cyrilzakka/clinical-trials huggingface dataset:
The Influence of Manual Therapy in the Quality of Life in Tension-Type Headache

The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques. The study design involved a factorial, randomized, double-blind, controlled study

Object: The present study aims to assess the quality of life of patients suffering from tension-type headache (TTH) treated for 4 weeks with different manual therapy-based techniques.

Methods: The study design involved a factorial, randomized, double-blind, controlled study of 76 subjects. They were divided into 4 groups: suboccipital inhibitory pressure was applied to the first group; suboccipital spinal manipulation was applied to the second group; a combination of the two treatments was applied to the third group; and the fourth group was a control group. Quality of life was assessed using the SF-12 questionnaire (both overall and in its different dimensions) at the beginning and at the end of treatment, and after one month as a follow-up.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by a neurologist, with headache characteristics as established by the International Headache Society and Controlled pharmacologically.

Exclusion Criteria:

* Patients with infrequent ETTH, or with probable frequent and infrequent forms of TTH They can never have vomiting or headache episodes during the treatment ETTH patients may experience very occasionally photophobia or phonophobia during their episodes of headache, CTTH patients may experience very occasionally photophobia, phonophobia or mild nausea during headache episodes. Pain aggravated by movement of the head, Metabolic or musculoskeletal problems with similar headache symptoms, Previous trauma to the cervical spine, Active vertigo history Poorly controlled hypertension, Joint stiffness, atherosclerosis, or advanced osteoarthritis, Patients undergoing pharmacological adaptation, Excessive emotional stress, Patients with heart devices Joint instability, Neurological disorders, Laxity of cervical soft tissues, Radiographic abnormalities Generalized hyperlaxity or hypermobility, Pregnancy.
Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib

This is a single center, four-treatment, four period, crossover study to evaluate the effect of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800 mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period at the end of the study. Each participant will receive all four treatments


Eligibility Criteria:
Inclusion criteria

* Healthy male or female subjects (postmenopausal women)
* Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria

* Smokers
* Subjects using any prescription drug or over-the-counter (OTC) medication (including herbal and alternative medication) within 2 weeks prior to dosing.
* Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
* A past medical history or presence of clinically significant ECG abnormalities including:
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of medications pre-disposing the subjects for GI bleedings/cerebral hemorrhage.
* Women taking any biphosphonates (Fosomax like drugs)
* History of being immunocompromised, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Females nursing infants. Other protocol-defined inclusion/exclusion criteria may apply.
HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer

The purpose of this study is to evaluate the efficacy and safety of HR070803 in Combination With Oxaliplatin plus Tegafur compared to HR070803 in combination with oxaliplatin, 5-fluorouracil/leucovorin (5FU/LV) treatment as adjuvant therapy in patients with resected pancreatic cancer.

STUDY DESIGN/ Evaluation criteria Main criterion: efficacy. The main criterion is the 1-year disease-free survival rate. Disease-free survival is defined as the time from date of randomization until the date of the first cancer-related event, second cancer, or death from any cause. Patients without event at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria include Overall survival. OS is defined as the time from date of randomization until the date of death from any cause. Patients who are still living at the time of analysis will be censored at the date of last follow-up visit.

Secondary criteria also include the Disease-free survival.

Tolerance Patients evaluable for toxicity must have received one investigational drug.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic complete resection (R0 and R1).
2. ECOG performance status 0 or 1.
3. Life expectancy of greater than or equal to 6 months.
4. Full recovery from surgery and patient is scheduled to start treatment within 3 weeks to 12 weeks after surgery.
5. The number of lymph nodes dissected during resection ≥ 15.
6. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Patients with pancreatic cancer originating from extrapancreatic ductal epithelium, including pancreatic neuroendocrine carcinoma, acinar cell carcinoma of the pancreas, pancreatoblastoma, and solid-pseudopapillary tumor;
2. Presence of or history of metastatic or locally recurrent pancreatic adenocarcinoma.
3. CA19-9 exceeding normal value within 14 days prior to enrollment.
4. Prior neo-adjuvant treatment, radiation therapy, or systemic therapy for pancreatic adenocarcinoma.
5. Severe infection (\> CTCAE grade 2), such as severe pneumonia, bacteremia, infection complications, etc. requiring inpatient treatment, occurred within four weeks before enrollment, and symptoms and signs of infection requiring intravenous antibiotic therapy (except for prophylactic antibiotics) occurred within two weeks before enrollment;
6. Patients with cardiac clinical symptoms or diseases that are not well controlled, such as: (1) Patients with NYHA class 2 and above cardiac failure; (2) unstable angina; (3) myocardial infarction that occurred within 6 months; (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Perceived Fatigue in Persons With Multiple Sclerosis (PwMS)

The study investigates the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls. The study extends over a four session period, each session lasting maximally 1h30 minutes The experimental conditions include participants walking to music and metronome (at different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes in between each condition. Non-invasive equipment will be used. participants are equipped with sensors (watch-like straps at the wrists, ankles and across the chest) and are given wireless headphones.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MS of \>1 year,
* no relapse in the last 1 month,
* ability to walk for 12 minutes without interruption,
* an average usual walking speed between the range of 0.4 and 1.2 m/s.

Exclusion Criteria:

* cognitive impairment hindering the understanding and execution of the experimental procedures
* pregnancy
* hearing impairment
* amusia
* beat deafness
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer

This study is being done to:

* test the safety of OTL38
* see if OTL38 helps light up the cancer when viewed with the special camera system
* test the safety of the special camera system for use along with OTL38 during surgery


Eligibility Criteria:
Inclusion Criteria:

1. Female patients 18 years of age and older
2. Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary debulking or interval debulking surgery, and:

   * Who are scheduled to undergo laparotomy for the debulking surgery OR
   * Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery, if cancer is detected on the laparoscopy
3. A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
4. Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
5. Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

1. Previous exposure to OTL38
2. Known FR alpha-negative ovarian cancer
3. Planned surgical approach via laparoscopy or robotic surgery
4. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
5. History of anaphylactic reactions or severe allergies
6. History of allergy to any of the components of OTL38, including folic acid
7. Pregnancy, or positive pregnancy test
8. Clinically significant abnormalities on electrocardiogram (ECG)
9. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
10. Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
11. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
12. Known Stage IV ovarian cancer with Brain Metastases
13. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
14. Known sensitivity to fluorescent light
To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients.

A two arm open label multi-centered randomized interventional trial is proposed to assess aspects of safety and efficacy of Nuvastatic™ (Serial No: C5OSEW5050ESA) . Two parallel groups of (1:1) ratio comparing Nuvastatic™ versus standard care will be conducted on patients on oxygen saturation (SaO2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (PaO2:FiO2) at or below 300 mg Hg.

Primary Outcome Measures: time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first.

Secondary Outcome Measures: Clinical status as assessed with the seven-category ordinal scale on days 7 and 14, mortality at day 28.

1. The duration of mechanical ventilation.
2. The duration of hospitalization in survivors.
3. The time (in days) from treatment initiation to death.
4. Virologic measures included the proportions with viral RNA detection over time and viral RNA titer area under-curve (auc) measurements.

This study will propose Nuvastiatic™ as a new lead therapeutic agent for SARS-CoV-2, and new insights for currently ongoing clinical trials to treat SARS-CoV-2 infections. Nuvastatic™ could be used as potential anti-coronavirus therapy that acts on the human immune system or human cells as an immune modulator, and the other on coronavirus itself as an antiviral agent. In terms of the human immune system, the innate immune system response plays an important role in controlling the replication and infection of coronavirus, and interferon gamma, interleukins, Th cells, granulocyte macrophage are expected to enhance the immune response.

Eligibility Criteria:
Inclusion Criteria:

1. Male and nonpregnant female patients 18 years of age or older eligible if they had a diagnostic specimen that was positive on RT-PCR. -
2. For Mild - Moderate cases: Subjects who show positive for nasal swab test at screening using RT-PCR protocol for Covid 19.
3. For Severe cases - Has an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg.
4. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Patients who are allergic to this medicine
3. Patients allergic to content of study product
4. Patients with diabetes.
5. Patients accompanied by serious physical diseases of heart, lung, brain, etc.
6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
7. Patients who are not able to take drugs orally.
Corneal Topography in Vernal Keratoconjunctivitis

To evaluate the corneal topographic changes in VKC patients using Pentacam and prevalence of KC development in VKC.

Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, with seasonal periods of exacerbation.VKC is characterized by itching, photophobia. white mucous discharge, lacrimation, foreign body sensation, and pain due to corneal involvement of shield ulcers. Corneal involvement in VKC involves injury to the superficial and basal epithelial layers and anterior stroma . Excessive eye rubbing and a slow release of matrix metalloproteinases penetrate the cornea in presence of chronic epithelial damage causing astigmatism and corneal ectasia . These changes may be undetected until advanced complications such as keratoconus(KC) with thinning and protrusion of cornea leading to myopia and astigmatism . These changes can be measured accurately by corneal topography, making it the gold standard in the screening of keratoconus and other corneal ectasias . Corneal topography is a method of computer-assisted examination of the cornea in which multiple concentric light rings are projected on cornea. Changes in corneal topography indices to be studied include changes in effective refeactivepower ,asphericity , corneal asymmetry index and visual performance . It is a non-invasive exploratory technique to analyse both qualitatively and quantitatively the morphology of the cornea . The Penta Cam is a cornea and anterior segment topography device, based on a rotating Scheimpflug camera. Its optical cross-sectional analysis that helps in imaging of anterior and posterior corneal surfaces which provides with fullpachymetric map and many other data such as corneal aberrometry and densitometry that allow early detection of ectasia.

Eligibility Criteria:
Inclusion Criteria:

clinical diagnosis of vernal keratoconjunctivitis -

Exclusion Criteria:

patients with corneal disease as corneal opacity, corneal dystrophy or degenerative changes patients with previous corneal surgery patients with ocular trauma.

-
Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers

The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females healthy volunteers aged 18-65 years;
2. Written informed consent obtained before the first trial related activity.
3. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
4. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
5. Non- or ex-smokers who smoked \< 5 pack years;
6. Good physical and mental status;
7. Normal blood pressure and heart rate;
8. Electrocardiogram (ECG)considered as normal;
9. Results of laboratory tests within the normal ranges.
10. Lung function measurements within the normal ranges.

Exclusion Criteria:

1. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
2. Pregnant or lactating women or women of childbearing potential, UNLESS they are using one or more of the acceptable methods of contraception. Male subjects not willing to use an acceptable method of contraception.
3. Positive HIV1 or HIV2 serology;
4. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
5. Unsuitable veins for repeated venipuncture;
6. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
7. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
8. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;
9. Participation in another clinical trial less than 8 weeks prior to inhalation of the study medication; participation in another clinical trial using radioactive material within 1 calendar year;
10. History of hypersensitivity to M3 Antagonists or any of the excipients contained in any of the formulations used in the trial;
11. Any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital, isoniazid) preceding the first intake of the study drug, with the exception of occasional paracetamol (maximum 2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions).
12. Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).
13. Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to the first intake of study medication and for the entire duration of the study.
14. Heavy caffeine drinker.
Validation of the PreSchool Confusion Assessment Method for the Intensive Care Unit (psCAM-ICU)

The investigators hypothesize that critical care trained registered nurses and physicians can perform measurements of cognitive impairment in critically ill pediatric patients in a reliable and valid manner. To test this hypothesis, the investigators will incorporate an instrument (psCAM-ICU) to assess both components of consciousness, arousal and content, in critically ill pediatric patients at least 6 months to children 5 years of age, both on and off mechanical ventilation, and compare these assessments to those of the reference standard.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the Pediatric Critical Care Unit regardless of admitting diagnosis aged at least 6 months of age up to 5 years of age.
* Patients ventilated or non-ventilated.

Exclusion Criteria:

* Non-English speaking patients.
* Children with visual or hearing impairments.
* Patient/surrogate or physician refusal
* Moribund and not expected to survive \>48 hours
* Patients in whom comfort care orders have been instituted
* Patients who are identified for transfer to floor or home regardless of placed orders or bed availability
Pelvic Osteotomy in Bladder Exstrophy

The study focuses on the surgical treatment of bladder exstrophy, a congenital condition where the bladder is located outside the body. It examines the use of modified diagonal pelvic osteotomy combined with an external fixator as a treatment approach. This method aims to improve pelvic support and facilitate proper bladder reconstruction. The study likely evaluates the outcomes, complications, and overall effectiveness of this surgical technique in enhancing patient quality of life and functional results. Key findings may include insights into recovery times, rates of successful bladder closure, and potential long-term benefits for patients.


Eligibility Criteria:
Inclusion Criteria:

1. age: all cases of delayed exstrophy repaior
2. sex : both gender
3. children who received no operative treatment befor

Exclusion Criteria:

1. previous pelvic surgery
2. sever comorbidities
Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy

Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless, postoperative pain (PP) remains an issue of concern.

The reported incidence of PP after TLH ranges from 35 % to 63 %. The origin of PP after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. A prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. Methods to decrease the severity of PP are required before TLH can be confidently recommended.

Curcumin has several benefits, which are endorsed by the World Health Organization (WHO).

That is, it can be used to treat dyspepsia and peptic ulcer. Moreover, it has anti-inflammatory and analgesic properties. Most benefits are attributed to its anti-oxidant and anti-inflammatory effects. Curcuminoid is the active ingredient of turmeric. Curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. Further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.


Eligibility Criteria:
Inclusion Criteria:

-Laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates

* They should be able to understand and sign an informed consent
* They should be literate enough to understand the maintenance of a diary recording pain scores, QoL-15 scores, and any adverse event

Exclusion Criteria:

* Patients with any peripheral or central neuropathic pain

  * Patients used to taking over-the-counter painkiller pills
  * Patients with a history of alcohol intake/drug dependence
  * Patients with a history of psychosis

    \*Patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (NSAIDs)/painkillers
  * Patients on immunosuppressive/cytotoxic/steroid therapy. \*Patients with a known allergy to duloxetine