cyrilzakka/clinical-trials huggingface dataset:
Biomechanical Aligment of Lower Limb as a Predictor for Stress Urinary Incontinence in Postmenopausal Women

This study will be conducted to assess biomechanical alignment of lower limb as a predictor for the stress urinary incontinence in the postmenopausal women. 300 postmenopausual women will be selected suffering from stress unrinary incontinence . Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2.

in this study 300 postmenopausual women will be selected suffering from stress unrinary incontinence. Their age ranges from 60 to 70 years old. Their BMI is not exceeding 30 kg/m2. different methods of assessment will be used as : Data recording sheet, Weight-Height scale, Goniometer ,x ray radiography ,Transabdominal ultrasound and Perineal ultrasound. Data recording sheet: It will be used to record data of each woman before starting this study. Weight-Height scale: It will be used to measure weight and height of each woman before starting this study. Goniometer: it will be used to document the initial and the subsequent range of motion for ankle joint for each woman. Transabdominal ultrasound: it will be used for measurement of Post-void residual volume PVR for each woman which is the volume of urine left in the bladder after micturition . Perineal ultrasound: it will be used to assess the posterior urethrovesical angle for each woman . X-ray radiography: lateral pelvic radiographs will be taken for each woman in order to objectify the individual pelvic tilt. Inclusion criteria include : Subjects will be postmenopausal women complaining from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2. Exclusion criteria: previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index \>30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)

Eligibility Criteria:
Inclusion Criteria:

Subjects will be 300 postmenopausal women suffering from stress urinary incontinence Participants age will range from 60-70 years.Their BMI will not exceed 30 kg/m2

Exclusion Criteria:

* previous history of cancer and radiotherapy, any disease that could interfere with the participation, lower urinary tract infections( Manshadi F. etal ) musculoskeletal problems; previous major abdominal or pelvic surgery; severe diseases; diabetes mellitus, a body mass index \>30 kg/m2; intraureterine device implantation, pelvic organ prolapse and menopause (Cerruto M etal.)
Safety and Pharmacokinetic Study of C13-URA in Healthy Volunteers

The purpose of this study is to evaluate the safety and establish the pharmacokinetic (PK) profile of C13-URA in healthy volunteers

The C13-URA Breath Test Kit is intended to be used as a diagnostic tool to identify rapid and/or delayed gastric emptying in patients who have upper GI symptoms such as stomach pain, fullness, early satiety, vomiting, etc., and who have suspected gastric emptying abnormalities such as gastroparesis or dumping syndrome.

This study will be a double-blind, placebo-controlled, 3-period safety and PK study of 13C-uracil administered as a single oral dose of 50 mg at step 1 (Period 1), 100 mg at step 2 (Period 2), and 200 mg at step 3 (Period 3) in the form of a semi-solid meal to subjects following at least a 10-hour fast from food and 2-hour fast from water. Dosing will be followed by a 6-hour fast from food and a 4-hour fast from water. There will be a washout of at least 7 days between doses.

The objectives of this study are as follows;

1)to evaluate the safety of 13C-uracil in a semi-solid meal in healthy volunteers, 2)to establish the pharmacokinetic profile of 13C-uracil in a semi-solid meal in healthy volunteers, 3)to assess the correlation between plasma concentration of 13C-uracil and urinary excretion of 13C-uracil, 4)to evaluate the reproducibility (intra/inter-individual variance) of the breath test, 5)to determine the dose for 13C-uracil that facilitates adequate Δ13C in breath expired by healthy volunteers

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \[range is 18.5 to 29.9 kg/m2\]
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, and vital signs

Exclusion Criteria:

* Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (except that appendectomy, hernia repair, and/or cholecystectomy will be allowed)
* History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically significant
Effects of Myofascial Release With and Without EMMETT Technique in Iliotibial Band Syndrome

The iliotibial (IT) tract or band is a lateral thickening of the fascia lata that is composed of the distal fusion of the muscular fascia of the gluteus maximus and tensor fascia lata muscles. The iliotibial tract travels along the lateral side of the thigh and across the knee joint, inserting on the lateral epicondyle of the tibia. A tight IT band has been diagnosed in several problems related to the knee including patellofemoral syndrome and iliotibial band syndrome. Several authors have suggested that tightness in the IT band may contribute to patellofemoral syndrome and knee pain by pulling the patella laterally thereby causing abnormal tracking of the patella in the trochlear groove. Stretching of the iliotibial band is frequently recommended in treatment programs for patients with LBP. Because the iliotibial band attaches to the ilium, tightness of this muscle is thought to cause anterior innominate rotation and lateral pelvic tilt. The Ober test is performed to assess tightness in the iliotibial band.

The term myofascial release encompasses various techniques used to release fascial restrictions. Many forms of bodywork that includes a soft tissue technique exist with Bowen therapy, Emmett technique, deep tissue massage, neuromuscular techniques (NMT), Muscle Energy Techniques (MET) and foam rolling.

This study focusses on effects of myofascial release with Emmett technique. This study will be conducted in a clinical set up (Saba's physical therapy, rehabilitation and sports injury clinic in Gulberg 3) and will take 6 months. Study will be conducted on 22 subjects involving 11 subjects in each group. Group A will be given myofascial release only and group B will be given myofascial release with Emmett technique. Total duration of study will be three weeks and assessment will be done before treatment and after every week. Numeric pain rating scale, goniometer and vertical jump test are used for assessing pain, flexibility and power respectively.


Eligibility Criteria:
Inclusion Criteria:

* Positive Ober's Test
* Both males and females
* Age 25 to 45 years

Exclusion Criteria:

* TFL (Tensor Fascia Lata) tightness
* Any pathological and traumatic conditions, Fractures and Dislocation,
* Already received few sessions of Manual Therapy treatment
* Taking corticosteroids, analgesic or anti-inflammatory drugs.
* Treatment of lower limb myofascial pain or trigger points at the time of the study • Current or previous symptoms of pathology reported in the lower limbs or pelvis
A Study to Test the Potential of Brillouin Microscopy for Biomechanical Properties Measurements in Human Cornea

The purpose of this research study is to find out if the new Brillouin Ocular Scanner can measure the variation (difference) of the corneal elastic changes involved in the onset of corneal ectasia, induced by LASIK surgery and cornea collagen crosslinking (CXL) treatment. Ectasia refers to the thinning and bulging of the cornea and results in severe vision degradation (loss), which may occur because of a progressive disease (keratoconus) or because of LASIK surgery. It is believed that the structural weakening of the cornea plays a major role in developing ectasia. CXL is a treatment that is able to halt the progression of ectasia.

The Brillouin Ocular Scanner is a technique based on the principles used in the laser speed measuring of a car (radar gun). When laser light illuminates a moving sample, a portion of the light slightly changes color. In our body, e.g in eye and corneal tissue, very weak sound waves are naturally present and they can induce a similar color shift. Measuring this color shift with a sensitive light color meter (spectrometer), we will measure the sound speed in the tissue.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with healthy cornea
* Patients with mild, moderate, or advanced keratoconus
* Subjects diagnosed with PMD
* Patients before and after LASK surgery
* Patients with keratoconus before and after collagen crosslinking treatment

Exclusion Criteria:

* Normal volunteer group: presbyopia and/or cataract
* Keratoconus subjects group: corneas with scars developed, received any ocular surgery, such as laser vision correction surgeries or CXL treatment
* Subjects diagnosed with PMD: excludes corneas received any ocular surgery, such as laser vision correction or CXL treatment
* Patients before and after LASK surgery Corneas received priori ocular surgeries, taking any ocular medications except season allergy medicine such as artificial tears
LLETZ Under General Versus Local Anesthesia

The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* colposcopy Prior to conization
* informed consent
* histologically proven high grade cervical dysplasia
* Transformation zone typ 1 or 2

Exclusion Criteria:

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
* oncological disease
* inpatient treatment
* women who are not fasting
* risk of aspiration
* columnar-squamous epithelium border not fully visible
Gemcitabine and Platinol Followed by Pemetrexed and Gemcitabine in Patients With Advanced or Metastatic Bladder Cancer

The purposes of this study are: To determine the maximum tolerated dose of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine in patients with advanced or metastatic transitional cell carcinoma of the urothelium; To determine the safety of Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine and any side effects that might be associated with the combination of these drugs; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can help patients with advanced bladder cancer live longer; To determine whether Gemcitabine and Platinol followed by Pemetrexed and Gemcitabine can make your tumor smaller or disappear, and for how long.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven metastatic bladder cancer
* No prior chemotherapy for metastatic disease except before or after surgery, which was completed 6 months before enrollment
* Prior radiation allowed, if it is not the only site of measurable disease and if completed 3 weeks before enrollment
* 18 years of age and older

Exclusion Criteria:

* Pure adeno- or squamous urothelial cancer
* Brain metastases that causes symptoms
* Have not received treatment within the last 30 days with a drug that has not received regulatory approval for any indication
* Inability to take dexamethasone, folic acid or vitamin B12, according to the protocol
* Clinically relevant fluid collection in the lungs or abdomen that cannot be controlled
Endoscopic Full Thickness Biopsy, Gastric Wall.

The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.

Our group has studied a new endoscopic method using a submucosal endoscopy with mucosal flap (SEMF) technique to acquire full thickness gastric tissues successfully and safely in preclinical studies.

The proposed study will assess the efficacy and safety of the innovative endoscopic technique for the acquisition of full thickness gastric muscle wall biopsies. Having access to full thickness biopsies will allow an increased understanding of the pathophysiology of gastrointestinal diseases such as functional gastrointestinal disorders, gastroparesis, pseudoobstruction and other motility disorders. This information is essential to development of more targeted and effective therapy than currently available. Despite the high prevalence of functional gastrointestinal disorders and its significant impact on social and health care costs, the underlying cause is not well understood and there is no effective specific treatment to successfully alleviate patient symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic refractory idiopathic gastroparesis:

   1. The refractory nature of symptoms (e.g. based on nutritional failure, consideration for enteral or parenteral nutrition) will be determined by the physician/gastroenterologist who is the primary care provider for the patient's gastroparesis.
   2. Patients will have documentation within the last 2 years of delayed gastric emptying with \>30% retained gastric contents at 4 hours based on 296 kcal solid-liquid, fat-containing standard meal gastric emptying test.
   3. The patient's physician will determine if this procedure may potentially provide prognostic and therapeutic options.
2. Age \> 18 and \< 70 years old
3. Hemoglobin (Hb) \> 10g, platelets \>150,000 and prothrombin time- international normalized ratio (INR) \<1.5
4. Ability to give informed consent

Exclusion Criteria:

1. Prior oropharyngeal, esophageal, gastric or small bowel surgery
2. Esophageal stricture
3. Prior abdominal radiation therapy
4. Prior feeding tube placement
5. Coagulopathy
6. Use of Coumadin or anti-platelet drugs e.g. Plavix, steroids or immunosuppressive drugs
7. Pregnancy -
A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer)

This study will evaluate the efficacy, safety, and pharmacokinetics of immunotherapy-based treatment combinations in participants with metastatic non-small cell lung cancer (NSCLC).

Two cohorts will be enrolled in parallel in this study: Cohort 1 will consist of participants with tumor PD-L1 expression who have received no prior systemic therapy for metastatic NSCLC, and Cohort 2 will consist of participants who experienced disease progression during or following treatment with a platinum-containing regimen and a PD-L1/PD-1 checkpoint inhibitor, given in combination as one line of therapy or as two separate lines of therapy, regardless of PD-L1 expression. In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). Participants who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment regimen (Stage 2).


Eligibility Criteria:
General Inclusion Criteria

* Eastern Cooperative Oncology Group (ECOG) performance Status of 0 or 1
* Life expectancy greater than or equal to 3 months
* Histologically or cytologically confirmed metastatic, non-squamous or squamous Non-Small Cell Lung Cancer (NSCLC)
* Measurable disease (at least one target lesion)
* Adequate hematologic and end-organ function
* Tumor accessible for biopsy
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs as outlined for each specific treatment arm
* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm

Inclusion Criteria for Cohort 1

* No prior systemic therapy for metastatic NSCLC
* High tumor PD-L1 expression, defined as Tumor Proportion Score (TPS) or TCs \>= 50% or TC3

Inclusion Criteria for Cohort 2

- Disease progression during or following treatment for metastatic or locally advanced, inoperable NSCLC

Exclusion Criteria

* Prior allogeneic stem cell or solid organ transplantation
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
* History of leptomeningeal disease
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
* History of malignancy other than NSCLC within 2 years prior to screening
* Active tuberculosis
* Severe infection within 4 weeks prior to initiation of study treatment
Culturally Adapted i-CBT for Farsi/Dari Speaking Migrants

The aim of this randomized controlled trial (RCT) is to investigate the effectiveness of a culturally adapted internet-based cognitive behavioral therapy (i-CBT) intervention in reducing symptoms of common mental health issues among Farsi/Dari-speaking youth migrants and refugees. Investigator hypothesizes that there will be a significant decrease in psychological symptoms after participants receive the intervention compared to a control group.

Participants who are included in the study will be allocated to the experimental group and the control group (waiting list). Participants will be invited to participate tailored i-CBT intervention over 10-weeks. Intervention covers common psychological issues. Participants will have access to support through a chatting function, during the interventional period. Intervention effects will be measured prior-treatment, post-treatment, and 6 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 15 and 29.
* A score above the cut-off 1.75 on HSCL-25
* Has a refugee or migrant background
* Has a good and stable internet connection
* Has access to a computer, tablet or smartphone
* Is fluent in reading and writing Arabic
* Has the ability to dedicate time to take part in the intervention for 6-10 weeks.

Exclusion Criteria:

* Is suffering from a severe mental illness, such as psychosis or severe depression.
* Is suffering from substance abuse
* Is undergoing a psychological treatment
* Has a high risk of suicide
Vitamin D During Pregnancy

Vitamin D insufficiency is common globally. Pregnant women, who need an increased supply of this vitamin for the proper development of the fetus, are a significant risk group. The purpose of this study is to examine which factors - education, knowledge from non-professional sources, recommendations from medical staff - influence the use of vitamin D among pregnant women in light of the lack of a clear health policy, and to help formulating guidelines for a new health policy with specific recommendations for vitamin D dosage in pregnancy.


Eligibility Criteria:
Inclusion Criteria for the pregnant of newly post-partum women:

* women between 18-50
* pregnant or just given birth and still hospitalized
* understand and can read Hebrew

Exclusion Criteria:

* those who do not understand or read Hebrew
Computer Guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint

Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.

Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients diagnosed with internal derangement according to Wilkins stage I and II.
* Patients who would not respond to conservative treatment as a first line of treatment.

Exclusion Criteria:

* Patients with Wilkins stage III, IV, V.
* History of mandibular fracture.
* Lactating, pregnant or planning pregnancy women.
* Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus

This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.


Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent form obtained from the subject, in accordance.
* The subject is aged ≥18 years at signature of the informed consent form.
* Hospitalization status: outpatient.
* The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
* The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
* The subject's HbA1c is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria:

* The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
* The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
* The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).