cyrilzakka/clinical-trials huggingface dataset:
SH T00186 in the Treatment of Primary Dysmenorrhea

The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).

The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.

Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days 1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets.

Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient.

During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.

Additional examinations can be performed any time, if this becomes necessary for medical reasons.

Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.


Eligibility Criteria:
Inclusion Criteria:

* Otherwise healthy female patients with moderate to severe primary dysmenorrhea
* Prospective self-rated sum pain score of \>/= 8 during the 2 baseline cycles
* Age between 18 and 40 years (inclusive) with smoking habits as follows:

  * between 18 and 30 years of age. daily cigarette consumption not above 10
  * above 30 years of age, no smoking

Exclusion Criteria:

* Current signs of history of any forms of secondary dysmenorrhea
* Any concomitant disease of condition that requires any intake of analgesic medication
* Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
* Clinically significant depression
The Effect of Changing Angle of Bed on Pain Severity and Vascular Complications Among Cardiac Catheterization Patients

Care of CVD patients in Egypt is very complex and sensitive because of the high incidence and high mortality rate. In 2019, approximately 18.6 million deaths were attributed to CVD globally. As a consequence, cardiac catheterization remains the criterion standard for evaluation of CAD.

This study will be conducted in three phases; preparation, implementation, and evaluation.

1. Preparation phase

   * Ethical approval will be obtained from the Research Ethics Committee (REC) of the Faculty of Nursing - Mansoura University.
   * Content validity of the developed tool will be reviewed by a jury of five experts in the study field and the suggestions of the jury members will be considered.
   * The reliability of this tool will be assessed also by using Cronbach's Alpha Test.
2. Implementation phase

   * An initial assessment will be carried out for all patients to confirm that they are free from the exclusion criteria.
   * Patients will be assigned into two groups: intervention group and control group, 41 patients for each group.
   * Before the cardiac catheterization procedure: patients' demographic characteristics and health relevant data will be collected on the first day of admission using part I and part II of tool I.
   * In both groups after cardiac catheterization procedure: the sheath will be removed immediately by the nurse.
   * In the control group: positioning the patients in supine for 6 hours and the affected leg was straight and immobilized.
   * In the intervention group: the researcher will change angle of bed from 15° to 45°.
   * The severity of pain will be assessed by using part III of tool I for five times starting immediately after sheath removal.
   * Vascular complications monitoring scales will be assessed by using tool III for five times starting immediately after sheath removal.
3. Evaluation phase This phase aims to investigate the effect of changing angle of bed on pain severity and vascular complications for both groups.

Eligibility Criteria:
Inclusion Criteria:

Adult patient ≥ 18 years old of both sexes.

* Conscious patients admitted to the CCU after diagnostic or therapeutic cardiac catheterization.
* Patients who will have femoral artery catheterization.
* Patients who will have normal prothrombin time and partial thromboplastin time.

Exclusion Criteria:

* Patients who have previous surgery in the iliac or femoral artery.

  * Patients who have chronic back pain.
  * Patients who have an active bleed¬ing, hematoma and ecchymosis from insertion site prior to the sheath withdrawal.
  * Patient who take anti-coagulant drugs and analgesic therapy within the previous 24 hours before the procedure.
Molecular Analysis of Blood Samples in Standardized Cancer Care Referrals for SCAN and CUP

Patients with suspected cancer (SCAN) and cancer of unknown primary tumor (CUP) are vulnerable because the investigation is difficult and expensive and have poor prognosis because few effective established curative treatments are available. Great progress has been made, for example through highly qualified and systematic clinical investigations not least within the framework of the standardized care processes. However, there is a need for faster, less invasive and more cost-effective tests to confirm or exclude the diagnosis of carcinoma (epithelial cancer), primarily for SCAN and secondly for CUP, and partly to receive suggestions for localization of the primary tumor for primarily CUP and secondly SCAN. There is also a need for prediction of molecularly targeted therapies.

New research provides opportunities for using a blood test to acquire detailed and updated information about the individual patient's disease and thus also open new opportunities for faster, less invasive and more cost-effective diagnosis and prediction of molecularly targeted treatments based on individualized sampling and molecular stratification. It is important that these opportunities are tested in a timely fashion in practical health care, so the new opportunities can be taken advantage of and developed in the best way. The aim is to establish a new "best practice" for these hard-to-study and difficult-to-treat patients.

Samples will be taken of epithelial cells circulating in the blood, and of the free circulating DNA.

As a reference, germ-line DNA will also be sampled, also from regular blood samples.

The analyses will show whether the cellular and molecular tests can work in the existing standardized care processes for SCAN and CUP, or if adaptations in routines, training or equipment need to be introduced.

The analyses will also give an indication of whether the cellular and molecular sample analyses provide practically useful information for confirming or refuting the diagnosis of cancer, suggesting from which organ the cancer originated and for predicting individualized therapies, and whether adaptations in routines, training or technology need to be introduced.


Eligibility Criteria:
Inclusion Criteria:

* 200 patients who were referred to be investigated and diagnosed at the Diagnostic Centre (DC) in Södertälje, Sweden, for suspected cancer (SCAN) with serious non-specific symptoms with signs of cancer, or with suspected cancer of unknown primary (CUP) and which give informed consent to participate in the study.

Exclusion Criteria:

* All patients who have been referred and consented are included.
Effect of Muscle Strengthening Training with Pilates Reformer on Overweight/obese and Normal Body Weight Women (PRET)

This study investigates the physiological responses and the metabolic burden of a Pilates Reformer strength training session in physically inactive premenopausal women with a body mass index of 18-24.9 and 25.01-39.9. The sample included 20 women divided into two groups: 10 with normal weight (NW) and 10 with overweight/obesity (OB). In a non-randomised control design, the participants will perform a 60-minute muscle-strengthening session with Pilates Reformer equipment.

Pilates Reformer (PR) is one of the most popular types of exercise worldwide and is considered a gentle and safe method for untrained and overweight people. The PR training approach has been found to contribute positively to various health conditions (vascular function, blood pressure, physical fitness, musculoskeletal problems), improving the quality of life and mental well-being of the participants. At the same time, it seems that it can have a positive effect on the lipid profile and other biochemical markers such as insulin and fasting glucose. Furthermore, muscle strengthening training with PR equipment provides better levels of mobility, increasing active range of motion, and also provides greater pelvic and trunk stability for both adult and middle-aged participants.

This study is designed to investigate the physiological and metabolic burden of a muscle-strengthening session with PR equipment in 20 pre-menopausal and physically inactive women with a body mass index (BMI) of 18-24, 99 \& 25.01-39.9, as well as to determine the contribution of energy systems (mitochondrial, glycolytic) during and after the exercise. Each training session will last approximately 60 minutes, will be led by at least one trainer, and will include a warm-up of 7-10 minutes, muscle strengthening and mobility exercises of 35 minutes, and a recovery of 5 minutes. Anthropometric indicators, dietary intake, resting heart rate, blood lactate, resting metabolic rate, muscle soreness, rate of perceived exertion, blood pressure, and performance measurements will be measured at baseline. The metabolic cost during PR training session will be estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and excess post-exercise oxygen consumption measurements using a portable gas analyzer. After the PR training session will be measured the rate of perceived exertion, blood pressure, blood lactate, and muscle soreness levels.

Eligibility Criteria:
Inclusion Criteria:

* Be approved for participation by an orthopedist and internist
* Have not followed any diet or nutritional supplements for weight loss in the last six months before the study
* The group with overweight/obesity will consist of women with a body mass index of 25.01 - 39.9 kg/m2
* Be physically Inactive in the last six months before the study.

Exclusion Criteria:

* Musculoskeletal injury
* Weight loss\>10% in 6 months
* \<20 years
* \>50 years
* Μenopause
* Chronic diseases
* Use of alcohol, caffeine and any type of ergogenic supplements or medication during the study
* Physically active.
Expanded Access for Treatment With Imetelstat

The objective of this expanded access protocol (EAP) is to provide access to treatment with imetelstat, the Investigational Product (IP), for eligible adult participants diagnosed with very low, low, intermediate risk (by Revised International Prognostic Scoring System, IPSS-R) myelodysplastic syndromes (MDS) who are red blood cell (RBC) transfusion-dependent, have failed to respond or have lost response or are ineligible for ESAs, had not received prior treatment with either a hypomethylating agent or lenalidomide and were non-del(5q), until such time that imetelstat becomes commercially available.


Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of MDS according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and/or biopsy preferably within 24 but no more than 52 weeks prior to EAP start.
* Very Low, Low, or Intermediate risk MDS (≤3.5) per IPSS-R.
* Red blood cell (RBC) transfusion dependent, defined as requiring at least 4 RBC units over an 8-week period during the 16 weeks prior to EAP entry; pre-transfusion hemoglobin (Hb) should be less than or equal to 9.0 grams per deciliter (g/dL) to count towards the 4 units total.
* Has MDS that has failed to respond or has lost response or are ineligible for ESAs.
* To ensure participants have adequate iron stores they must have transferrin saturation greater than 20% and serum ferritin greater than 400 nanograms per milliliter (ng/mL).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
* Hematology and biochemical laboratory test values within the protocol defined limits.
* Have no approved alternative treatment available.
* Inability to participate in a current imetelstat clinical study for the disease or conditions.
* Have a treating physician who has appropriately evaluated the benefit/risk profile for potential imetelstat treatment.

Key Exclusion Criteria:

* Have previously assessed as having IPSS-R high or very high risk MDS.
* Participant with del(5q) karyotype.
* Participant with MDS/myeloproliferative neoplasm Overlap Syndromes.
* Participant has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients.
* Participant has received an experimental or investigational product or used an invasive investigational medical device within 30 days prior to EAP entry or is currently enrolled in an investigational study.
* Prior treatment with imetelstat; or eligible for enrollment in an ongoing imetelstat clinical trial.
* Prior treatment with lenalidomide or a hypomethylating agent (example, azacitidine, decitabine, or decitabine/cedazuridine).
* Has received an ESA or any anti-MDS therapy, chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to EAP entry.
* Prior history of hematopoietic stem cell transplant.

Note: Other protocol specified inclusion/exclusion criteria may apply.
SHR-1210 Plus Apatinib in Patients With Hepatocellular Carcinoma After Surgery

SHR-1210 is a humanized anti-PD1 Immunoglobulin G4 (IgG4) monoclonal antibody. This is an open- label，single center ，non-randomized ，Single Arm Exploratory Study . This clinical study is an investigator-initiatedclini-cal trial（IIT ）.The objective of this study is to evaluate the efficacy and safety of adjuvant therapy with anti-PD-1 antibody SHR-1210 and apatinib in patients with Barcelona Clinic Liver Cancer (BCLC) B\&C stage hepatocellular carcinoma after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or femal.
2. Hepatocellular carcinoma confirmed by histopathology, Child-Pugh A .
3. BCLC staging is stage B or C, preoperative assessment of no extrahepatic metastases.
4. ECOG Performance Status 0-1.
5. Alpha-fetoprotein (AFP) decreased to normal，3-4 weeks after surgery. If it is not normal, it must be checked that there is no clear lesion in MRI or CT.
6. Adequate organ function.
7. Patient has given written informed consent.

Exclusion Criteria:

1. No anti-tumor treatment for hepatocellular carcinoma, including chemotherapy and topical treatment, before surgery.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Tumors are not completely removed, or postoperative pathology suggests non-hepatocellular carcinoma or other malignant components;
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in- charge.
FLXfit Post Market Outcome Study Protocol

This investigation will provide safety and effectiveness information on the use of the FLXfit™ Cage. Data will be used for Post Market follow-up of the FLXfit™ system by evaluating:

* Safety as measured by the rate of serious operative and post-operative complications.
* Patients' quality of life, measured by health-related quality of life questionnaires up to 24 months following the procedure, as compared to patient's baseline.

Interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. Patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should be skeletally mature and have completed six months of non-operative treatment

Eligibility Criteria:
Inclusion Criteria:

* Adult (age 18 - 70 years) patient (male or female) with the following conditions of the lumbar spine as confirmed by advanced imaging (CT or MRI), who is a candidate for primary spinal fusion procedure according to acceptable criteria for such medical conditions:

  * Degenerative disc disease
  * With up to Grade I spondylolisthesis
* Failure of at least 6 month conservative treatment BMI \< 40.
* Patient to approve no pregnancy during the 24 months of study and no participation in other studies in parallel to this one.

Exclusion Criteria:

* This device is not intended for cervical spine use. PI may exclude patient from study

Contraindications include, but are not limited to:

* Infection, local to the operative site
* Signs of local inflammation,
* Fever or leukocytosis,
* Morbid obesity,
* Pregnancy,
* Mental illness,
* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or congenital abnormalities, fracture local to the operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count,
* Suspected or documented allergy or intolerance to implant's materials,
* Any case not described in the indications,
* Any patient unwilling to cooperate with postoperative instructions.
* These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
* Any case where the implant components selected for use would be too large or too small to achieve a successful result.
* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
* Prior fusion at the level to be treated.
Study to Evaluate Tetanizing Burst Therapy in Patients Undergoing ICD Replacement

This study evaluates whether the addition of tetanizing burst therapy reduces the pain associated with ICD shocks

The implantable cardioverter defibrillator is a device designed to rescue patients from life-threatening arrhythmias by delivering a defibrillation shock to allow restoration of cardiac rhythm. These defibrillation shocks are extremely painful, owing to sudden rapid contraction of thoracic and abdominal skeletal muscle, which, in addition to the heart, are stimulated by the defibrillation shock. Tetanizing Burst Therapy is a novel electrical waveform which tetanizes skeletal muscle with a brief burst of stimulation prior to the ICD shock, thereby reducing muscular contraction due to the shock. This study is designed for those patients who are already undergoing ICD replacement.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female age 18-80 years, inclusive
* Ability to understand and provide written informed consent
* Normal sinus rhythm
* Standard transvenous left-sided ICD referred for device replacement due to end of battery life

Exclusion Criteria:

* Heart rate \<40 or \>90 bpm
* Atrial fibrillation or pacemaker dependent
* NYHA Class III/IV symptoms of HF
* MI within 90 days of enrollment
* Severe cardiac ischemia manifested by chest pain at rest or with minimal exercise
* History stroke or TIAs
* History of prior ICD pocket infection
* ICD lead resistance that is too high or too low in the opinion of the investigator
* Female who is pregnant or breastfeeding
* Prior heart transplant
* Serum electrolytes out of normal range at participating institution
Effectiveness of Vestibular Electrical Stimulation in Vestibular Rehabilitation

This study aimed to evaluate the effectiveness of the vestibular rehabilitation program applied to patients with chronic unilateral vestibular hypofunction and the vestibular electrical stimulation applied to the trapezius muscles and cervical paravertebral muscles along with the rehabilitation program.

This study included 40 patients with unilateral vestibular hypofunction findings, aged between 18 and 65, and whose unilateral vestibulo-ocular reflex (VOR) gain for any semicircular canal was below 0.7 based on the video head impulse test (vHIT) test, were randomized into two groups. While one group underwent a supervised vestibular rehabilitation program for 4 weeks, the other group received 80 Hz high frequency transcutaneous vestibular electrical stimulation (VES) in addition to the supervised vestibular rehabilitation program. The treatment was applied to each group, 3 days a week, for a total of 12 sessions. Detailed musculoskeletal system examinations and vestibular system examinations of the included patients were performed, and sociodemographic characteristics (age, gender, body mass index (BMI), education level) were recorded. Both groups were tested before treatment and at the end of the 4th week, Dizziness Disability Inventory (DHI), Visual Analogue Scale (VAS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Activity-Specific Balance and Confidence Scale (ABCs), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and Static Posturography.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Patients who were evaluated by a Neurologist, Physical Medicine and Rehabilitation Specialist and otorhinolaryngologist and diagnosed with chronic unilateral vestibular hypofunction and have findings of chronic unilateral vestibular hypofunction
* Patients whose VOR gain for any unilateral semicircular canal based on vHIT test is below 0.7
* Patients who volunteered to participate in the study and signed the consent forms

Exclusion Criteria:

* Existing neurological or mental disorders
* Patients using vestibulosuppressant drugs
* Stroke, head trauma and other neurological diseases
* Patients with a history of brain surgery
* Patients with severely limited neck joint range of motion (those with a limitation of 45 degrees or more)