cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Different Nerve Stimulation Methods in Individuals With Chronic Constipation

Constipation is the most common digestive complaint in the general population. Normal stool frequency ranges from at least three times a week to a maximum of two times a day. Constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and dyssynergic defecation disorders.

In chronic constipation, treatment should be directed towards the underlying cause. In the treatment of chronic constipation, lifestyle changes and physiotherapy are in the first place, pharmacological treatment is in the second place, and surgical treatment is in the third place. Physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.

Eligibility Criteria:
Inclusion criteria:

•Being diagnosed with chronic constipation

Exclusion criteria:

* Metabolic diseases
* Severe heart or kidney disease, previous gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy,
* Neurological diseases such as multiple sclerosis, stroke, Parkinson's disease or spinal injury, impaired awareness
* Mini-mental score \< 15
* Legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating pattern of constipation and diarrhea.
Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage could be adjusted (2.5\~.75 mg/day) to maintain platelet counts 50\~250×109/L


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of ITP ≥6 months;Platelets \<30×109/L.
2. No evidence of other causes of thrombocytopenia.
3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
4. Previous therapy for ITP including rescue must have been completed at least 2 weeks prior to randomization.
5. Subjects treated with maintenance immunosuppressive therapy must be receiving a dose that has been stable for at least 1 month.
6. PT result no exceed normal by more than ±3s,APTT result no exceed normal by more than ±10s.
7. Signed informed consent.

Exclusion Criteria:

1. Patients with any prior history of arterial or venous thrombosis，or diagnosis as Thrombophilia.
2. Subjects diagnosed with tumor.
3. Have pre-existing cardiac disease within the last 3 months.No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.
4. Female subjects who are nursing or pregnant at screening or pre-dose on baseline.
5. Subjects who have previously received eltrombopag or any other thrombopoietin receptor agonist within 30 days .
6. Subject has consumed aspirin, aspirin-containing compounds, salicylates, anticoagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for \>3 consecutive days within 2 weeks of the study start and until the end of the study.
7. Any laboratory or clinical evidence for HIV infection.Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening.
8. ALT\> 1.5 x upper limit of normal (ULN), AST\> 3 x upper limit of normal (ULN)) DBLI\> 1.2 x upper limit of normal (ULN),Scr\> 1.2 x upper limit of normal (ULN)
9. The subject has participated in other clinical trial within the 3 months prior to randomization.
A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization

The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.

One of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. For coronary artery bypass grafting (CABG), the great saphenous vein (VSM) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of CABG. Long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery.

External support minimizes pathophysiological processes in the graft. For example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. In this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.

Eligibility Criteria:
Inclusion Criteria:

* elective cardiosurgical revascularization using VSM vein graft, i.e. patients with MVD findings.

Exclusion Criteria:

* thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. A relative contraindication for exclusion from the study is: VSM varicosity, VSM damage during sampling.The age, gender or weight of the patient has no influence on the indication.
Prognostic Factors for Ablation of Atrial Fibrillation

The aim of the study is to find factors associated with sinus rhythm maintenance after catheter ablation for atrial fibrillation.

Catheter ablation presents the most effective kind of treatment for atrial fibrillation (AF). However, its efficacy is still limited, and AF reoccurs in approx. 30% of patients during the first year after ablation.

Several factors associated with AF recurrences were found, such as dilated left atrium, higher age, or the duration of AF before the ablation. As it was shown, the detailed analysis of the ECG before the ablation could also serve several important factors that could predict AF reoccurrence.

In the study, all participants who will be referred for AF ablation in the study center will be enrolled. Pre-procedural ECG on the day of the ablation (just during the procedure) will be analysed using several methods: 1) spectral analysis (dominant AF frequency will be determined), 2) heart rate variability (for time and frequency domain analysis), 3) vectorcardiography. All ECG recordings will be analyzed using matlab software.

All participants will have regular follow-up checks at 3, 6, and 12 months after ablation including 24-hour Holter recordings. Based on the rhythm presence during the follow-up, participants will be divided in two groups: 1) AF group (patients with AF recurrences) and 2) sinus rhythm (SR) group (patients without AF reoccurrence during follow-up). AF reoccurrence will be determined at a presence of AF or any other atrial tachycardia lasting \> 30 sec. The results of pre-procedural ECG analysis will be compared between both groups. Logistic regression will be done to determine optimal combination of parameters associated with AF freedom.

Eligibility Criteria:
Inclusion Criteria:

* atrial fibrillation

Exclusion Criteria:

* absent of informed content
Efficacy of Balance Training in Patients With Rotator Cuff Disease

The purpose of the study is to determine whether balance training is effective in patients with rotator cuff disease.


Eligibility Criteria:
Inclusion Criteria:

* Verification of the diagnosis of rotator cuff disease by a medical practitioner via radiological techniques.
* Pain due to unilateral rotator cuff disease at least four weeks.

Exclusion Criteria:

* Systemic pathology including inflammatory joint disease.
* More than %50 restriction of passive range of motion in two or more planes.
* History of major surgery on the lower extremities and shoulder regions.
* Acute or chronic pain in the spine or lower extremities.
* An injury of the lower extremities during the last six months which affected functional capabilities.
* Any kind of neurological complaint.
* Cardiovascular diseases which affect balance.
* Acute dizziness
* Medications which affected balance
* Subjects who performed balance training
Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

The purpose of this study is to investigate how effective the study drug IPI-549 is against types of cancers. IPI-549 is considered experimental because it is not approved by the US Food and Drug Administration (FDA) for the treatment of cancer.

Patients will be treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

This is a phase 2 window of opportunity trial in patients with locally advanced head and neck cancer. A key objective is to provide the first proof that macrophage phenotype switching can be accomplished in humans and lay the groundwork for future trials of this novel approach to immune therapy. Patients who are candidates for surgical resection will be enrolled and treated with 2 weeks of IPI-549, a specific PI3Kγ inhibitor. Tumor tissue for research purposes through core biopsies will be obtained prior to initiation of IPI-549 and at surgery.

The study team hypothesizes that mRNA signatures of immune response will be increased in IPI-549-treated patients. For the efficacy endpoints, RECISTv1.1 will be used.

Eligibility Criteria:
Inclusion Criteria:

* Have locally advanced that is amenable to surgical resection
* Must be able to swallow tablets
* Must be able to undergo a core tumor biopsy.
* Must have adequate organ function.

Exclusion Criteria:

* Diagnosis of cutaneous squamous cell carcinoma (SCC) or Epstein-Barr virus (EBV) related nasopharynx cancer.
* Planned major surgery within 4 weeks prior to initiation of study drug
* Patients treated with chemotherapy, biologic therapy, or other investigational agent within \< 28 days of starting study drug
* History of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus (HCV)
* On going treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids
* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g. gastric bypass surgery, gastrectomy)
* Female subjects who are pregnant or breastfeeding
* Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
Assessment of Shoulder Rehabilitation Practices and Documentation Protocols at Riphah Rehabilitation Center

This study aims to evaluate Riphah Rehabilitation Center's shoulder rehabilitation procedures and documentation guidelines. The study will specifically assess the efficacy of shoulder rehabilitation procedures, their methodology, and the techniques employed to record patient improvement. In order to make sure the centre adheres to best practices, improves patient care, and keeps accurate records for better treatment outcomes, the study intends to identify areas of strength and potential improvements in both the rehabilitation techniques and documentation processes. The evaluation's findings will improve the center's operational effectiveness and clinical practices.

Target Audience:Healthcare Professionals (such as physicians, physiotherapists, and rehabilitation therapists): This study will assist guide evidence-based strategies for managing shoulder injuries and offer insights into contemporary rehabilitation procedures.

Centre Administration: For better patient care, resource management, and operational efficiency, the results will point out areas where documentation and treatment protocols should be strengthened.

Patients and Families: In the end, the study will improve rehabilitation results, increasing the likelihood that patients will heal from shoulder injuries more quickly and completely.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing shoulder rehabilitation at Rphah Rehabilitation Center.
* Rehabilitation protocols implemented within the center.
* Documented cases with sufficient information for analysis.
* Both acute and chronic shoulder conditions

Exclusion Criteria:

* Patients with shoulder conditions not requiring rehabilitation.
* Cases lacking adequate documentation.
* Rehabilitation protocols not specific to shoulder conditions.
* Patients with comorbidities significantly affecting rehabilitation outcomes.
Patient Specific Instrumentation in TKR

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

This is a randomised control trial to assess the benefits of using patient specific instrumentation in total knee replacement surgery. Patient specific instrumentation is an individualised system for total knee replacement surgery. The system has been marketed and is already in use in some centres. The process is similar to traditional knee replacement surgery but approximately 6 weeks prior to the operation patients will undergo an MRI scan of their knee, hip and ankle. From this data the dimensions and rotation of the knee can be accurately measured, and a custom made jig can be made specific to that patients anatomy. The jig is used intra-operatively to make accurate bone cuts according to this pre-operative plan, the type of implant used remains the same but the sizing of the components, and alignment of the implant is expected to improve. This study assesses any improvement in implant alignment in using the patient specific instrumentation, any improved intra-operative outcomes and any long term clinical outcome improvements for patients.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-75 years at time of surgery.
* Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the knee.
* Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme.
* Patients who signed the study consent form prior to surgery.

Exclusion Criteria:

* Pregnant women.
* Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems.
* Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition.
* Previous knee surgery including those already treated by with a total knee replacement (i.e. requiring a revision knee replacement).
* Muscle contracture around the knee joint
* Individuals with active or suspected infection or sepsis.
* Patients with contraindication to MRI
Effects of Scalp Nerve Blocks on Systemic Inflammation

Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.

Exclusion Criteria:

* previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial
A Study to Determine if Caffeine Accelerates Emergence From Anesthesia

At present clinicians have no way to reverse anesthesia. Patients wake when their bodies clear the anesthetic. Most people wake quickly, but some do not. All patients have memory and other cognitive problems after waking from anesthesia. In studies on animals, the investigators observed that caffeine caused rats and mice to wake much more rapidly from anesthesia. This was true for all the animals tested. The investigators would like to see if this holds true in humans. Will caffeine accelerate waking from anesthesia? Will it reverse the cognitive deficits associated with anesthesia, after waking?

The investigators carried out a modest trial with 8 test subjects. Each volunteer was anesthetized twice. Each volunteer was anesthetized one time and received an infusion of saline (placebo control), without the aid of any other drugs and the other time the volunteer received an infusion of a relatively low dose of caffeine. The order of saline versus caffeine was randomized and the study was done in a double blind manner. We observed that emergence from anesthesia was significantly accelerated by the caffeine infusion. No adverse events were observed.


Eligibility Criteria:
Inclusion Criteria:

1. Age 25-40.
2. Male.
3. Normal healthy subject without systematic diseases or conditions.
4. Metabolic Equivalents of Functional Capacity \>= 5.
5. Low risk for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA
6. No History of Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases.
7. BMI \< 30 kg/m2.
8. No history of prior difficulty with anesthesia.
9. No personal or family history of malignant hyperthermia.
10. No history of any mental illness.
11. No history of drugs or alcohol abuse (urine drug screens required).
12. Subjects capable of giving consent.
13. Living less than 30 miles away from University of Chicago.
14. No history of seizure disorders.
15. No history of head trauma.

Exclusion Criteria:

1. Age \<25 or \>40.
2. Female.
3. ASA physical status \> 1 (normal healthy subject without systematic diseases or conditions)
4. Metabolic Equivalents of Functional Capacity (METs) \< 5.
5. High risks for Obstructive Sleep Apnea (OSA) based on the screening test (STOP-bang score established by American Society of Sleep Apnea): Yes to \> 3 items- high risk of OSA
6. History Arrhythmia (Baseline EKG will be obtained during the history and physical session), seizure, liver and kidney diseases
7. BMI\>30 kg/m2.
8. Prior difficulty with anesthesia.
9. Personal or family history of malignant hyperthermia.
10. History of any mental illness.
11. History of drugs or alcohol abuse (urine drug screens required)
12. Subjects capable of giving consent
13. Living more than 30 miles away from University of Chicago.
14. History of seizure disorders.
15. History of head trauma.
Housing, Environment, And Living Conditions for Transformed Health

This project will compare the health effects of public housing renovation, neighborhood built and social environment improvements, and indoor air purification, alone and in combination, as well as the cost effectiveness of each approach.

STUDY 1: The study will assess the effects of public housing and neighborhood environment (built and social) improvements on health-related behaviors, psychosocial and physiologic stress, and self-reported and physiological markers of lung health and chronic disease.

STUDY 2: The study will determine whether indoor air purification can positively impact lung health in public housing sites not undergoing housing renovation, comparing a site near industrial pollution vs one less contaminated.

Participants will complete surveys, physical exam, lung function tests, and blood draw. An indoor air purifier with a usage tracker and an indoor air quality monitor will be provided, and used filters will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years and older
* English speaking
* Residents of one of 4 public housing site in Birmingham, Alabama

Exclusion Criteria:

* Individuals who are not 18 years or older
* Do not speak English
* Do not meet the residency criteria
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.


Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

* History of serious disease.
* History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
* Known or suspected impairment/alteration of immune function.
* Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.

For additional entry criteria, please refer to protocol.
ATEZOLIZUMAB - BEVACIZUMAB in the Treatment Hepatocellular Carcinoma Inoperable or

Evaluation of the efficacy and safety of the combination ATEZOLIZUMAB - BEVACIZUMAB in the treatment of locally advanced inoperable or metastatic hepatocellular carcinoma in Finistère

Patients treated by ATEZOLIZUMAB and BEVACIZUMAB for an Advanced hepatocellular carcinoma will be followed to observed their safety and the efficacy of this treatment, and to identify prongnosis factors

Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma locally advanced or metastatic, non able to be resectable, with no prior systemic treatment
* Child Pugh A and ECOG 0 or 1
* upper digestiuve endoscopy less than 6 months, if esophageal varcices : must be treated
* non eligible to receive a locoregional therpay or progressive after this kinf of treatment
* with informed consent

Exclusion Criteria:

* refuse to participate
* under legal protection
* exclusion criteria from the tempory utilisation authorization
GMP Drink for PKU Study

This study will evaluate the safety, gastrointestinal (GI) tolerance, acceptability and compliance of a Glycomacropeptide-based protein substitute for patients with Phenylketonuria (PKU).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Over 3 years of age
* Diagnosed with classical or variant type phenylketonuria
* Have been compliant in taking at least one amino acid-based, Phe-free protein substitute, providing at least 20g protein equivalents, for at least 1 month prior to trial commencement
* Have a prescribed daily Phe allowance
* Written informed consent from patient, or from parent / carer if applicable

Exclusion Criteria:

* Currently prescribed Sapropterin or similar tetrahydrobiopterin based medication
* Pregnant or lactating
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients, including milk protein or soya
* Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements