end of life.
The Comparison of 32mm and 28mm Head Components in Alumina-alumina Total Hip Arthroplasty

It has been postulated that use of a larger femoral head could reduce the risk of dislocation after total hip arthroplasty, but only limited clinical data have been presented in third generation alumina bearings.

The purpose of this study is to evaluate the effect of femoral head size for total hip arthroplasty using third generation alumina bearings on the joint stability and clinical results.

The investigators hypothesized that larger ceramic head group has a similar rate of dislocation and clinical results in smaller ceramic head group.


Eligibility Criteria:
Inclusion Criteria:

* osteonecrosis of femoral head
* primary or secondary osteoarthritis of the hips
* femoral neck fracture

Exclusion Criteria:

* previous hemi- or total hip arthroplasty
* highly dislocated or severe ankylosed hip
* patients who are considered potentially unreliable or who may not reliably attend study visits