cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Lidocaine 5% Patch Versus Placebo in Patients With Osteoarthritis Pain of the Knee

Patients with unilateral or bilateral osteoarthritis (OA) of the knee participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo in the treatment of pain from OA of the knee.


Eligibility Criteria:
Key Inclusion Criteria:

1. Had unilateral or bilateral OA of the knee diagnosed according to the American College of Rheumatology (ACR) criteria based on clinical and radiographic evidence (presence of osteophytes on x-ray and written evaluation) of OA
2. Had functional capacity class rating of I, II, or III according to ACR classification
3. Had normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
4. Had discontinued use of all analgesic medications (including over-the-counter \[OTC\] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for non study pain
5. At baseline visit, patients were randomized to double-blind treatment if they had an average pain intensity rating for the index joint of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 is defined as "no pain" and 10 is defined as "pain as bad as ever imagined" as measured by Question 5 of the BPI and recorded in a diary
6. At baseline visit, patients were randomized to double-blind treatment if they had, at the baseline visit, an OA severity score for the index joint of 7 or greater on a composite scale of 0 to 24 as measured by the Index of Severity for Osteoarthrosis of the Knee

Key Exclusion Criteria:

1. Had been diagnosed with inflammatory arthritis, gout, pseudo-gout or Paget's disease that in the investigator's opinion would have interfered with the assessment of pain and other symptoms of OA
2. Had serious medical conditions requiring daily medications, such as anticonvulsants and tricyclic antidepressants, that could have confounded study results
3. Had any other clinically significant joint disease or prior joint replacement surgery at the index joint
4. Had severe renal insufficiency (creatinine clearance of \<30 mL/min)
5. Had moderate or greater hepatic impairment
6. Were taking analgesic medications, glucosamine, or chondroitin that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
7. Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period.
8. Were using lidocaine-containing product that could not be discontinued during the study
9. Had previously failed treatment with Lidoderm analgesic patch for OA
10. Had recently received either a corticosteroid injection (within 8 weeks) or hyaluronic acid (within 6 months) of study entry
11. Were unable to discontinue use of topical drugs applied to the knee
12. Were taking class I anti-arrhythmic drugs (e.g. mexiletine, tocainide)
Whole-Body Vibration Therapy in the Gait of Children With Cerebral Palsy

Observation of the effect of vibration therapy on the gait of children with cerebral palsy and the analysis of their functional evolution


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neurological developmental disorder: Cerebral Palsy. (According to DSM-V)
* Age between 2 to 11 years.
* GMFCS I and II.
* Assessed and/or intervened in or from centers, institutions, etc. who collaborate with the University of Almería or participate in them. Specifically from the "Interactúa" Child Development and Early Care Center.
* The subject, father/mother/legal guardian of each subject, prior to inclusion in the study, must have signed the informed consent for the participation of himself or his/her child in it, leaving a record that it could be abandoned if at any time they deem it appropriate and without having to justify it.

Exclusion Criteria:

* Diagnosis of Epilepsy.
* Serious blood circulation problems.
* Recent operations.
* Prosthetics.
* Start of another type of therapy different from the current one.
* Not having indication for Physiotherapy.
Vaginal Tactile Imaging in Assessment of Pelvic Floor Conditions

The clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.


Eligibility Criteria:
Inclusion Criteria:

* No prior pelvic floor surgery, and
* Normal pelvic floor conditions, or
* POP Stage I affecting one or more vaginal compartment, or
* POP Stage II affecting one or more vaginal compartment, or
* POP Stage III affecting one or more vaginal compartment, or
* POP Stage IV affecting one or more vaginal compartment.

Exclusion Criteria:

* Active skin infection or ulceration within the vagina
* Presence of a vaginal septum;
* Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder;
* Ongoing radiation therapy for pelvic cancer;
* Impacted stool;
* Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia;
* Severe hemorrhoids;
* Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician;
* Current pregnancy.
Characterization of Tuberculosis Associated Lung Fibrosis and Respiratory Impairment, and Prevention Using Doxycycline

The goal of this clinical trial is to assess the efficacy(effectiveness) of doxycycline, a potent inhibitor of matrix metalloproteinase (lung collagenase) activity in prevention of Tuberculosis associated lung fibrosis and associated lung function decline among patients with drug sensitive advanced TB. The main question\[s\] it aims to answer are:

* Does doxycycline have a significant anti-fibrosis role when given as adjuvant therapy to TB patients with advanced pulmonary TB in a double blind randomized placebo controlled trial?
* How does long term respiratory function defer between patients who received adjuvant doxycycline aimed at prevention of TB associated lung fibrosis and those who received a placebo in a double blind randomized controlled trial?

Participants will be subjected to the following:

* Experimental arm: Doxycycline 100 mg once daily for 12 weeks administered concurrently with standard of care anti-TBs.
* Comparator arm: Placebo once daily for 12 weeks administered concurrently with standard of care anti-TBs.

This will be a double-blind randomized block stratified clinical trial. Participants will be enrolled if they have advanced drug sensitive TB evidenced by infiltrates/lesions in at least 2 zones on a chest X-ray, among other inclusion criteria.

Participants will receive 100mg of doxycycline or matching placebo once a day for 12 weeks in addition to standard anti TB therapy.

Participants will undergo baseline high resolution CT scans to evaluate lung parenchyma involvement and repeat CT scans at 12 months to score TB associated fibrosis.

Lung function assessment with spirometry will be done at 6 and 12 months after enrolment to assess trends of lung function in the control and intervention study arms.

Profibrotic cytokines (TGFbeta) and Matrix metalloproteinases (1, 3 ,8,9) will be measured at baseline , 3 and 6 months after enrolment.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 - 65 years
* Index PTB episode (sputum smear positive or GeneXpert positive with rifampicin susceptibility)
* Baseline CXR showing infiltrates in at least 2 lung zones (≥30% lung involvement) meeting criteria for moderate/advanced PTB
* HIV uninfected
* Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Able to give written informed consent.

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Baseline serum creatinine or liver enzymes \>2 times above upper limit of normal
* Taking corticosteroids for ≥14 days or anti-TBs \>7days
* Prospects already enrolled in another clinical trial
* Diabetic patients (most diabetics are on metformin or have history of metformin use. Metformin is postulated to have an anti-fibrosis role)
* Patients with malignancy or on anticancer medication
* Situation where a participant is taking a drug/medication known to interact with the trial drug.
* Known allergies to doxycycline or other tetracyclines
* Known autoimmune disease
* Any factor felt to significantly increase risk of adverse event
An Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

This efficacy and safety study will evaluate LUMIGAN® RC/ LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL MALEATE-EX, 0.5%/TIMOLOL GFS 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or glaucoma that requires treatment with medication
* Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

* History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
* History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
* Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment

This study is designed to observed prospectively the efficacy and safety of 6 months and long-term treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA patients who shown insufficiency response or intolerance to DMARDs

This study will enroll 150 cases of refractory rheumatoid arthritis (RA) patients in Chinese，who are in moderate or severe disease activity and insufficiency response or intolerance to DMARDs. The participants plan to be treated with Tacrolimus alone, or along with methotrexate (MTX) if participants were tolerant to MTX. The efficacy and safety of 6 month Tacrolimus treatment in RA patients will be evaluated with DAS28 and other disease activity indices.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis;
2. Age ≥18 years;
3. Patients have a history of DMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, iguratimod, sulfasalazine) or any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），prednisone or Chinese traditional Medicine（tripterygium Glycosides，Sinomenine）for 3 months, but couldn't achieve clinical remission， or couldn't tolerate one or more DMARDs;
4. Medium or high disease activity (DAS28≥3.2);
5. Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
6. Dose of prednisone and NSAIDs remain stable for at least one month.

Exclusion Criteria:

1. Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
2. Platelet counts(PLT) \<80 x 10\^9 / L, or white blood cell (WBC) \<3 x 10\^9 / L;
3. Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
4. Renal insufficiency: serum Cr ≥ 176 umol / L;
5. Pregnant or nursing women (breastfeeding) ；
6. Patients has a history of malignancy (cure time in less than 5 years);
7. Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
8. Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.
Phototherapy in Young People With Depression

Bright light therapy is an established treatment pathway for sleep and circadian disorders and evidence suggests that it has antidepressant effects. The underlying mechanisms of these antidepressant effects are not fully understood and results from previous studies are somewhat variable. One of the important limitations of previous depression studies has been the heterogeneity of samples in which bright light therapy has been administered.

The main aim of this study is to evaluate whether the antidepressant effects of phototherapy in young persons with depression are modulated by changes in the sleep-wake cycle. We hypothesize that more pronounce initial sleep-phase delay will predict better antidepressant response to phototherapy and that the magnitude of changes in depressive symptoms across the course of the intervention will correlate with changes in the sleep-wake cycle.


Eligibility Criteria:
Inclusion Criteria:

1. Quick Inventory of Depressive Symptomatology score \> 6;
2. First episode of depression before age 25;
3. Currently engaged in, or about to start treatment for an affective disorder at a mental health clinic.

Exclusion Criteria:

1. Evidence of other sleep, neurological or primary medical conditions that could explain the current depression and/or contribute to sleep-wake dysfunction;
2. Other primary psychiatric disorders aside from anxiety disorders;
3. Significant alcohol or other substance dependence;
4. Use of medications that affect sleep, circadian rhythms, or alertness within the past month (participants stabilized on an antidepressant medication, stimulants, lithium or melatoninergic agents will not be excluded from the study);
5. Use of medications that may interact with light to produce a photoallergic reaction;
6. Eye or skin condition which may interact with bright light exposure;
7. Regular shift-work within 60-days prior to entry into the study;
8. Recent transmeridian travel.
Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU

Delirium is the most often encountered psychiatric diagnosis in the general hospital, with incidence up to 85% in the intensive care unit (ICU) setting and with significant consequences on patients' morbidity and mortality. Currently, although not FDA approved, antipsychotics are often considered the first-line pharmacological treatment. However, there can be limitations to their use, including side effects or lack of efficacy. Valproic acid (VPA) is one of the alternatives at times used in such patients which from limited case series data appears to be helpful and tolerated. VPA can provide relief from agitation that poses a threat to the safety and recovery of the patient. Moreover, mechanistically it addresses the neurochemical and cellular abnormalities inherent in delirium (it has NMDA-antagonist, anti-dopaminergic, GABAergic,anti-inflammatory, anti-apoptotic, and histone deacetylase inhibitor properties, among others). The purpose of this study is to evaluate the efficacy and tolerability of the VPA in the first known to us randomized controlled trial.

The investigators plan to investigate the efficacy and tolerability of scheduled VPA as compared to placebo with as needed basis (PRN) haloperidol (as a back-up in both arms) for treatment of hyperactive or mixed delirium. Patients will be randomized to scheduled VPA or placebo (normal saline) and both arms will have flexible PRN dosing of haloperidol. Thus, the investigators plan to learn the time to delirium resolution in patients treated with VPA versus placebo; percentage of patients responding to VPA versus placebo; tolerability of VPA versus placebo. If addition of scheduled VPA proves to shorten time to delirium resolution as compared to placebo, lead to less use of haloperidol, and/or have fewer side effects, it would provide a very important addition to our limited evidence-based repertoire of delirium treatment. Moreover, this pilot study would then pave the way for the bigger randomized control trial powered to detect its effect size.

Eligibility Criteria:
Inclusion Criteria:

* patients 18 years of age and older
* admitted to surgical ICU
* diagnosed with hyperactive or mixed delirium

Exclusion Criteria:

* hypoactive delirium
* primary team does not think patient is appropriate to participate
* no oral access (PO or NGT)
* non-English speaking
* contraindication to study medications
* pregnant women or woman of child-bearing age not on documented contraception
* QTc = or greater than 480
* hepatic dysfunction
* decreased platelets or platelet dysfunction
* bleeding disorder, current major bleeding
* history of NMS, epilepsy, or PD
* diagnosis of schizophrenia, bipolar disorder or schizoaffective disorder
* on warfarin or carbapenems
* delirium due to alcohol withdrawal
* treated with antipsychotics for more than 48 hours prior to study enrollment.
Efficiency of Muscle Energy Techniques

Purpose: The aim of this study is to investigate the efficiency of the Muscle Energy Technique in female patients with mechanical low back pain.

Methods: A total of 40 female participants aged 30-45 were randomly divided into two groups (Study Group and Control Group). Control group participants were under 10 sessions conventional physical therapy and rehabilitation (TENS, US, hot pack) and performed standard home exercises. Study Group participants were under 8 sessions muscle energy technique in addition to conventional physical therapy and standard home exercises. Pain (Visual Analog Scale-VAS), spinal mobility (Modify Schober Test-MST), flexibility (Fingertip Floor Distance-FFD, Right and Left Lateral Flexion Floor Distance-LFFD), quality of life (Nottingham Health Profile-NHP), disability (Oswestry Disability Index-ODI), kinesiofobia (Tampa Kinesiofobia Scale-TKS) and depressive symptoms (Beck Depression Inventory-BDI) were measured at baseline, after the treatment and 3th months.

There are many epidemiological and statistical studies showing the high incidence and prevalence of low back pain, which is a common problem all over the world (Manga et al 1993). Mechanical causes constitute 90% of the factors that cause low back pain (Diamond and Borenstein 2006).

Mechanical Low Back Pain (MLBP) is musculoskeletal pain of soft tissue origin that can be seen in the posterior lumbal region, sacral region or paraspinal region. MLBP, which is characterized by tendonitis, trigger points and muscle spasms, increases with movement and decreases with rest.

Muscle Energy Technique (MET) is a manual therapeutic procedure that creates voluntary contractions in skeletal muscles by creating force against the practitioner by the patient. MET is used to lengthen shortened muscles, mobilize restricted joints, and strengthen physiologically weakened muscles (Chaitow 2013).

Treatment methods generally applied to patients diagnosed with MLBP; physical therapy modalities, manual techniques, exercise therapy, medical therapy, psychological therapy and patient education. It is recommended that MET be used to reduce pain when administered to the spine (Wilson 2003) or muscles (Ballantyne et al. 2003).

The aim of our study is to investigate the efficiency of Muscle Energy Technique on spinal mobility, flexibility, pain, disability, fear avoidance behavior, quality of life and depressive symptoms in female patients with mechanical low back pain.

Eligibility Criteria:
Inclusion Criteria:

* being a volunteer female between the ages of 30 and 45
* having a complaint of low back pain for at least 3 months with the diagnosis of mechanical low back pain

Exclusion Criteria:

* having previous spinal surgery
* having radicular type low back pain
* having neuromuscular disease
Impact of Extent of Antral Resection on Outcomes of Sleeve Gastrectomy

Laparoscopic sleeve gastrectomy (LSG) is a surgical technique that treats morbid obesity by both restrictive and hormonal action.

Consecutive patients with morbid obesity treated by LSG at our department were evaluated. Patients enrolled in the study were randomized into Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

This prospective randomized study was designed to compare between the beginning of sleeve gastrectomy 2 cm versus 6 cm from the pylorus with special regards to intraoperative problems, weight loss, improvement of comorbidities, postoperative complications, nutritional and elemental deficiencies.

Consecutive patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG) at the department of general surgery, Mansoura University, Egypt, during the period from January 2008 to January 2012, were eligible for the study. The exclusion criteria included patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.

The operation was done under general anesthesia. Patient was in supine position with splitting of the operating table legs.Gastric transection started 2 cm proximal to the pylorus using 60 mm, green endo-stapler (Ethicon, USA) (GI) or 6 cm from the pylorus (G II). The following staplers were placed approximately 1 cm from the bougie in the direction of the gastroesophageal junction.

Group I: LSG begin the division 2 cm from the pylorus and Group II: LSG begin the division 6 cm from the pylorus. The primary outcome measure was the % of excess weight loss (%EWL); secondary outcomes included operative time, day to resume oral feeding, postoperative morbidity and mortality, improvement of comorbidity.

Eligibility Criteria:
Inclusion Criteria:

* patients, who were treated for morbid obesity by laparoscopic sleeve gastrectomy (LSG)

Exclusion Criteria:

* patients above 60 or below 18 years old, history of upper laparotomy, unfit for anaesthesia or laparoscopy, major psychological instability, and drug abuse.
The Effects of Kinesio Taping in Women With Primary Dysmenorrhea

The aim of our study was to investigate the effects of kinesio taping in women with primary dysmenorrhea.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years of age,
* having Primary Dysmenorrhea
* being volunteer women

Exclusion Criteria:

* having give birth,
* having a serious psychiatric disorder
* having used oral contraceptive or depression drug in the last 6 month
* having secondary dysmenorrhea
* having irregular menstrual cycle
* having allergy to taping