cyrilzakka/clinical-trials huggingface dataset:
Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia

ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior plane block, for preventing postoperative pain after breast surgery for cancer. This block will be compared with the well-established paravertebral block.

Paravertebral block (PVB) can be considered as a well-established option to provide anesthesia and postoperative analgesia during breast surgery. For patients receiving a PVB alone or in combination with general anesthesia significant lower resting, evoked and worst pain scores compared with other analgesic treatment strategies indicating that a PVB provides improved postoperative pain control in patients undergoing breast surgery. Furthermore, there might be a reduced need for postoperative opioid requirements and consecutively a decrease in opioid-induced adverse effects in patients receiving a PVB. Anyways there are always fear of pleural injury and pneumothorax in addition to epidural and intrathecal spread of the block. A novel newly introduced field block has been described recently to block the hemithorax under ultrasound guidance that is the Serratus Anterior Muscle Plane SAM block. Still this technique to the investigators knowledge is not tried in randomized clinical studies. The aim of this study is to find out that this new technique is comparable to PVB in patients undergoing breast surgeries with or without axillary node dissection.

Eligibility Criteria:
Inclusion Criteria:

* unilateral mastectomy with or without axillary lymph node dissection.
* American Society of Anesthesia (ASA) I\&II

Exclusion Criteria:

* morbid obesity (body mass index \> 40 kg/m2);
* renal insufficiency (creatinine \> 1.5 mg/dL),
* current chronic analgesic therapy (daily use \> 4 weeks),
* a history of opioid dependence, pregnancy,
* inability to communicate with the investigators or hospital staff,
* American Society of Anesthesia (ASA) III-IV
Anesthesia in Flexible Bronchoscopy for Lung Cancer Diagnostic

The objective of the study was to establish which anesthetic procedure used during flexible bronchoscopy has the lowest index of complications.

This prospective randomized study analyzed 80 patients that underwent flexible bronchoscopy. Patients were randomly assigned to four groups of 20 patients each according to the anesthetic combination used: 200 mg topical lidocaine (LID group); 200 mg topical lidocaine and 2 mg/kg propofol (PPF group); 200 mg topical lidocaine and 20 mcg/kg alfentanil (ALF group); or 200 mg topical lidocaine and 0.05 mg/kg midazolam (MID group). Scores were assigned to patients according to the different variables observed during the endoscopic procedure; the lower the score, the lower the complication index.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in this study were referred to FBC for the investigation of bronchial carcinoma (diagnostic procedure).
* Patients included in the study were classified as ASA I, II and II according to the anesthetic risk classification of the American Society of Anesthesiologists (ASA).

Exclusion Criteria:

* ASA IV classification of anesthesiology risk
* procedure that lasted longer than 15 minutes
* indication of therapeutic bronchoscopy
* cardiac arrhythmia and / or hypoxemia detected at admission.
First-line Nab-paclitaxel Plus Cisplatin Plus Carilizumab in mTNBC Patients

To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Female patients aged 18-70 years who had
2. Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
3. Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
4. Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
5. At least one measurable lesion according to RECIST 1.1,
6. ECOG performance status ≤ 1
7. Life expectancy of more than 12 weeks
8. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Patient of childbearing potential but unwilling to receive contraception.
2. Radiation therapy of axial bone within 4 weeks before enrollment.
3. Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
4. Patients have active autoimmune diseases.
5. Patients who need systemic corticosteroids (\> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
6. Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
7. Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
8. Uncontrolled infection.
Trial of an Educational Intervention to Promote Spectacle Use Among Secondary School Children in Islamabad, Pakistan

This study is planned to test an educational intervention promoting the use of spectacles among secondary school children. It is based on the hypothesis that educating teachers, parents and children about the importance of wearing spectacles has the potential to increase spectacle wear among children.Reasons for non-compliance towards spectacle use will be explored and educational intervention will be planned considering these reasons. Educational intervention will increase awareness about the importance of spectacles use and reduce the barriers towards spectacle use.Reducing barriers will increase compliance towards spectacles use which will ultimately prevent the avoidable visual impairment.

Aim of this research is to improve school performance and quality of life of children with refractive errors. Planned research will be carried out in eight (4 girls and 4 boys) Public Sector Secondary Schools of Islamabad and vision of students will be tested with standard snellen chart to recruit 120 boys and 120 girls with refractive errors. Students having vision ≤ 6/12 will receive auto refraction and prescription of spectacles will be given after subjective refraction. primary outcome of purchase of glasses will be asessed at three months after prescribing. Follow up after six months of prescribing spectacles will find out compliance towards spectacles. Non-compliant students will be given a questionnaire to provide the reasons for non-compliance towards spectacles. Focus Group Discussions (FGDs) will be conducted with non-compliant students, their teachers and parents to explore reasons of non compliance.

On the basis of information obtained from FGDs an educational intervention will be planned for students, their parents and teahers to explain importance of spectacles. Through stratified randomization schools will be assigned to intervention and control groups. Four schools including two girls and two boys schools will be assigned to intervention group and four schools (two girls and two boys) will be assigned to control group. Educational intervention will be given to intervention group. Six months after the intervention compliance to spectacle wear will be assessed than pre and post intervention compliance in intervention group and between two groups will be compared to assess effectiveness of intervention.

Eligibility Criteria:
Inclusion Criteria:-

1- Children from 6th to 9th grade (approximate age, 11-16 years) of secondary schools in Islamabad.

Exclusion Criteria:

1. Children from 10th grade which is the final grade of secondary schools.
2. Children with eye disorders other than refractive error.
Manual Ankle Therapy on Fear of Falls, Range of Motion, and Functionality and Stability in Geriatric Patients

The range of movement of the ankle decreases with age and the plantar arch decreases, adopting a more pronated position of the foot.

The main objective is to analyze the effectiveness of manual therapy using ankle joint techniques in geriatric patients.

Randomized, double-blind clinical trial with follow-up period. Subjects will be assigned to control and experimental groups using a data analysis tool (Excel).

The dependent variable will be the fear of falls. The secondary variables will be the range of movement in dorsiflexion of the ankle, and the functionality and stability of the lower limbs.

Three evaluations will be carried out. A baseline measurement before the start of the study (T0), after the intervention (T1) and after a 3-week follow-up period (T2).

A manual therapy protocol will be carried out, lasting 3 weeks with 1 weekly session. Each session will last 10 minutes. The patients included in the experimental group will undergo the following manual therapy techniques: talus dorsal sliding technique and joint technique in "8" on the Lisfranc and Chopart joints. The patients included in the control group underwent the same techniques as those indicated for the experimental group, but without sliding or placing joint tension. The periodicity and times of administration will be the same


Eligibility Criteria:
Inclusion Criteria:

* Subjects older than 65 years
* Subjects of both sexes
* With impaired balance and gait
* With joint limitation of ankle dorsiflexion
* With established functionality or stability deficits (for example, who need third parties or technical aids to walk (crutches))

Exclusion Criteria:

* People with cognitive impairment that prevents their collaboration in the intervention and the different evaluations
* People with inability to stand
* People who have not given their written consent.
Tracheal Mechanics During Bronchoscopy

The main purpose of this study is use a new type of measurement to help decide what kind of therapy would help people with a collapsing windpipe or tracheomalacia.

This study is to obtain new information about the pressures required to collapse the trachea in patients with and without obstructive pulmonary disease and to describe the relationship between pressures and airflow obstruction. This information will provide normative data not currently available and would establish whether tracheal collapse is due to tracheomalacia. The data may lead to better ways of predicting if a patient would benefit from procedures to prevent tracheal collapse.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of tracheal collapse undergoing bronchoscopy
* Healthy control subject undergoing bronchoscopy for another purpose.

Exclusion Criteria:

* Esophageal pathology
* Tracheostomy
* inability to follow commands
Creatine Supplementation At Simulated Altitude

Creatine supplementation has been shown to increase exercise performance at sea level. The goal of this study is to determine the effects of creatine supplementation on exercise performance at simulated altitude.

Military personnel often encounter harsh environments such as high altitudes and hypoxic conditions, leading to significant constraints on their exercise capacity and performance. At sea-level creatine supplementation increases exercise performance; however no experimental studies have examined the effect of creatine supplementation at simulated altitude. The overall objective of this study is to investigate the effects of creatine supplementation on exercise performance, via a repeated sprints test (Wingate Test) after a 2-day supplementation period, compared to a placebo group.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years old
* BMI 18.5 to 40 kg/m2
* Habitually active (\>150 minutes per week of moderate-vigorous physical activity)

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Recent use of creatine supplementation
* Supplemental allergies
Paclitaxel and Cisplatin as First-Line Treatment for Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving paclitaxel together with cisplatin as first-line therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV ovarian epithelial cancer.

OBJECTIVES:

* To investigate the efficacy and safety of paclitaxel and cisplatin as first-line chemotherapy in patients with stage IC-IV ovarian epithelial cancer.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV and cisplatin IV once every 2 weeks. Treatment repeats every 2 weeks for 9 courses in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed epithelial adenocarcinoma of the ovary

  * Stage IC-IV disease
* No known or clinical evidence of brain metastasis

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* Hemoglobin must be ≥ 90 g/L
* ANC ≥ 2 x 10\^9/L
* Platelet count ≥ 100 x10\^9/L
* Serum creatinine ≤ 115 μmol/L
* Total bilirubin ≤ 25 μmol/L
* Not pregnant or nursing
* No other serious disease which could affect protocol compliance and results
* No other prior malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix or squamous carcinoma of the skin
* No peripheral neuropathy ≥ CTCAE version 3.0 grade 2
* No known hypersensitivity to any of the study drugs or their excipients
* No drug addiction or alcoholism
* No disorder which leads to the condition that contraindicates the use of the investigational drugs, or that may affect the patient's compliance with the study requirements

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy or radiotherapy for ovarian cancer
Study Of Generalized Anxiety Disorder

This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients

This study was a multi-center, randomized, placebo-controlled, double-blinded (placebo run-in will be single-blinded), group comparison study.

Paroxetine 20mg/day (achieved via the starting dose of 10 mg/day for the first week) once daily, or placebo was orally administered once daily for 8 weeks (fixed dose was adopted in the Treatment phase) in patients with GAD.

For subjects who were classed as non-responders at Week 8, paroxetine at 30 to 40mg/day (once daily) or placebo (once daily) was orally administered with flexible titration regimen for 4 weeks (fixed dose was adopted in the Treatment phase). The subjects underwent a taper phase in case they received Paroxetine 40mg/day, paroxetine 30mg/day or placebo at treatment completion or study withdrawal. A follow-up examination was conducted after 1 to 5 weeks from the last dose of the investigational product.

The overall study duration requiring subject participation was 10 to 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Generalized Anxiety Disorder (GAD) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
* Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written informed consent.

Exclusion Criteria:

* Have the following conditions currently or diagnosed in the past 24 weeks:

Major Depressive Episode, Panic Disorder Without Agoraphobia, Panic Disorder With Agoraphobia, Social phobia/social anxiety disorder (SAD), Agoraphobia Without History of Panic Disorder, Posttraumatic Stress Disorder, Obsessive Compulsive Disorder, Anorexia Nervosa, Bulimia Nervosa, Dysthymic disorder

* Current or history of schizophrenia, bipolar disorder or cyclothymic disorder.
* Psychotherapy or cognitive behavioral therapy other than supportive psychotherapy.
* Current or history of substance abuse (alcohol or drugs) or substance in past 24 weeks.
* Taken St. John's Wort in past 4 weeks.
* Had electroconvulsive therapy (ECT) in past 12 weeks.
* Had psychotherapy or cognitive behavioral therapy other than supportive psychotherapy within 24 weeks.
* Women who are pregnant or lactating, who may be pregnant, or who plan for pregnancy by 30 days after the completion of final dose.
* Pose a suicidal threat or have attempted suicide in past 24 weeks.
* History of convulsive disorder (epilepsy, etc.).
* Significant unstable medical illness.
* Current or history of glaucoma.
* History or complication of cancer or malignant tumor.
* History of hypersensitivity to paroxetine.
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.


Eligibility Criteria:
Inclusion Criteria -

1. Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
2. ECOG Performance Status of 0-2.
3. Life expectancy of \>12 weeks.
4. No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
5. No active serious infection or other comorbid illness which would impair ability to participate in the trial.
6. Stable or decreasing dose of steroids for ≥ 7 days.
7. Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
8. Patients must have adequate organ function.

Exclusion Criteria -

1. Pregnant or breast-feeding
2. Prior allergic reaction to INIPARIB
3. Prior allergic reaction to irinotecan.
4. Evidence of hemorrhage or impending herniation on baseline brain imaging
5. Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
6. Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
7. Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
8. Contraindication to gadolinium-enhanced MRI imaging.
9. Inability to comply with study and/or follow-up procedures.
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.

The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma


Eligibility Criteria:
Inclusion Criteria:

* aged from 18 to 75 years
* having histologically confirmed NHL expressing CD20 antigen
* having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months
* signed an informed consent form which was approved by the institutional review board of the respective medical center

Exclusion Criteria:

* single measurable lesion ≥7 cm in diameter
* with serious hematologic dysfunction (white blood cell count of \<3.0×103/μL; absolute neutrophil count of \<1.5×103/ μL; platelet count of \< 75×103/μL; hemoglobin level of \< 8.0 g/dL; serum immunoglobulin G(IgG) level of \<600 mg/dL);, hepatic dysfunction (total bilirubin level of \> 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of \>2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of \> 1.5×ULN )
* having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
* had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
* had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
* with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
* having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
* with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
* with a history of allergic reaction or protein product allergy including murine proteins
* pregnant or lactating or not accepted birth control methods including male patients
Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (International Classification of Headache Disorders 3rd edition)
* Migraine onset before age 50 years
* By history, the participant's migraines typically last between 4 and 72 hours if untreated or treated unsuccessfully and migraine episodes are separated by at least 48 hours of headache pain freedom
* History of 2 to 8 migraine attacks per month with moderate to severe headache in each of the 3 months prior to the Screening Visit

Exclusion Criteria:

* Difficulty distinguishing migraine headache from tension-type or other headaches
* Participants who overuse medication for migraine defined as use of opioids or barbiturates \> 2 days/month, triptans or ergots ≥ 10 days/month, or simple analgesics (eg, aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen) ≥ 15 days/month in the 3 months prior to Visit 1 per investigator's judgment
* Has a history of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD-3
* A current diagnosis of chronic migraine as defined by ICHD-3 or a history of 15 or more headache days per month on average in the 6 months prior to Visit 1 in the investigator's judgment. A headache day is defined as a day in which there was any occurrence of a headache of a minimum duration of 2 hours or a headache of any duration for which acute medication was taken
* Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3
* Required hospital treatment of a migraine attack 3 or more times in the 6 months prior to Visit 1
* History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
* History of any prior gastrointestinal conditions (eg, diarrhea syndromes, inflammatory bowel disease) that, per investigator judgment, may affect the absorption or metabolism of the study intervention; participants with prior gastric bariatric interventions (eg, Lap Band) which have been reversed are not excluded
Calcium Phosphate and Incretins

The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins.


Eligibility Criteria:
Inclusion Criteria:

* healthy men

Exclusion Criteria:

* intake of dietary supplements and chronic diseases