cyrilzakka/clinical-trials huggingface dataset:
Treatment of Cervical Syndrome With Physium Therapy

This study aim to investigate the effects of physium therapy for improving pressure pain thresholds (PPTs), range of motion,Neck Disability Index, the multidimensional health related quality of life (SF-12) and the multidimensional health related quality of life and pain in patients with mechanical neck pain (NP).

Fifty-four participants with NP will randomly allocated to either an physium therapy (five sessions) or a physical therapy (PT) groups (ten sessions) during two weeks. Multimodal PT program included: ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage. Visual Analogue Scale (VAS), Neck Disability Index ( NDI), range of motion and (CROM), Questionnaire SF-12 and PPTs in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. T-tests and a repeated-measures multivariate analysis of variance (RM-MANOVA) were used for VAS, CROM and PPTs, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes,
* Aged between 20 and 60 years, in an
* Active state of pain and diagnosed with a month of evolution.

Exclusion Criteria:

- Patients who are pregnant, have pacemaker and those Surgically operated cervical spine - - Patients who have been treated with myofascial therapy a month earlier.
In-Hospital Portable Sleep Monitoring for the Evaluation of Obstructive Sleep Apnea (OSA)

Hypothesis: Portable sleep testing of hospitalized medical inpatients suspected of having OSA is accurate in determining the need for positive airway pressure (PAP) therapy when compared to outpatient laboratory-based polysomnography.

* Hospitalized medical inpatients referred for suspected OSA will be tested with a portable sleep apnea testing device during hospitalization.
* These patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge.
* Results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

- Hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea

Exclusion Criteria:

* Patients admitted to surgical or obstetrics/gynecology services
* Patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea)
* Patients with certain social histories (prisoners)
* Patients unable to use CPAP (facial deformity and traumatic facial injuries).
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)

Objective of the study is to find the optimal dose of the once daily oral soluble guanylate cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard therapy for heart failure with reduced ejection fraction (HFrEF).


Eligibility Criteria:
Inclusion Criteria:

* Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous diuretic treatment for HF without hospitalization) with initiation of study treatment after clinical stabilization
* Left ventricular ejection fraction (LVEF) \<45% by echocardiography at randomization

Exclusion Criteria:

* Intravenous inotropes at any time after hospitalization
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7446603 Administered Alone or in Combination With Aflibercept or Faricimab in Participants With Diabetic Macular Edema

This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of diabetes mellitus (DM) (Type 1 or Type 2) with glycated hemoglobin (HbA1c) \< 12%
* Macular thickening secondary to DME involving the center of the fovea \> 325 microns
* Decreased VA attributable primarily to DME between 25 and 73 ETDRS letters

Exclusion Criteria:

* Currently untreated DM or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1
* Uncontrolled blood pressure (BP)
* Pregnancy or breastfeeding, or intention to become pregnant during the study
* For Parts 1-4: IVT anti-VEGF treatment within 90 days prior to Day 1; For Part 5: IVT anti-VEGF treatment within 120 days prior to Day 1 or IVT anti-VEGF treatment prior to Day 1 for treatment naïve participants
* Treatment with SUSVIMOTM (ranibizumab injection) prior to Day 1
* Any IVT or periocular (sub-tenons) corticosteroid treatment within 6 months prior to Day 1
* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision
* Proliferative diabetic retinopathy (PDR) in the study eye
* Active or history of uveitis, vitritis (grade trace or above), and/or scleritis in either eye Other protocol-specified inclusion/exclusion criteria may apply
Study of REGN2810 (Anti-PD-1) in Patients With Advanced Malignancies

This is a phase 1, open-label, multicenter, ascending-dose escalation study of cemiplimab, alone and in combination with other anti-cancer therapies in patients with advanced malignancies.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of malignancy with demonstrated progression of a solid tumor (non-lymphoma) with no alternative standard-of-care therapeutic option (certain exceptions may apply).
2. At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment (certain exceptions may apply)
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that required only hormone replacement or psoriasis that does not require systemic treatment.
2. Prior treatment with an agent that blocks the programmed death-1/ programmed death-ligand 1 (PD-1/PD-L1 pathway) (certain exceptions may apply)
3. Prior treatment with other immune modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab. Examples of immune modulating agents include blockers of CTLA-4, 4-1BB (CD137), OX-40, therapeutic vaccines, or cytokine treatments.
4. Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided they are stable (i.e., without evidence of progression by imaging for at least 6 weeks prior to the first dose of study treatment, and any neurologic symptoms have returned to baseline), and there is no evidence of new or enlarging brain metastases, and the patient does not require any systemic corticosteroids for management of brain metastases within 4 weeks prior to the first dose of cemiplimab (certain exceptions may apply).
5. Immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab

The information provided above is not intended to contain all considerations relevant to potential participation in a clinical trial, therefore not all inclusion/ exclusion criteria are listed.
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese adults with schizophrenia or bipolar disorder treated with antipsychotic medications.

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication.

Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of schizophrenia or bipolar disorder
* Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
* Must be on a stable dose of medication for 1 month prior to Screening
* Are able to successfully complete placebo tablet swallow test
* Have a BMI ≥30 kg/m\^2.

Exclusion Criteria:

* Have a history of a medical condition affecting body weight (eg, poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome)
* Have poorly controlled diabetes mellitus
* Have poorly controlled hypertension
* Have a history of symptomatic hypotension
* Have a history of orthostatic hypotension.
Study to Evaluate the Long Term Safety and Efficacy of DWP16001 Compared to Placebo in the Treatment of T2DM.

The purpose of this study is evaluate the long term safety and efficacy of DWP16001 compared to placebo in the treatment of type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Participated in the prior phase 3 study (Protocol No: DW_DWP16001301) for meeting the inclusion criteria and completed the study
2. Voluntarily decided to participate in the extension study and provided a written consent on the consent form

Exclusion Criteria:

1. Those who dropped out of the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
2. Pregnant or lactating women or those who do not consent to the use of appropriate contraceptive methods during clinical trials Appropriate method of birth control for you or your partner: You must agree to one of the following

   * Either surgical sterilization (vasectomy, etc.) or insertion of an intrauterine device (copper loop, intrauterine hormone-containing system), or
   * A physical barrier method combined with either systemic hormonal contraceptives or spermicide, or
   * Use of male condom combined with either cervical cap or diaphragm
3. In case the investigator judges that participation in this extended clinical trial is inappropriate in consideration of the 24-week observation progress in the previously conducted phase 3 clinical trial (Protocol No: DW_DWP16001301)
Electronic Consent of Numerous Subjects Employing Novel Techniques Trial

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.

The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form. Through this two-arm randomized controlled trial (RCT) 120 participants will be asked to read through either a ResearchKit multi-tiered consent form administered on an iPod Touch device or a standard long-form consent form administered via paper and give their informed consent for a sham research study on health tracking apps. The participants will then be asked to answer a short series of questions (5 minutes) about the consent process in order to measure their subjective and objective comprehension. The main risk from this study is loss of confidentiality of responses, however this risk should be minimal given that protected health information (PHI) will only be collected on the consent document and all information will be stored on Duke Box in a private folder only accessible by the study team.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Able to read and understand study materials which are presented in English
* Owns or has access to a smartphone or other smart device such as a tablet or iPod

Exclusion Criteria:

* Any physical limitations which prevent the participant from using mobile and/or touch screen technologies
* Employed in a research position, clinical care position, or position which has regular exposure to clinical research
Community Mobilization for Improved Clean Cookstove Uptake, Household Air Pollution Reduction, and Hypertension Prevention

Using a focused implementation research framework, the EPIS (Exploration, Preparation, Implementation and Sustainment) model in a type-2 hybrid design, the study will be conducted in 3 phases: 1) A pre-implementation phase that will use the Exploration and Preparation domains of EPIS to: a) explore barriers and facilitators of Clean Fuel- Clean- Stove (CF-CS) use, and b) develop a culturally-tailored CM strategy for CF-CS use; 2) An Implementation phase that will use the Implementation domain of EPIS to compare in a cluster RCT of 32 peri-urban communities (640 households), the effect of CM vs. a self-directed condition (i.e. receipt of information on CF-CS use without CM) on adoption of CF-CS use; and systolic BP reduction; 3) A post-implementation phase that will use the Sustainment domain of EPIS to evaluate the effect of CM strategy vs. self-directed condition on sustainability of the CF-CS use in 640 households across the randomly assigned 32 peri-urban communities in Nigeria. The Lagos State University College of Medicine (LASUCOM) working with the MOH will oversee research coordination in Nigeria.

This study will use CM to engage in the community dialogues, organize outreach facilitation, and advocacy for the adoption of bioethanol-based and liquified petroleum gas (LPG) CF-CS across participating households. The choice of CM strategy is deliberate because, unlike western culture, African cultures are largely based on communal hierarchy.

Eligibility Criteria:
Inclusion Criteria:

* Primary adult must be a female cook;
* Must not have a paid housemaid;
* Family size must be a minimum of 2 and no more than 7 members;
* Family must use Kerosene, charcoal, LPG, or firewood as primary cooking fuel;
* The person spoken to at enrollment must be the home key decision maker;
* Must have no plans for relocation in the next year.

Exclusion Criteria:

• Does not meet the inclusion criteria
Nutrition, Physical Activity, and Cognition in Breast Cancer Survivors

The purpose of this study is to examine the relationship between nutrition, physical activity and brain function in breast cancer survivors.

The current study will examine the potential relationships between physical activity, dietary intake, body composition and cognition in breast cancer cancer survivors and age-matched women without a previous cancer diagnosis. Additionally, we will measure blood inflammatory markers to explore the relationship between lifestyle factors and inflammation.

The study involves two, 1hr appointments at Texas State University. The first visit will include cognitive testing and body composition assessment. Participants will be given an activity monitor to wear for one week and a packet of questionnaires to complete at home. At the second visit, a fasted blood sample will be collected, and participants will complete a food frequency questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer survivors must have completed primary treatment (chemotherapy, radiation therapy or both) within past 60 months
* age-matched controls must have no previous cancer diagnosis
* Female
* no history of stroke, heart attack or transient ischemic attack
* not currently pregnant; can speak, read, and write English
* can attend all testing sessions
* not blind or legally blind; nonsmoker
* no current use of computer-based brain training games (e.g. Lumosity ®, BrainHQ ®).

Exclusion Criteria:

* male
* \< 30 or \> 70 years of age
* breast cancer survivor \> 60 months from last treatment or currently undergoing primary treatment
* breast cancer survivor never treated with chemotherapy and/or radiation
* previous cancer diagnosis other than breast cancer
Trial of Hypofractionated Intensity Modulated Radiation Therapy With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor for Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Trial of Hypofractionated Intensity Modulated Radiation Therapy(IMRT) With Temozolomide and Granulocyte-macrophage Colony-stimulating Factor(GM-CSF) for Patients With Newly Diagnosed Glioblastoma Multiforme.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed and pathologically confirmed glioblastoma multiforme without an enhanced lesion beside the cerebrospinal fluid space on baseline magnetic resonance imaging
* Karnofsky performance status more than 60
* Normal liver, kidney, and bone marrow function.

Exclusion Criteria:

* Previous allergies to granulocyte macrophage colony stimulating factor
* Receiving radiotherapy
* Receiving other investigational agents
* Had uncontrolled intercurrent illnesses.
Nasal Findings in Reactive Airway Diseases

Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.Patients and methods:The study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital

Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. The worldwide increasing incidence of asthma continues to make it a global health problem . It is one of the major causes of hospitalization among children younger than 15 years of age . It carries a significant burden to children, their families, the healthcare system and the overall community. When combined with shortness of breath, chest tightness and/or cough, it is a bronchial asthma .

Pediatric wheeze be triggered by upper respiratory tract infections . The adenoids are a prominent contributor to chronic rhinitis in the pediatric population. Clinical control of chronic rhinosinusitis may be important to optimize the control of difficult-to-treat asthma. However, the relationship between chronic rhinosinusitis and asthma in children remains largely descriptive .

Eligibility Criteria:
Inclusion Criteria:

* All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital

Exclusion Criteria:

* Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)
AVACEN Treatment Method and Postprandial Blood Glucose

A double-blind crossover randomized controlled trial to investigate the effects of the AVACEN device on postprandial blood glucose. The AVACEN device creates negative pressure around the hand while heating the palm. Two sham devices, one providing heat but no vacuum and one providing neither heat nor vacuum were also used. Each subject will use each of these three devices during the first hour of a 2-hour oral glucose tolerance test on separate visits. Subjects arrived in the morning following an overnight fast. Fasting blood glucose, blood pressure, tympanic temperature, and subjective thermal ratings were measured before and throughout the 2-hour oral glucose tolerance test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Diagnosis of diabetes, diabetes medication, hypertension medication
Indirect Pulp Treatment in Primary Teeth

Conservative approaches such as indirect pulp capping techniques became popular over the last years for the management of deep carious lesions. In particular, indirect pulp-treatment (IPT) techniques have gained remarkable attention in pediatric dentistry, mainly because children require a fast and accurate treatment, besides it enables the affected primary tooth to remain in the mouth until exfoliation without causing any pain or infection.

Indirect pulp treatment is recommended for teeth with deep caries approximating the pulp with no signs and symptoms of pulp deterioration. In this treatment, the deepest layer of the remaining carious dentine (affected dentin) is covered with biocompatible material followed by an airtight restoration to achieve a good seal against microleakage, without the need to reencounter for the removal of remaining caries.

Calcium hydroxide has served as a gold standard for IPT over the years. However, the introduction of newer bioactive materials such as mineral trioxide aggregate (MTA) and Biodentine helped surpass the demerits of calcium hydroxide such as internal resorption, nonadherence to dentin, degradation over time, tunnel defects, and poor sealing ability.

Eligibility Criteria:
Inclusion Criteria:

* • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.

  * Extension of carious lesion such that complete caries removal would risk pulp exposure.
  * History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.
  * Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.

Exclusion Criteria:

* • History of spontaneous sharp, penetrating pain, or tenderness on percussion

  * Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.
  * Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
  * Pulp exposure during caries removal.
  * Parental refusal for participation.