cyrilzakka/clinical-trials huggingface dataset:
The Role of the Cervical Spine in Carpal Tunnel Syndrome

This randomized clinical trial will investigate changes in hand function, active cervical range of motion and pinch grip force after the application of physical therapy in women with carpal tunnel syndrome (CTS). The purpose of this study is to compare changes in function, cervical range of motion and pinch grip force induced after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or after endoscopic surgery in women with CTS at medium and long-term follow-up. The hypothesis is that manual therapy is more effective for increasing cervical range of motion and pinch grip force, but similarly effective for improving function, than surgical treatment in women with CTS.

There is some evidence suggesting that CTS is associated with restricted cervical range of motion and deficits in pinch grip force. In fact, restricted cervical range of motion and deficits in pinch grip force seems to be independent of electro-diagnostic findings. These findings would be associated with the proposed "double crush syndrome" theory. However no longitudinal studies have been conducted. Further it has been demonstrated that hand function is associated to deficits in these outcomes. Since previous studies support the use of physical therapy and surgical interventions for the management of function in these patients, the aim of this study is to conduct a randomized clinical trial to determine if changes in hand function are related to changes in active cervical range of motion and pinch grip force after the application of a physical therapy program including manual therapies targeted to those areas related to the median nerve or endoscopic surgery in women with CTS.

Eligibility Criteria:
Inclusion Criteria:

* Pain and paresthesia in the median nerve distribution
* Positive Tinel sign,
* Positive Phalen sign,
* Symptoms had to have persisted for at least 6 months
* Deficits of sensory and motor median nerve conduction according to guidelines of the American Association of Electrodiagnosis, American Academy of Neurology, and the American Physical Medicine and Rehabilitation Academy

Exclusion Criteria:

* Any sensory/motor deficit related to the ulnar or radial nerve;
* Older than 65 years of age;
* Previous surgical intervention, steroid injections or physical therapy intervention
* Multiple diagnoses of the upper extremity (eg, cervical radiculopathy);
* History of neck, shoulder, or upper limb trauma (whiplash);
* History of any systemic disease causing CTS (eg, diabetes mellitus or thyroid disease);
* History of other systemic conditions (eg, rheumatoid arthritis, fibromyalgia);
* Pregnancy
Bronchial Inflammation in Patients With Bronchiolithis Obliterans

The investigators plan to study the variability of lung function parameters and bronchial inflammatory markers in 20 patients with bronchiolitis obliterans at the age of 6 to 25 years compared with an age- and sex-matched control group. The investigators will perform a pulmonary function test (body plethysmography with TLCO), and measure the fraction of exhaled nitric oxide (eNO). Further a blood sample is drawn to determine the systemic inflammation. Finally induced sputum is collected and a cell count is performed, and cells and supernatants are analyzed for inflammatory markers. This investigation will be repeated after 4-6 weeks. The aim of this study is to define baseline values and the variability of possible outcome parameters for future interventional studies.

The purpose of this study is to characterize the variability of lung function values and bronchial inflammation of 20 Patients with Bronchiolitis obliterans aged between 6 up to 25 years. The patients' data will be compared with the results of a reference group with similar age conditions to determine possible outcome-parameters for following interventional studies.

The sputum samples will be processed and quantitatively analyzed to get a profile of the cytological composition.

(Sputum and serum samples are analyzed by quantitative real-time polymerase chain reaction (PCR) (qRT-PCR) and by cytometric bead assay (CBA).)

Methods and Work Programme:

This study consists of two study visits (V1 and V2)

V1:

* Measurement of nitric oxide in expired air (eNO)
* Lung function testing with spirometry and body plethysmography
* Bronchodilation
* Lung function testing with spirometry and body plethysmography
* Blood test: blood count, CRP, RAST, serum inflammatory mediators, (genetic markers of the non-specific pulmonary defense system)
* Induced sputum for inflammatory mediators and microbiological investigations

V2:

* Measurement of nitric oxide in expired air (eNO)
* Lung function testing with spirometry and body plethysmography
* Bronchodilation
* Lung function testing with spirometry and body plethysmography
* Induced sputum for inflammatory mediators and microbiological investigations

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 6 and 25 years of age
* Known Bronchiolitis obliterans

  * no Bronchiolitis obliterans(depending on the study group)
* Ability to perform lung function tests and inhalation

Exclusion Criteria:

* Acute illness with systemic or bronchial inflammation
* every chronic condition or infection (eg HIV, tuberculosis, malignancy)
* pregnancy
* known alcohol and/ or drug abuse
* Inability to understand the extent and scope of the study
* Participation in another study
A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer

The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.


Eligibility Criteria:
Inclusion Criteria

* Females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
* Histologically or cytologically confirmed with breast cancer
* Score 3+ by immunohistochemistry (IHC) or HER2 positive by Fluorescence in Situ Hybridization (FISH) method
* Subjects who meet any of the following criteria:

  * Evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
  * Evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
  * Experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
* Adequate organ function
* Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) is 0 or 1
* Subjects who have submitted written informed consent for study entry

Exclusion Criteria

* Subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
* Subjects with severe active infection requiring active treatment
* Subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
* Hypersensitivity to trastuzumab, halicondrin B or halicondrin B chemical derivatives
* Known positive for human immunodeficiency virus (HIV) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV) by serum test.
* Subjects who are pregnant (positive B-hCG test) or breastfeeding
* Subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors

An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.


Eligibility Criteria:
Inclusion Criteria.

1. Provision of full informed consent prior to any study-specific procedures.
2. Patients must be ≥18 years of age, at the time of signing informed consent.
3. Dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. Tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer.
4. Dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), with one of the documented deleterious mutations of specified HRR genes and whose disease has progressed following at least one standard therapy.
5. Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment at follow up-visits.
6. ECOG performance status 0 to 2.
7. Use of contraception measures

Exclusion Criteria:

1. Patients with HER2 positive breast cancer
2. Patients receiving anticancer therapy
3. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
4. Prior treatment with a PARP inhibitor
5. Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
6. Patient with symptomatic uncontrolled brain metastasis.
7. Pregnancy and lactation
8. Patients with uncontrolled disease
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®

To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.

This study will be performed to evaluate if the new generic GPO ritonavir product is bio-equivalent to Norvir and to compare the short-term tolerability and safety profiles.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Healthy male or female 18-45 years old
* Documented negative test for HIV-1 infection \< 1 wk prior to start of study and with no risk of
* HIV exposure in the last 6 months
* For female subjects: documented negative pregnancy test \<3 wk prior to start of study, not breastfeeding
* BMI 18-25
* Normal physical examination
* Normal CBC, BUN, Cr, AST, ALT, Total bilirubin, no evidence of active or chronic HBV or HCV Infection

Exclusion Criteria:

* History of sensitivity/idiosyncrasy to the drug or chemically related compounds or excipients, which may be employed in the study.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the study and the procedures required.
* Participation in a drug study within 60 days prior to the first dose.
* Febrile illness within 3 days before the first dose.
* Use of concomitant medication
* Smoke cigarettes not more than 10 cigarettes a day.
* Drink alcohol not more than 2 units a day
* Discontinue smoking and alcohol for at least 1 month before enrollment.
* Take other medication regularly
* Involvement in any drug addiction
* Heart disease, hypertension, liver disease, kidney disease, GI disease, allergic disease or other diseases which may interfere with the PK of study drugs
A Study of Subcutaneous (sc) Mircera in Dialysis Patients With Chronic Renal Anemia.

This study will determine the appropriate dose and frequency of administration of sc Mircera maintenance therapy in dialysis patients with chronic renal anemia who were previously receiving sc epoetin alfa or beta. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* on dialysis (hemodialysis or peritoneal dialysis) therapy for at least 3 months;
* receiving sc epoetin alfa or beta for at least 3 months prior to the run-in period.

Exclusion Criteria:

* women who are pregnant, breastfeeding or using unreliable birth control methods;
* use of any investigational drug within 30 days preceding the run-in phase, or during the run-in or study treatment period.
Effect of Sarcopenia on the Occurrence of Toxicity Related to Anti-cancer Treatments

The goal of this clinical trial is to learn about the effect of sarcopenic status on the occurrence of treatment-related toxicity during the first course of anti-cancer treatment in several types of cancers.

The main question it aims to answer is :

Is sarcopenia a predictive marker for the occurrence of toxicity in the initial phase of cancer treatment?

The evaluation will focus on the body composition of the participants, assessed by impedancemetry, and on their muscular performance by standardized physical tests.

The present study is single-center within the Centre Hospitalier Metropole Savoie, interventional and prospective, and will be carried out in patients suffering from cancer and having received an indication for systemic oncological treatment, in first line,

The inclusion visit (V1) will take place during the first chemotherapy session and will include study-specific measurements for the assessment of sarcopenia (impedancemetry, grip strength and chair rise test) as well as the distribution of actimeters to patients. The duration of these examinations carried out in addition to clinical practice is estimated at 15 minutes and does not involve any particular risks for patients.

Data collection 1 (R1) will be carried out during the second course of chemotherapy, data collection 2 (R2) will be carried out 6 months from the start of treatment, and data collection 3 (R3) at 12 months from the start of treatment. inclusion, based on standardized extraction of the medical file.

An exploratory study will be offered to patients treated in the context of adjuvant or neoadjuvant breast cancer and treated by the AC/PACLITAXEL protocol which will involve a second optional visit (optional V1.1) during the first injection of PACLITAXEL . An optional data collection (R1.1) will take place during the first cycle to collect actimetry data. And an optional data collection (R1.2) will take place 2 weeks after the theoretical end of PACLITAXEL in order to collect on file the grades of neuropathies and toxicities over the interval.

The visits will be carried out as part of the usual patient care.

Apart from the measurement of impedancemetry, grip strength, the chair rise test and actimetry, no other clinical, paraclinical intervention or biological analysis will be induced by the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patient with a diagnosis of a histologically proven solid malignant tumor with an indication for systemic treatment during initial treatment.
* CT/PET performed within 45 days before initiation of systemic treatment.
* Patient able to sign informed consent for participation in the study
* Patient affiliated to a social security system

Exclusion Criteria:

* History of cancer in the five years preceding inclusion other than localized skin or cervical cancers.
* Patient with cancer not requiring systemic treatment.
* Pregnant women.
* Patient with a pace maker or defibrillator
* Patient deprived of liberty or benefiting from a legal protection measure
A Retrospective Cohort Study of 15 Cases of Pelvic Fractures Complicated by Morel-Lavallee Lesion

Some related factors of pelvic fracture and Morel-Lavallee injury (MLL) are preliminarily discussed, which provides some preliminary references for early clinical detection and research of such injuries.

Inclusion criteria: (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.

Exclusion criteria: (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.

Eligibility Criteria:
Inclusion Criteria:

* (1) The clinical symptoms are consistent with the diagnosis of pelvic fracture, and the diagnosis is confirmed by imaging, including emergency or sub-emergency CT data within 72 hours after injury. (2) The symptoms of the diagnosis of MLL were pain and swelling at the site of occurrence, a sense of soft tissue fluctuation found on physical examination, and a complete process of puncture drainage + negative pressure suction therapy. (3) The patients and their families have given informed consent to this study and signed the informed consent form, which meets the ethical requirements.

Exclusion Criteria:

* (1) Incomplete imaging data, especially the lack of emergency or sub-emergency CT data within 72 hours after injury. (2) Cases of other severe lower limb fractures such as femur and trochanter, and lower limb fractures combined with MLL injury have been reported in the literature.
Bronchial Allergen Provocation Tests in Asthmatics in Guangzhou

The purpose of this study is to establish the methodology of bronchial provocation tests with house dust mites in China, and to evaluate its safety and effects on upper and lower airways inflammation.

After screening,each participant undergo baseline lung function test,airway inflammation evaluation (blood and sputum eosinophils count,interleukin-13 (IL-13),FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

On the second day,the participant undergo bronchial house dust mites challenge tests.

On the third day,the participant undergo the lung function test,airway inflammation evaluation (blood and sputum eosinophils count,IL-13,FeNO)and airway responsiveness tests(methacholine bronchial provocation,nasal histamine provocation).

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma;
* Sensitive to house dust mite;
* Stable for more than 4 weeks with FEV1≥70%pred

Exclusion Criteria:

* exacerbation within 3 months;
* upper airway infections within 6 weeks;
* concomitant of hypertension or heart diseases;
* pregnancy
Enhanced Cue Exposure Therapy for Negative Emotional Eating

The current study aims to evaluate the efficacy of Enhanced Cue Exposure Therapy (E-CET) in reducing negative emotional eating (NEE), compared to an active control intervention, behavioral lifestyle intervention (BLI), in a parallel-group, participant-blinded, randomized controlled trial. The secondary aim is to evaluate whether changes in conditioned stimulus-unconditioned stimulus (CS-US) expectancies mediate the changes in NEE.

Participants will be randomly assigned to either the experimental treatment or control BLI group. Participants in the experimental group will receive 6 weeks of E-CET treatment and those in the control group will receive 6 weeks of behavioral counselling integrating behavioral strategies for making changes related to diet and exercise. Outcomes will be assessed at baseline, posttreatment, and 3- and 12-month follow-ups.

Research question 1:

Is E-CET an efficacious intervention for reducing NEE?

Hypothesis 1:

E-CET will lead to greater reductions in NEE at posttreatment and follow-up compared to BLI.

Research question 2:

Does E-CET work via the violation of the CS-US expectancies?

Hypothesis 2:

Changes in the believability of CS-US expectancies will mediate the treatment effects of E-CET on NEE.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 or over
* a score \>3.25 on the emotional eating subscale of the Dutch Eating Behavioural Questionnaire lasting for three months or longer
* confirmed to have, on average, two or more NEE episodes per week using ecological momentary assessments (EMAs)

Exclusion Criteria:

* active suicidal intent or plan
* psychiatric illnesses except mood disorders, anxiety disorders, and eating disorders because mood and anxiety disorders and symptoms are common in those with NEE
* currently receiving psychotherapy, or adjusting to changing psychiatric medication
* substance abuse
* any conditions or circumstances that prevent the participant from receiving all treatment sessions
Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS).

Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

A Double-Blind Phase 3 Extension Trial Assessing the Long Term Safety and Efficacy of Glepaglutide in Patients with Short Bowel Syndrome (SBS)

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activity
* Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

Exclusion Criteria:

* Withdrawal of consent from the lead-in trial
* Any condition or disease or circumstance that in the Investigator's opinion would put the patient at any undue risk, prevent completion of the trial, or interfere with the analysis of the trial results
* Use of GLP-1, GLP-2, human growth hormone, somatostatin, or analogs thereof, within 3 months prior to Screening
* Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant or are not using highly effective contraceptive methods
Evaluate SLN360 in Participants With Elevated Lipoprotein(a) at High Risk of Atherosclerotic Cardiovascular Disease Events

Phase 2 study to evaluate the efficacy, safety and tolerability of SLN360 administered subcutaneously (SC) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events


Eligibility Criteria:
Inclusion Criteria:

* Lipoprotein(a) at screening equal to or greater than 125 nmol/L
* At high risk of ASCVD events
* A body mass index at screening in the range of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Renal dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 at screening
* History or clinical evidence of hepatic dysfunction
* Malignancy within the 5 years before screening
* Fasting triglycerides \>400 mg/dL (4.5 mmol/L) at screening
* Currently receiving or \<12 weeks at Day 1 since receiving \>200 mg/day niacin or niacin derivative drugs
* Treatment with lipid/lipoprotein apheresis within the 12 weeks before screening
* Any previous use of approved or experimental small interfering RNA (siRNA) therapy (e.g. inclisiran). NB: use of messenger RNA (mRNA) based vaccines for infectious diseases is permitted
The Effect of Lower Back Massage on Perceived Labor Pain

The aim of the study was to assesment the change in pain scores with lower back massage, a non-pharmacological method, on perceived labor pain in the early active phase of the first stage of labor.


Eligibility Criteria:
Inclusion Criteria:

* The study group consisted of pregnant women who were at 37-40 weeks of pregnancy,
* had cervical dilatation of 4-6 cm,
* had a single, live, and vertex fetus,
* had an uncomplicated pregnancy,
* had no contraction anomalies,
* could communicate in Turkish
* planned for a vaginal delivery.

Exclusion Criteria:

* with cognitive dysfunction
* using narcotic analgesics or sedative drugs
* had any contraindications for applying a back massage