cyrilzakka/clinical-trials huggingface dataset:
A Small-group Intervention to Reduce HIV Sexual Transmission Risk Behavior Among HIV-positive Men Who Have Sex With Men

Gay Poz Sex (GPS) is an HIV prevention and sexual health promotion program for HIV-positive gay and bisexual men, which takes place in a group counselling format. All participants provided written informed consent at the outset of the study. Eligible participants filled out a 1-hour computer-assisted self-interview questionnaire. Subsequently, participants attended seven 2-hour group sessions, led by 2 peer facilitators, who were HIV-positive gay men, in groups of 5-8 men. Immediately and 3 months following the completion of the GPS program, participants were scheduled to attend a 1-hour session to complete the same questionnaire package. Participants received an honorarium and a list of community resources, including mental health or substance use counseling services, at the end of each assessment. Participants also participated in a program evaluation interview at the 3-month follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in the study, participants had to:

1. identify as male,
2. report engaging in condomless anal sex with another male during the past 3 months,
3. self-report an HIV-positive status,
4. be over the age of 18 years old, and
5. be able to speak and read in English.

Exclusion Criteria:

* Self-reported female gender,
* no condomless anal sex with another male during past 3 months,
* HIV-negative
Bipolar Hemostatic Forceps Versus Standard Therapy in Acute Non-variceal Upper GI Bleeding

Bipolar hemostatic forceps will be tested against standard therapy in active, non-variceal, upper gastrointestinal bleeding by a prospective, randomized trial

Patients with active, non-variceal, upper gastrointestinal bleeding usually need an urgent endoscopic treatment. The standard therapy by application of an hemoclip and/or injection of an epinephrine solution is not always successful. Bipolar hemostatic forceps is already being used successfully for the treatment of gastrointestinal bleeding in endoscopic submucosal dissection. Its use in primary endoscopic treatment of non-variceal, upper gastrointestinal bleeding has not been shown yet in a randomized prospective study. Patients with active, non-variceal, upper gastrointestinal bleeding (esophagus or stomach or duodenum) of any cause are randomized (1:1) in standard therapy by combination therapy using an hemoclip and/or injection of an epinephrine solution or experimental therapy by application of the bipolar hemostatic forceps. Cross over-treatment should be tried first in case of failed initial treatment. Rescue treatment by other methods such as application of an Over the Scope Clip (OTSC), angiographic embolization or surgery will be allowed next. All patients receive an additional standard therapy by proton pump inhibitors (PPI). Hypothesis: Endoscopic therapy by application of the bipolar hemostatic forceps is superior to standard therapy regarding technical success and rebleeding rate.

Eligibility Criteria:
Inclusion Criteria:

* Active, nonvariceal, upper gastrointestinal bleeding

Exclusion Criteria:

* Severe coagulopathy unresponsive to blood products transfusions: platelets \<20,000; international normalized ratio \>3.0; partial thromboplastin time \>2 normal
Danhong Injection in the Treatment of Acute Ischemic Stroke

The purpose of this study is to determine whether Danhong injection is effective in the treatment of acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Female or male inpatients
* Age: 18 - 70 years.
* Clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect. Ischemic stroke is defined as an event characterized by the sudden onset of an acute focal neurologic deficit presumed to be due to cerebral ischemia after CT scan excludes hemorrhage.
* Clinical diagnosis of "Xueyu Zheng" (Blood Stasis Syndrome) as the scores of Chinese medicine symptoms scales of "Xueyu Zheng" in ischemic stroke ≥ 20. The Chinese medicine symptoms scales of "Xueyu Zheng" is defined as following (1)hemiplegia-10,(2)numbness of limbs-10，(3) dark face-9,(4)purple or dark lip-8,(5)Roughness of skin-4, (6) pain with fixed point-5, (7) purple or dark tongue-10,(8)ecchymosis on tongue-10,(9)purple sublingual vessel-10,(10)varicose sublingual vessel-8,(11)unsmooth pulse-8,(12)intermittent pulse-1.
* Onset of symptoms in 1 week prior to initiation of administration of study drug.
* Clinical diagnosis of cerebral anterior circulation obstruction.
* 4≤NIHSS\<20.
* Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the subject's legally authorized representative or relatives, or deferred where applicable, according to the regulatory and legal requirements of the participating centers.

Exclusion Criteria:

* Evidence of intracranial hemorrhage (ICH) or other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the CT-or MRI-scan.
* Patients with thrombolysis or endovascular treatment.
* Known history of allergy or suspected allergic to the drug.
* Blood glucose 2.8 or \> 16.8 mmol / l under the treatment of diabetes or with severe complications due to diabetes (eg. peripheral neuropathy, diabetic gangrene).
* Liver function impairment with the value of ALT or AST over 1.5-fold of normal value.
* Renal dysfunction with the value of serum creatinine over 1.5-fold of normal value.
* Severe cardiac dysfunction on echocardiogram or the grade of heart function over Ⅲ grade.
* History of prior stroke with mRS ≥2.
* Complicated with atrial fibrillation.
* Severe stroke as assessed by appropriate imaging techniques (eg. massive cerebral infarction including more than one lobe of brain or over 1/3 of blood-supply area of middle cerebral artery).
* Prior disable patients.
* Hemorrhagic tendency or recent severe or dangerous bleeding in 3 months.
* Suspected addicted into alcohol or drug abuse.
* With severe complications that would make the condition more complicated assessed by the investigator.
* Woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months.
* Woman who is under menstrual period.
* Patient who is participating in other trials or has been participated in other trials in recent 3 months.
Stereotactic Radiotherapy for Oligoprogressive ER+/HER- Metastatic Breast Cancer, a Prospective Phase 2 Study (Oligopro-Breast)

The Oligopro-Breast trial is a Phase II study targeting women with ER+/HER2- metastatic breast cancer who have been on endocrine therapy and/or CDK4/6 inhibitors for at least 6 months, and show progressive disease at 1-3 extracranial metastases, which are treatable locally. The trial aims to investigate if treating these resistant metastases with SBRT (or other local treatments if SBRT is not possible) can extend the use of the current systemic therapy.

Patients will continue their existing systemic treatment while receiving SBRT on all progressive lesions. If new oligoprogression occurs, SBRT will be performed again. A new systemic treatment line will start if there is polyprogression (more than 3 lesions at once), progression of more than 6 lesions over 12 months, intracranial progression, or lesions that cannot be treated locally.

The scientific question is whether local treatment of resistant metastases can prolong the effectiveness of ongoing systemic therapy, which is particularly beneficial if the treatment is well-tolerated. The primary objective is to measure the proportion of patients surviving without changing their systemic treatment line at 6 months after SBRT.

This trial is significant for patients as it explores a method to potentially extend the duration of effective and well-tolerated treatments, offering hope for better management of metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG performance status 0-2.
* Histologically confirmed ER+/HER2- MBC.
* History of polymetastatic disease. Patients with genuine oligometastatic disease and 1-3 oligoprogressive lesions are only allowed if ablative therapy of all metastases is deemed impossible.
* Under 1st to 2nd systemic treatment line with hormonotherapy and/or CDK4/6 inhibitors for at least 6 months before progression.
* Progressive disease at 1-3 extracranial sites.
* Ability to treat all progressive lesions locally according to the treating radiation oncologist.

Exclusion Criteria:

* Second malignancy if it is not in complete remission.
* Previous local treatment for oligoprogression under the current systemic treatment line
* Current progression in a lesion that has been treated with SBRT before and is not amendable for surgery or radiofrequency ablation (RFA).
* Progressive or newly diagnosed brain metastases. Known brain metastases that have been nonprogressive for at least 6 months, are not an exclusion criterion.
* Inability to continue the same ST line after local therapy (for example because of toxicity or patient refusal).
* Pregnancy.
* Inability to sign the informed consent.
Safety & Feasibility of Functional Electrical Stimulation for The Treatment of Premature Ejaculation

Prospective, non-randomized, controlled, single-center study, to evaluate the efficacy of applied nominal electrical stimulation parameters given to premature ejaculation (PE) patients in order to prolong the ejaculatory latency time which will eventually increase the quality of their sexual life.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Clinical history of premature ejaculation
* Familiar with self- stimulation
* Ability to follow study instructions and complete study assessment tools
* Washout period of two weeks

Exclusion Criteria:

* History of cardio-vascular disorders
* Any type of implanted pacemaker/defibrillator
* Hypertension
* Diabetes Mellitus
* Local dermatological disease
* Local skin irritation/ lesions
* Any neurological disorder
* Any psychiatric disease and/or any psychiatric medications
* Any neoplastic disease in the past two years
Multiple Escalating Oral Doses Study of PF-07081532 in Adult Participants With Type 2 Diabetes Mellitus

This is a randomized, placebo-controlled, double-blind (investigator- and participant-blinded), sponsor-open, dose-escalating study of PF-07081532 in patients with Type 2 diabetes on metformin (Parts A and C). The study may also enroll non-diabetic participants with obesity (Part B). Study participants will receive an investigational product or placebo every day for up to 28 days (Part A) or up to 42 days (Part B, optional; Part C, optional).

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple oral doses of PF-07081532 in participants with inadequately controlled T2DM on metformin and optionally in non-diabetic obese participants.


Eligibility Criteria:
Key Inclusion Criteria for participants enrolling with T2DM:

* Type 2 Diabetes treated with a stable dose of metformin at least 500 mg per day for at least 2 months prior to screening visit and use of no other medications for glycemic control.
* HbA1c value between 7.0% and 10.5%, inclusive.

Key Exclusion Criterion for participants enrolling with T2DM:

-Type 1 Diabetes or secondary forms of diabetes.

Key Inclusion Criterion for participants enrolling with obesity:

-Obese (as indicated by screening BMI) non-diabetic adults.

Key Exclusion Criterion for participants enrolling with obesity:

--Type 1 or Type 2 Diabetes or secondary forms of diabetes.
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration

This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.

This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests
* Body weight ; ≥50.0 kg, \<80.0 kg
* Body Mass Index ; ≥17.6, \<26.4 kg/m2
* Written informed consent has been obtained

Exclusion Criteria:

* Received any investigational drugs within 120 days before the screening assessment
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment
* Received medication within 7 days before hospital admission
* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission
* History of drug allergies
* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases
* Previous treatment with ASP1941
Clinical Trial on Palliative Cancer Patients With Constipation

It is a double-blinded, randomized, placebo-controlled trial for advanced cancer patients with constipation. 60 patients will be randomly assigned to have individualized herbal intervention (treatment group) or placebo (control group) in 1:1 ratio. For the treatment group, MaZiRenWan 10g plus HuangQi 20g are chosen as the core prescription. Furthermore, six herbal granules can be added according to the syndrome differentiated for individual participant. Placebo is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%), and caramel (0.34%) to achieve color, smell, taste, and texture comparable to the herbal granules. Patients are instructed to dissolve the granules in 150ml of hot water, twice daily for two weeks. The primary end point is the global symptom improvement. Secondary outcome measures include stool frequency, stool form, use of rescue herbal granules, constipation visual analogue scale (CVAS) (0=none to 7=most severe) and individual assessment of constipation related symptoms. For the safety profiles of herbal intervention, the important adverse events reported and clinical laboratory evaluations of liver and renal function are determined.


Eligibility Criteria:
Inclusion Criteria:

* Severity of constipation \> 3 points (an 8-point scale from 0 to 7)
* Palliative Performance Scale ≥60%
* Relatively stable liver and renal function within 3 months
* Patients who can read and speak Chinese

Exclusion Criteria:

* Inability to communicate
* Presence of a colostomy, or gastrointestinal obstruction
* Presence of loose or watery stool (Bristol stool scale 6-7) or bowel movement \> 3/day under routine laxative treatment
* History of Chinese herbal medicine allergies
* Estimated life expectancy less than 1 month
Clinical Trial for High Intensity Laser Therapy (HILT) for Elbow Epicondylosis

This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of elbow epicondylosis

The diagnosed patients with epicondylosis will be treated with HILTERAPIA HIRO 3.O for a total of four sessions during the entire duration of the treatment protocol. Parameters to be evaluated are tenderness, pain upon active resistive motion and DASH scores. After every treatment session of HILTERAPIA HIRO 3.O, these said parameters will be recorded initially on the first treatment, one week after the initial treatment, two weeks after the initial treatment and four weeks after the initial treatment. Patient is advised to follow-up on the 6th and 12 month post initial HILTERAPIA HIRO 3.O treatment for the reevaluation of the parameters. Tenderness is described as pain upon palpation and is further categorized into, 0= no tenderness, 1 = mild tenderness, 2 = tenderness evident on facial expression and 3 = patient screams upon palpation. Pain is also noted upon active resistive motion of extension/flexion, supination/pronation. Classification includes; 0 = no pain and 1 = mild pain with full power, 2 = severe pain with full power, and 3 = muscle weakness with pain. And for functional scoring will be using the DASH which is a multidimensional disease specific, brief, self-administered measure of symptoms and functional status among subjects with upper limb disorders. The DASH consists of a 30-item questionnaire with 5 response options for each item with a scale ranging from 0, which indicates "least disability," to 100, which indicates "most disability." A change in 12.7 DASH score points is considered to represent clinically significant functional improvement.

Eligibility Criteria:
Inclusion Criteria:

* history of medial and lateral elbow pain for at least three months in duration
* local tenderness for at least three months in duration
* pain on the epicondyle upon active resistive flexion (medial) and extension (lateral) of the wrist

Exclusion Criteria:

* previous elbow conservative managements such as physical therapy and elbow injection-based therapies
* previous surgical management of the elbow
Prediction of Chemotherapy Toxicity and Survival in Elderly Cancer Patients by CARG Score

Prediction of chemotherapy toxicity and survival in elderly (aged ≥65 years old) patients with advanced solid tumors receiving systemic chemotherapy by using CARG risk score.

Elderly patients (age ≥65 years) with cancer represent a growing proportion of patients in oncology clinical practice, primarily due to increasing life-spans as well as medical progress contributing to decreased morbidity and mortality from other causes.

Treatment decision-making for elderly patients with advanced cancer is often more complex than decision-making in younger cancer patients. The elderly population is heterogeneous in terms of their overall health status beyond their cancer diagnosis.

The risk of severe chemotherapy toxicity is one of the most important factors oncologists consider when recommending a treatment plan, and in elderly patients with advanced cancers, 25% to 60% of patients are treated with a planned dose reduction for their first chemotherapy cycle. These dose reductions are usually made on the basis of chronologic age and ECOG performance status, variables well known to be poor predictors of chemotherapy toxicity risk and tolerability of treatment.

Clinical prediction tools provide physicians with more accurate means for identifying patients who are at low or high risk of adverse outcomes.

The cancer Aging Research Group (CARG) risk score, developed by Hurria and colleagues, is a validated geriatric assessment tool that predicts for significant chemotherapy-related toxicities (grades 3-5) in older North American adults aged ≥65 years starting on chemotherapy.

The CARG score uses 5 key geriatric assessment (GA) domains, selected laboratory test values, age, tumor type, and treatment intensity to categorize patients into 3 risk groups for severe chemotherapy toxicity (grade 3-5): low risk (score 0-5; 30% grade 3-5 toxicity), medium risk (score 6-9; 52%), or high risk (score ≥10; 83%).

The CARG risk score has been validated in other countries and in specific tumour sites to varying degrees. It is included in ASCO Guideline and NCCN guidelines for Geriatric Oncology to predict severe chemotherapy-related toxicity. However its applicability in Egyptian patients is unknown as geriatric assessment is not routinely used for elderly patients.

The investigators may provide an evidence for validating the CARG risk score in Elderly patients with advanced solid tumors receiving systemic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥65 years.
* Sex: male, female.
* ECOG performance status 0,1,2
* Type of malignancy: solid tumor malignancies planned for systemic chemotherapy alone.
* Stage: Advanced stage (metastatic first line, recurrent, unresectable locally advanced).
* Type of Systemic therapy: chemotherapy alone not combined with immunotherapy or radiotherapy.
* Able to comprehend and complete questionnaire.

Exclusion Criteria:

* Receiving concurrent radiotherapy or immunotherapy.
* ECOG performance status \>2.
Capecitabine Metronomic Chemotherapy Plus Aromatase Inhibitor for Postmenopausal Hormone Receptor Positive Breast Cancer

The present study is to determine the adverse effects and clinical efficacy of AI combined with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with Estrogen receptor and/or Progestrogen receptor positive.

Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used as first-line and second-line rescue therapy for advanced breast cancer ,third-generation aromatase inhibitors (AI) is the preferred adjuvant endocrine therapy for Postmenopausal hormone-sensitive breast cancer. Study showed that AI combined with metronomic chemotherapy could improve the objective response and clinical benefit in neoadjuvant therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Hormone receptor positive;
2. previously untreated patients who do not receive hormonal therapy, or initial endocrine treatment failure or first -line endocrine treatment of relapse and metastasis failure;
3. patients who do not receive hormonal therapy must be histologically confirmed invasive ductal carcinoma, can be surgery, but must be satisfied one of the following: (1) elderly (≥70 years), or with severe heart or other systemic complications, belonging to high risk of general anesthesia, (2) have will of conserving the breast,but larger tumors (≥3cm) not suitable for breast-conserving surgery.
4. patients with metastatic breast cancer must have evaluable lesions
5. normal laboratory values:
6. informed consent (ethical approval document No. :1112105-1);
7. life expectancy of at least 3 months;
8. Postmenopausal or premenopausal with bilateral oophorectomy.

Exclusion Criteria:

1. have had radiotherapy or other local treatment for measurable lesions before the start of study received within 3 months
2. organ transplant (except for autologous or allogeneic bone marrow transplantation);
3. have evidences of central nerve system metastases or have a history of mental illness that uncontrol;
4. unable to swallow tablets, or malabsorption patients, or patients with poor upper gastrointestinal integrity;
5. unwilling or unable to comply with study protocol or unable to meet the follow up;
6. patients who researchers considered were not suitable to participate.
Effectiveness and Safety of tDCS for Pain

The purpose of this study is to verify the effectiveness and safety of transcranial direct current stimulation in patients with central post-stroke pain.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 to 90 years old
2. Those who have been diagnosed with first-time stroke through doctors' clinical observation and brain imaging diagnosis
3. A person whose stroke lesions are cortex or subcortex
4. A person who satisfies 'Mandatory criteria'
5. Those with cognitive ability to understand and follow the researcher's instructions
6. Those who voluntarily agree to participate in this clinical trial and signed the agreement

Exclusion Criteria:

1. Those who have a fracture or have undergone orthopedic surgery
2. In case of accompanying serious neurological diseases
3. In case of major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia
4. Those with complex part pain syndrome by Budapest Criteria
5. If there is a cause of other pain in the relevant area, such as peripheral nerve damage
6. Persons included in the exclusion of transcranial direct current stimulation
7. If the researcher is judged to be judged that the participation in this study is not appropriate