cyrilzakka/clinical-trials huggingface dataset:
Effects of MDRT vs CEE on Pulmonary Functions, Chest Expansion and Asthma Control in Asthma Patients

To determine the effects of manual diaphragmatic release technique (MDRT) versus chest wall expansion exercises on pulmonary function, chest wall expansion and asthma control in patients with asthma.

Patients who will meet the inclusion criteria will be recruited by convenient sampling technique and allocated to groups by simple randomization process by sealed opaque enveloped labeled as A for Group A and B for group B. At the beginning of the study, a formal educational session, lasting about 30 minutes will be given by the physiotherapist dealing with the treatment/interventions.

Group A: It will receive MDRT and generalized body stretching. Group B: It will receive Chest Expansion Exercises and generalized body stretching.

Frequency of patient's visit will be tailored with minimum of 2-3 visits per week for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* • Medically diagnosed asthma patients.

  * Aged 35-60 years.
  * Patient should be non-smoker or ex-smoker for last 6 months

Exclusion Criteria:

* • Patients having other cardiac or respiratory diseases.

  * Patient having thoracic or abdominal surgeries.
  * Pregnancy and uncontrolled hemodynamic parameters.
  * Inability of Patient to understand instruction due to mental disorder.
Emotion Regulation Skills Training for Individuals With MS and Their Support Partners

This pilot randomized controlled trial investigates a novel, group-based emotion regulation skills training intervention for reducing anxious and depressive symptomatology and improving emotion regulation and problem solving in individuals with MS and the individual's support partners. Participants will be randomized (1:1) to the intervention ("Partnered Emotion Regulation Skills Intervention and Supportive Teaching \[PERSIST\]") or to the active control (Facilitated Peer Support).


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* able to speak/read in English
* able to commit to attending at least 9 of the 12 weekly group sessions
* individuals with MS must be relapse/exacerbation-free for at least 1 month
* support partners must score at least 8 on the HADS-D or HADS-A
* individuals with MS must score a least 11 on the HADS-D or HADS-A

Exclusion Criteria:

* under 18 years old
* unable to speak/read in English
* unable to commit to attending at least 9 of the 12 weekly group sessions
* MS relapse within 1 month
Radiation Therapy for ypN0 Breast Cancer

This is a phase III randomized study comparing regional nodal irradiation vs. no irradiation for breast cancer patients presenting with node positive disease who turns into node negative after preoperative chemotherapy


Eligibility Criteria:
Inclusion Criteria:

* WHO performance status 0-1
* Invasive Breast Cancer with cT1-3 cN1-2 at time of diagnosis
* Axillary nodal involvement can be detected using, clinical examination, ultrasound, CT scan or PET scan
* Pathologic confirmation using, FNAC, core biopsy or excisional biopsy
* ER, PR, Her2 neu and Ki67 status should be available for all patients
* All patients should have received standard preoperative chemotherapy prior to surgery
* At the time of surgery, all patients should have axillary clearance with at least 6 nodes harvested from the axilla
* Patients who have undergone mastectomy or lumpectomy with negative margins with ypN0, ypN0(+i) or ypN0(+mol) are eligible for randomization

Exclusion Criteria:

* Poor performance status
* Definitive clinical or radiologic evidence of metastatic disease
* T4 tumors including inflammatory breast cancer
* N3 disease detected clinically or by imaging
* Patients with histologically positive axillary nodes after preoperative chemotherapy
* Positive surgical margin after definitive surgery
* Previous ipsilateral or contralateral breast cancer
* Previous chest wall or breast irradiation
* Second primary cancer
* Active connective tissue disease
The Effect of Cocoa Flavonoids on Blood Pressure

The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.

Flavonoids are natural substances found in fruits and vegetables, tea and red wine. The investigators know that people who eat a diet rich in these foods are less likely to have heart disease. This, in part, may be due to the blood pressure lowering effect of flavonoids. Cocoa beans are a rich natural source of flavonoids. Unfortunately when cocoa is made into chocolate most of the flavonoids are destroyed. The aim of this study is to find out the effect of cocoa flavonoids on blood pressure after 12 weeks of daily consumption of a specially prepared chocolate drink that is rich in flavonoids.

Eligibility Criteria:
Inclusion Criteria:

* Males or females of any age.
* Diagnosis of hypertension and on antihypertensive treatment.
* Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (\<150/90mmHg).

Exclusion Criteria:

* Participation in another clinical trial.
* Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.
Post-operative Pain Control of Testicular Sperm Extraction Using Liposomal Bupivacaine

The study is a drug trial comparing the post-operative pain control provided by liposomal bupivacaine (a local anesthetic) against standard bupivacaine (a different formulation of the local anesthetic) for men undergoing testicular sperm extraction.


Eligibility Criteria:
Inclusion Criteria:

* Men scheduled for surgical sperm retrieval for infertility
* Men 18 years and older who can provide informed consent
* No documented allergy to bupivacaine or celecoxib

Exclusion Criteria:

* Prior history of substance abuse
* Any narcotic use within the last 3 months
* Concomitant use of aspirin
* Any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses
* Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
Intensive Goal Training for Adolescents With Cerebral Palsy

Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities. The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.

We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP. Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks. Moreover, they will be asked to daily practice these activities at home along the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of bilateral CP;
* Age between 12 and 17 years old;
* Manual Ability Classification System (MACS) ranging from levels I to III;
* Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
* Ability to understand verbal instructions.

Exclusion Criteria:

* Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.
Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools

Determining the Prevalence of Molar Incisor Hypomineralization Among a Group of Egyptian Children in Fayoum Governorate Schools via clinical examination.

Participants from primary and preparatory schools in Fayoum governorate will be included in the study and Clinical examination will be carried out in the school laboratory or an empty class, in day light for both genders.

Teeth will be cleaned gently using gauze and wet with saliva during examination. A disposable diagnostic set (mirror, probe) will be used for each patient where mirrors will be used for proper visualization especially for maxillary teeth. Blunt explorers will be used to aid in tactile sensation if needed, as during the differentiation between rough and smooth enamel edges and/or during the inspection of the caries extent if it exists. No diagnostic radiographs will be taken.

The results of the study will be regularly monitored by the supervisors who will have full access to these results.


Eligibility Criteria:
Inclusion Criteria:

* Acceptance for participation in the study.
* Eruption of four first permanent molars.
* Eruption of four permanent maxillary and mandibular incisors.
* Both genders.

Exclusion Criteria:

* Uncooperative children.
* Children with orthodontic appliances.
* Children with systemic diseases which may affect teeth development.
* Children suffering from any other type of enamel defect as enamel hypoplasia and amelogenesis imperfecta.
A Study Of Combined C- MET Inhibitor And PAN-HER Inhibitor (PF-02341066 And PF-00299804) In Patients With Non- Small Cell Lung Cancer

Lung cancer tumors become resistant to the first generation epidermal growth factor receptor (EGFR) inhibitors erlotinib or gefitinib by changing and increasing the activity of two cell signaling pathways: the cMET pathway and the EGFR pathway. Both resistance mechanisms can occur at the same time, in the same patient and even in the same tumor. This study combines a second generation EGFR inhibitor and a cMET inhibitor to block both these pathways in order to overcome resistance and treat this disease.


Eligibility Criteria:
Inclusion Criteria:

* advanced non small cell lung cancer (dose escalation phase)
* acquired resistance to erlotinib or gefitinib (expansion phase)
* mandatory entrance biopsy (expansion phase)

Exclusion Criteria:

* interstitial lung disease
* unstable brain metastases
* leptomeningeal disease
Impact of Nicotine on Retinal Vascularization

The main hypothesis is the nicotine is associated with a modification of retinal micro-vascularization.

Patients will be recruited during their ophthalmologic consultation at the Rothschild Foundation, an OCT-A will be realized and data relating to medical history, oral contraceptive intake and nicotine consumption via cigarette or e-cigarette data will be collected.

The objective is to seek an association between retinal vascular density and inhaled nicotine intake.


Eligibility Criteria:
Inclusion criteria

* For group of smokers: Patient reporting active smoking for at least 3 months and at least 1 cigarette per day on average over a week
* For group of vapers : Patient using exclusively the electronic cigarette with a nicotine level of more than 6mg/ml for at least 3 months and at least 1 times per day on average over a week.
* For group of no-smokers no-vapersNon-smoking and no vaping, for more than 6 months

Non-inclusion criteria:

* Caffeine intake within 2 hours prior to the OCT-A exam
* ametropia greater than + 3 dioptres of hyperopia or-3 dioptres of myopia
* astigmatism greater than 2 dioptres
* Known retinal or retina vascular pathology
Effect Of Methylphenidate On Balance In Children With Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder that may have poor motor coordination and balance control. The effect of Methylphenidate treatment on balance and fall risk is still unclear. This study aimed to evaluate the effect of methylphenidate (MPH) treatment on balance, fall risk, and sensorimotor integration in children with Attention Deficit Hyperactivity Disorder (ADHD).

Children who were diagnosed with ADHD for the first time were classified in the ADHD group (n=33), children with ADHD who were treated with MPH for a minimum of 3 months were classified in the treatment group (n=32), and typically developing children were classified in the third-the control group (n=20) in this observational cross-sectional study. Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.Postural stability tests, including overall stability index (OSI), anterior-posterior stability index (APSI), and medial-lateral stability index (MLSI), were used to evaluate postural control. The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) testing protocol was used to evaluate sensory integration capabilities and balance. Fall risk was evaluated by biodex balance system.

Eligibility Criteria:
Inclusion Criteria:

* Children who were diagnosed with ADHD for the first time according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric Association, 2013)

Exclusion Criteria:

* neurological disorders
* psychiatric disorders
* musculoskeletal disorders
* cardiopulmonary diseases
* visual impairments
* developmental coordination disorders that could affect balance
Randomized Ph 2 Trial Of Paclitaxel/Carboplatin /Bevacizumab + PF-3512676 And P/C/B Alone In Advanced Nonsquamous NSCLC

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel, carboplatin and bevacizumab as first-line treatment in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer

PF-3512676 dosing was stopped 21 June 2007 when Pfizer decided to stop the administration of PF-3512676 in all trials which combined PF-3512676 with cytotoxic chemotherapy. the decision was made subsequent to DSMC recommendation to close two phase III randomized trials in non-small cell lung cancer which also combined PF-3512676 with cytotoxic chemotherapy, citing lack of efficacy concerns as the primary reason with safety issues (sepsis, thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 22 May 2008.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Stage IIIb with pleural effusion or Stage IV nonsquamous non-small cell lung cancer
* ECOG Performance Status 0-1
* Measurable disease per RECIST criteria

Exclusion Criteria:

* Squamous cell, small cell, or carcinoid lung cancer
* CNS metastasis
* Pre-existing autoimmune or antibody mediated disease
* Prior systemic treatment for NSCLC with chemo, immunotherapy, biologics, or investigation drugs
Effect of Chicken Egg Antibody (IgY) on Patients With Chronic Gastritis

H. pylori positive patient volunteers that passed the selection criteria are recruited and divided into a test and a control group. Both groups are treated with a current treatment regime (EAC: Esomeprazole 40 mg/day; Clarithromycin 1000 mg/day; Amoxicillin 2000 mg/day) but only the test group received IgY-containing food supplement as an adjunctive measure for 15 days. The subjects are examined before and 4 weeks after the treatment initiation by Urea Breath Test (UBT) and gastro-endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with gastritis or gastric ulcer who are positive to H. pylori

Exclusion Criteria:

* People allergic to egg proteins
(3D) Ultrasound Imaging Liver and Kidney

This study is to assess the addition of 3D ultrasound guidance during standard care ablation or biopsies of liver or kidney tumours. 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-demensional volume , allowing area in question to be viewed in many different planes. 3D ultrasound is a safe, fast, non-invasive imaging procedure. Ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed or properly targeted during biopsy.

Images will be acquired by a physician on patients who are undergoing a liver or kidney ablation or biopsy procedure who are well enough to provide consent. Patients will be imaged during the ablation procedure according to the standard of care, and subsequent analysis will commence following the acquisition. The devices being used are all property of the LHSC health network that have been licensed for clinical use through Health Canada. In addition, 3D ultrasound only differs from conventional 2D ultrasound in that the ultrasound transducer is mounted on a special assembly that moves the transducer in precise, stepped movements while a succession of 2D images are collected by the computer. Special software written specifically for 3D ultrasound precisely aligns these 2D images into a 3-dimensional volume, allowing the area in question to be viewed in different planes. The clinical 2D an d3D ultrasound images will be checked against the pre- and post- procedure CT images to make sure the tumours were completely removed.

Eligibility Criteria:
Inclusion Criteria:

* • Patients who are scheduled for standard care liver or kidney ablation or biopsy

Exclusion Criteria:

* None
Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus

This study will be a randomized controlled trial in which there will be comparison of the effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal pilonidal sinus


Eligibility Criteria:
Inclusion Criteria:

* Patients with pilonidal sinus of any sex and aged 20 years or above
* Non infected pilonidal sinus

Exclusion Criteria:

* Infected pilonidal sinus
* Uncontrolled diabetes
* Patient on immunosuppressive therapy
Identification of EMT Indicators in Healthy and Periodontally Diseased Gingival Samples

The current study focuses on the localization and quantitative assessment of growth factors and cytokines related to the EMT process found in the human gingival tissue samples taken from periodontally diseased individuals compared to other samples taken from healthy individuals. Through this investigation the correlation between the severity of the disease and the amount of these factors will be studied aiming to alleviation of the high prevalence of periodontal diseases among the Egyptian population.

In a case control human study The existence and the amount of the indicators and cytokines for EMT in the gingival tissue samples taken from the periodontitis patients will be investigated and compared to those in healthy individuals using histopathology and real time PCR to reveal the role of these factors in periodontal disease incidence in humans.

Total of 36 participants will be recruited in this study The participants will be divided according to their periodontal status into four groups (healthy, mild, moderate and severe periodontitis) 9 patients in each group.

The periodontal screening of patients will be done using mouth mirror and graduated Williams's periodontal probe for the following:

* Gingival status will be assessed by using gingival index
* Periodontal pocket depth.
* Clinical attachment loss.
* Radiographic examination using panoramic technique. Screening criteria for chronic periodontitis was the presence of at least 5 sites with 4 mm horizontal alveolar bone loss on radiographs.

Gingival tissue samples will be harvested during periodontal surgery and extraction of the periodontally hopeless tooth for the periodontitis patients and during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls.

The dissected gingival samples will be washed in saline solution and fixed in 4% buffered formalin for 48 hours, dehydrated in ascending grades of ethyl alcohol, cleared in xylene and embedded in paraffin and will be subjected to the following:.

1. Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis.
2. Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin .

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for healthy group:

  * Absence of any clinical sign of gingival inflammation
  * Probing depth ≤3 mm
  * No clinical attachment loss.

Inclusion criteria for periodontitis group:

* Generalized presence of clinical signs of gingival inflammation
* Generalized probing depth ≥4 mm
* Generalized clinical attachment loss of ≥2 mm.

Exclusion Criteria:

* • Patients with any systemic disease,

  * Smokers
  * Pregnant or lactating women,
  * Cervical/proximal/subgingival caries or restorations,
  * Periodontal or antimicrobial therapy within 3 months before sampling.
Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention.

Family psychoeducation (FPE) is an evidence-based practice used in high-income countries to help individuals with psychotic disorders and their relatives to cope more effectively with the illness. FPE has never been tested in a low-resource country nor have the mechanisms of action for this psychosocial intervention been fully identified in any context. The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (called KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention. Formative research has already been conducted to culturally tailor the model for the Tanzanian context. This pilot study is a small randomized controlled trial (RCT) with 72 patient/relative dyads that will test the KUPAA intervention to a) assess the feasibility and acceptability of the adapted family psychoeducation intervention for 12 weeks, and b) explore its impact on patient relapse, quality of life and disability.

Primary study objectives

1. To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life and disability

   Secondary study objectives
2. To elucidate the mechanisms of action for KUPAA (e.g. hopefulness, self-efficacy) and refine the mediation and study outcome measures for a future R01/fully powered clinical trial

Eligibility Criteria:
Patient Inclusion Criteria:

* Attending outpatient psychiatric services at Muhimbili National Hospital (MNH) or Mbeya Zonal Referral Hospital (MZRH).
* ICD-10 Diagnosis of a non-organic psychotic disorder:
* F20 Schizophrenia
* F21 Schizotypal disorder
* F22 Delusional disorders
* F25 Schizoaffective disorders
* Age 18-50 at the time of informed consent
* Hospitalization or relapse (confirmed by attending psychiatrist or medical officer) within the past 12 months.

Patient Exclusion Criteria:

* F23 Brief psychotic disorder
* F28 Other psychotic disorder not due to a substance or known physiological condition
* F29 Unspecified psychosis not due to a substance or known physiological condition
* Epileptic psychoses
* Bipolar disorder and mania
* Co-morbid developmental disorder, dementia, or other severe cognitive deficit that renders the individual unable to provided informed consent.

Caregiver Inclusion Criteria:

* Age 18 or older at time of consenting process
* Patient agrees that this person can be their paired partner for KUPAA if the pair is randomized to the intervention group